What to do when the unwanted happens? Negative event management in studies on internet- and mobile-based interventions for youths and adults with two case reports.

Background: Despite severely burdened individuals, often being excluded from research studies on internet- and mobile-based interventions (IMIs), negative events (NEs) including suicidal thoughts and behaviors (STBs) can still occur during a trial. NEs require monitoring and adequate safety measures. However, study protocols frequently lack comprehensive descriptions of procedures for managing NEs. Aims: This study aimed to illustrate the assessment, monitoring, and procedures for addressing NEs in two studies on IMIs in adults and youth using case reports, to identify strengths and weaknesses of the NE management approaches, and to derive key learnings and recommendations. Methods: Two case reports were drawn from two distinct IMI studies. The first study, PSYCHOnlineTHERAPY, evaluates the combination of an IMI with on-site psychotherapy for anxiety and depressive disorders in adults (adult blended study). The second study evaluates a standalone, therapist-guided IMI for post-traumatic stress disorder (PTSD) in youth (youth standalone study). Potential NEs were predefined depending on the study sample. The case studies thoroughly document the systematic recording and ongoing monitoring of NEs through self-report and observer-based assessments during the interventions. The cases illustrate a variety of NE management strategies, including automated and personalized approaches, adapted to the specific nature and severity of the NEs. The NE management approaches are visualized using decision trees. Results: In the adult blended case study, online questionnaires detected STBs and triggered automated support information. As on-site therapy had already ended, a telephone consultation session allowed for the identification and discussion of the heightened intensity of suicidal thoughts, along with the development of specific additional help options. In the youth standalone case study, heightened tension in an adolescent with PTSD during trauma processing could be addressed in a telephone therapeutic session focusing on resource activation and emotion regulation. The referral to on-site treatment was supported. Overall, advantages of the NE management included automated procedures, multimodal assessment of a wide range of NEs, and standardized procedures tailored to different severity levels. Weaknesses included the use of single-item assessments for STBs and lack of procedures in case of deterioration or nonresponse to treatment. Conclusion: This study provides practical insights and derives key learnings and recommendations regarding the management of NEs in different IMI contexts for both adults and youth.

Validation of the German Normalisation Process Theory Measure G-NoMAD: translation, adaptation, and pilot testing.

BACKGROUND: Implementing evidence-based healthcare practices (EBPs) is a complex endeavour and often lags behind research-informed decision processes. Understanding and systematically improving implementation using implementation theory can help bridge the gap between research findings and practice. This study aims to translate, pilot, and validate a German version of the English NoMAD questionnaire (G-NoMAD), an instrument derived from the Normalisation Process Theory, to explore the implementation of EBPs. METHODS: Survey data has been collected in four German research projects and subsequently combined into a validation data set. Two versions of the G-NoMAD existed, independently translated from the original English version by two research groups. A measurement invariance analysis was conducted, comparing latent scale structures between groups of respondents to both versions. After determining the baseline model, the questionnaire was tested for different degrees of invariance (configural, metric, scalar, and uniqueness) across samples. A confirmatory factor analysis for three models (a four-factor, a unidimensional, and a hierarchical model) was used to examine the theoretical structure of the G-NoMAD. Finally, psychometric results were discussed in a consensus meeting, and the final instructions, items, and scale format were consented to. RESULTS: A total of 539 health care professionals completed the questionnaire. The results of the measurement invariance analysis showed configural, partial metric, and partial scalar invariance indicating that the questionnaire versions are comparable. Internal consistency ranged from acceptable to good (0.79 ≤ α ≤ 0.85) per subscale. Both the four factor and the hierarchical model achieved a better fit than the unidimensional model, with indices from acceptable (SRMR = 0.08) to good (CFI = 0.97; TLI = 0.96). However, the RMSEA values were only close to acceptable (four-factor model: χ2164 = 1029.84, RMSEA = 0.10; hierarchical model: χ2166 = 1073.43, RMSEA = 0.10). CONCLUSIONS: The G-NoMAD provides a reliable and promising tool to measure the degree of normalisation among individuals involved in implementation activities. Since the fit was similar in the four-factor and the hierarchical model, priority should be given to the practical relevance of the hierarchical model, including a total score and four subscale scores. The findings of this study support the further usage of the G-NoMAD in German implementation settings. TRIAL REGISTRATION: Both the AdAM project (No. NCT03430336, 06/02/2018) and the EU-project ImpleMentAll (No. NCT03652883, 29/08/2018) were registered on ClinicalTrials.gov. The ImplementIT study was registered at the German Clinical Trial Registration (No. DRKS00017078, 18/04/2019). The G-NoMAD validation study was registered at the Open Science Framework (No7u9ab, 17/04/2023).

How to promote usage of telehealth interventions for farmers' mental health? A qualitative study on supporting and hindering aspects for acceptance and satisfaction with a personalized telephone coaching for depression prevention.

Low-threshold and remotely delivered preventive interventions, like telephone coaching, are warranted for farmers who experience multiple risk factors for depression, live in underserved areas, and show low help-seeking behavior. Factors facilitating uptake and actual use of effective remote interventions are important to reduce depression disease burden. This study aimed at identifying factors that potentially can influence acceptance of and satisfaction with a telephone coaching in this occupational group.Semi-structured interviews were based on the 'Unified Theory of Acceptance and Use of Technology', the 'Evaluation', and 'Discrepancy' models for satisfaction. Interviews were conducted with 20 of 66 invited participants of a 6-months telephone coaching during an effectiveness or implementation study. Audio-recorded interviews were transcribed and analyzed (deductive-inductive qualitative content analysis). Independent coding by two persons resulted in good agreement (Κ = 0.80). Participants validated results via questionnaire.Overall, 32 supporting (SF) and 14 hindering factors (HF) for acceptance and satisfaction were identified and organized into five dimensions: Coaching result (SF = 9, HF = 3), coach (SF = 9, HF = 1), organization (SF = 5, HF = 2), the telephone as communication medium (SF = 4, HF = 5) and participant characteristics (SF = 5, HF = 3). Most named SFs were 'Flexible appointment arrangement' (n = 19/95 %) and 'low effort' (n = 17/85 %), while most reported HFs were 'lack of visual cues' (n = 12/60 %) and 'social/professional involvement restricts change process' (n = 10/50 %).The perceived changes initiated by coaching, a low effort through telephone conduct, and the indicated personalization were identified as important influencing factors on acceptance and satisfaction based on interviewees' statements. Both may be further enhanced by offering choice and advice for delivery formats (e.g., video-calls) and training of coaches in farm-related issues. Study registration: German Clinical Trial Registrations: DRKS00017078 and DRKS00015655.

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

Barriers to and Facilitators of Engaging With and Adhering to Guided Internet-Based Interventions for Depression Prevention and Reduction of Pain-Related Disability in Green Professions: Mixed Methods Study.

BACKGROUND: Internet-based interventions (IBIs) are effective for the prevention and treatment of mental disorders and are valuable additions for improving routine care. However, the uptake of and adherence to IBIs are often limited. To increase the actual use of IBIs, it is important to identify factors for engaging with and adhering to IBIs. OBJECTIVE: We qualitatively evaluated barriers and facilitators regarding a portfolio of guided IBIs in green professions (farmers, gardeners, and foresters). METHODS: Interview participants were selected from 2 randomized controlled trials for either the prevention of depression (Prevention of Depression in Agriculturists [PROD-A]) or the reduction of pain interference (Preventive Acceptance and Commitment Therapy for Chronic Pain in Agriculturists [PACT-A]) in green professions. The intervention group in PROD-A (N=180) participated in an IBI program, receiving access to 1 of 6 symptom-tailored IBIs. The intervention group in PACT-A (N=44) received access to an IBI for chronic pain. Overall, 41 semistructured qualitative interviews were conducted and transcribed verbatim. Barriers and facilitators were identified via inductive qualitative content analysis, with 2 independent coders reaching almost perfect intercoder reliability (Cohen κ=0.92). A quantitative follow-up survey (30/41, 73%) was conducted to validate the results. Subgroup analyses were performed based on intervention characteristics. RESULTS: We identified 42 barriers and 26 facilitators, which we assigned to 4 superordinate categories related to the intervention (20 barriers; 17 facilitators), work (4 barriers; 1 facilitator), individual (13 barriers; 8 facilitators), and technical (5 barriers; 0 facilitators) aspects. Key barriers (identified by at least 50% of the interviewees) were time-consuming work life (29/40, 73%) and time-consuming private life (23/40, 58%). Similarly, the most frequently identified facilitators included presence of motivation, curiosity, interest and perseverance (30/40, 75%), flexible time management at work (25/40, 63%), and support from family and friends (20/40, 50%). Although agreement with barriers in the quantitative follow-up survey was rather low (mean 24%, SD 11%), agreement with facilitators was substantially higher (mean 80%, SD 13%). Differences in agreement rates were found particularly between intervention completers and noncompleters. Completers agreed significantly more often that perceived IBI success; being motivated, curious, interested, and perseverant; and having a persisting level of psychological strain have been facilitating. Noncompleters agreed more often with experiencing the e-coach contact as insufficient and technical problems as hindering for intervention completion. CONCLUSIONS: Based on these results, strategies such as customization of modules for more flexible and adaptive use; video chat options with the e-coach; options to facilitate social support by family, friends, or other participants; or using prompts to facilitate training completion can be derived. These approaches could be evaluated in further quantitative research designs in terms of their potential to enhance intervention use in this occupational group. TRIAL REGISTRATION: German Clinical Trials Register DRKS00014000, https://tinyurl.com/3bukfr48; German Clinical Trials Register DRKS0001461, https://tinyurl.com/ebsn4sns.

Lessons Learned from an Attempted Pragmatic Randomized Controlled Trial for Improvement of Chronic Pain-Associated Disability in Green Professions: Long-Term Effectiveness of a Guided Online-Based Acceptance and Commitment Therapy (PACT-A).

Musculoskeletal symptoms are increased in farmers, whereas the prevalence of chronified pain is unknown. Online interventions based on acceptance and commitment therapy (ACT) have shown encouraging results in the general population, representing a promising approach for reducing pain interference in green professions (i.e., farmers, foresters, gardeners). We conducted a pragmatic RCT comparing a guided ACT-based online intervention to enhanced treatment-as-usual in entrepreneurs, contributing spouses, family members and pensioners in green professions with chronic pain (CPG: ≥grade II, ≥6 months). Recruitment was terminated prematurely after 2.5 years at N = 89 (of planned N = 286). Assessments were conducted at 9 weeks (T1), 6 months (T2) and 12 months (T3) post-randomization. The primary outcome was pain interference (T1). The secondary outcomes encompassed pain-, health- and intervention-related variables. No treatment effect for reduction of pain interference was found at T1 (ß = -0.16, 95%CI: -0.64-0.32, p = 0.256). Improvements in cognitive fusion, pain acceptance, anxiety, perceived stress and quality of life were found only at T3. Intervention satisfaction as well as therapeutic and technological alliances were moderate, and uptake and adherence were low. Results are restricted by low statistical power due to recruitment issues, high study attrition and low intervention adherence, standing in contrast to previous studies. Further research is warranted regarding the use of ACT-based online interventions for chronic pain in this occupational group. Trial registration: German Clinical Trial Registration: DRKS00014619. Registered: 16 April 2018.

Digital prevention of depression for farmers? A qualitative study on participants' experiences regarding determinants of acceptance and satisfaction with a tailored guided internet intervention program.

Introduction: Farmers, forest workers and gardeners have a higher risk of developing depression compared to other occupational populations. As part of the German pilot project "With us in balance", the potential of six guided internet- and mobile-based interventions (IMIs) to prevent depression among their insurants is examined. The IMI program is tailored to various risk factors of depression, individual symptoms, and needs. Although IMIs have been shown to be effective in reducing depressive symptoms, there is little qualitative research about the acceptance of digital preventive IMIs. The aim of this qualitative study is to gain insights into participants' experiences with the guided IMIs by focusing on determinants for acceptance and satisfaction. Methods: Semi-structured interviews were conducted with 22/171 (13 %) intervention group (IG) participants of a randomized controlled trial. The interview guide was developed based on theoretical models of user acceptance (Unified Theory of Acceptance and Use of Technology) and patient satisfaction (evaluation model, discrepancy theory). The interviews were evaluated independently by two coders performing a deductive-inductive content analysis and attaining a substantial level of agreement (K = 0.73). Results: The qualitative analysis revealed 71 determinants for acceptance and satisfaction across ten dimensions: performance expectancy, organisation, e-coach, usability, training content and structure, training usage, training outcome, financing, social influence, and behavioural intention. The most frequently identified drivers for the IMI use include "location independence", "positive relationship to the e-coach" (each n = 19, 86 %), "personal e-coach guidance", "expertise of the e-coach", "target group specific adaptation" (each n = 18, 82 %), "flexibility", "high willingness for renewed participation" (each n = 17, 77 %), "fast and easy availability", "training of health enhancing attitudes and behaviours" and "content with figurative expressions" (each n = 16, 73 %). Discussion: The qualitative findings predominantly suggest the acceptance of and satisfaction with the IMI program for the prevention of depression in famers and related lines of work. Many identified positive drivers are related to the e-coach guidance, which emphasizes its importance in the preventive setting from the perspective of the participants. Nevertheless, some negative aspects have been identified which help to understand potential weaknesses of the IMI program. Participants indicated different needs in terms of IMI content and usage, which points towards the potential benefit of individualisation. The possibility of being able to use IMIs anonymously, flexibly and independently of location might be highly relevant for this specific target group.

Telephone coaching for the prevention of depression in farmers: Results from a pragmatic randomized controlled trial.

INTRODUCTION: Farmers have a high risk for depression (MDD). Preventive measures targeting this often remotely living population might reduce depression burden. The study aimed to evaluate the effectiveness of personalized telephone coaching in reducing depressive symptom severity and preventing MDD in farmers compared to enhanced treatment as usual (TAU + ). METHODS: In a two-armed, pragmatic randomized controlled trial (N = 314) with post-treatment at 6 months, farming entrepreneurs, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) were randomized to personalized telephone coaching or TAU + . The coaching was provided by psychologists and consists on average of 13 (±7) sessions a 48 min (±15) over 6 months. The primary outcome was depressive symptom severity (QIDS-SR16). RESULTS: Coaching participants showed a significantly greater reduction in depressive symptom severity compared to TAU + (d = 0.39). Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset. Further significant effects in favor of the intervention group were found for stress (d = 0.34), anxiety (d = 0.30), somatic symptoms (d = 0.39), burnout risk (d = 0.24-0.40) and quality of life (d = 0.28). DISCUSSION: Limiting, we did not apply an upper cutoff score for depressive symptom severity or controlled for previous MDD episodes, leaving open whether the coaching was recurrence/relapse prevention or early treatment. Nevertheless, personalized telephone coaching can effectively improve mental health in farmers. It could play an important role in intervening at an early stage of mental health problems and reducing disease burden related to MDD. TRIAL REGISTRATION NUMBER AND TRIAL REGISTER: German Clinical Trial Registration: DRKS00015655.

A Data-Driven Clustering Method for Discovering Profiles in the Dynamics of Major Depressive Disorder Using a Smartphone-Based Ecological Momentary Assessment of Mood.

Background: Although major depressive disorder (MDD) is characterized by a pervasive negative mood, research indicates that the mood of depressed patients is rarely entirely stagnant. It is often dynamic, distinguished by highs and lows, and it is highly responsive to external and internal regulatory processes. Mood dynamics can be defined as a combination of mood variability (the magnitude of the mood changes) and emotional inertia (the speed of mood shifts). The purpose of this study is to explore various distinctive profiles in real-time monitored mood dynamics among MDD patients in routine mental healthcare. Methods: Ecological momentary assessment (EMA) data were collected as part of the cross-European E-COMPARED trial, in which approximately half of the patients were randomly assigned to receive the blended Cognitive Behavioral Therapy (bCBT). In this study a subsample of the bCBT group was included (n = 287). As part of bCBT, patients were prompted to rate their current mood (on a 1-10 scale) using a smartphone-based EMA application. During the first week of treatment, the patients were prompted to rate their mood on three separate occasions during the day. Latent profile analyses were subsequently applied to identify distinct profiles based on average mood, mood variability, and emotional inertia across the monitoring period. Results: Overall, four profiles were identified, which we labeled as: (1) "very negative and least variable mood" (n = 14) (2) "negative and moderate variable mood" (n = 204), (3) "positive and moderate variable mood" (n = 41), and (4) "negative and highest variable mood" (n = 28). The degree of emotional inertia was virtually identical across the profiles. Conclusions: The real-time monitoring conducted in the present study provides some preliminary indications of different patterns of both average mood and mood variability among MDD patients in treatment in mental health settings. Such varying patterns were not found for emotional inertia.

Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis.

BACKGROUND: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. OBJECTIVE: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. METHODS: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. RESULTS: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (ß=.16, 95% CI -0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (ß=.49, 95% CI 0.22-0.76) but not for TAU (ß=-.23, 95% CI -0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (ß=.06, 95% CI -0.11 to 0.23) or 6-month (ß=.09, 95% CI -0.10 to 0.28) follow-up. CONCLUSIONS: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Using the Consolidated Framework for Implementation Research to evaluate a nationwide depression prevention project (ImplementIT) from the perspective of health care workers and implementers: Results on the implementation of digital interventions for farmers.

Introduction: Depression has a significant impact on individuals and society, which is why preventive measures are important. Farmers represent an occupational group exposed to many risk factors for depression. The potential of guided, tailored internet-based interventions and a personalized telephone coaching is evaluated in a German project of the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG). While user outcomes are promising, not much is known about actual routine care use and implementation of the two digital health interventions. This study evaluates the implementation from the perspective of social insurance employees to understand determinants influencing the uptake and implementation of digital interventions to prevent depression in farmers. Methods: The data collection and analysis are based on the Consolidated Framework for Implementation Research (CFIR). Health care workers (n = 86) and implementers (n = 7) completed online surveys and/or participated in focus groups. The surveys consisted of validated questionnaires used in implementation research, adapted items from the CFIR guide or from other CFIR studies. In addition, we used reporting data to map implementation based on selected CFIR constructs. Results: Within the five CFIR dimensions, many facilitating factors emerged in relation to intervention characteristics (e.g., relative advantage compared to existing services, evidence and quality) and the inner setting of the SVLFG (e.g., tension for change, compatibility with values and existing working processes). In addition, barriers to implementation were identified in relation to the outer setting (patient needs and resources), inner setting (e.g., available resources, access to knowledge and information) and characteristics of individuals (e.g., self-efficacy). With regard to the implementation process, facilitating factors (formal implementation leaders) as well as hindering factors (reflecting and evaluating) were identified. Discussion: The findings shed light on the implementation of two digital prevention services in an agricultural setting. While both offerings seem to be widely accepted by health care workers, the results also point to revealed barriers and contribute to recommendations for further service implementation. For instance, special attention should be given to "patient needs and resources" by raising awareness of mental health issues among the target population as well as barriers regarding the inner setting. Clinical Trial Registration: German Clinical Trial Registration: [DRKS00017078]. Registered on 18.04.2019.

Are guided internet-based interventions for the indicated prevention of depression in green professions effective in the long run? Longitudinal analysis of the 6- and 12-month follow-up of a pragmatic randomized controlled trial (PROD-A).

OBJECTIVE: Evidence of long-term stability for positive mental health effects of internet-based interventions (IBIs) for depression prevention is still scarce. We evaluate long-term effectiveness of a depression prevention program in green professions (i.e. agriculture, horticulture, forestry). METHODS: This pragmatic RCT (n = 360) compares a tailored IBI program to enhanced treatment as usual (TAU+) in green professions with at least subthreshold depression (PHQ ≥ 5). Intervention group (IG) received one of six IBIs shown previously to efficaciously reduce depressive symptoms. We report 6- and 12-month follow-up measures for depression, mental health and intervention-related outcomes. Intention-to-treat and per-protocol regression analyses were conducted for each measurement point and complemented by latent growth modeling. RESULTS: After 6 months, depression severity (ß = -0.30, 95%-CI: -0.52; -0.07), insomnia (ß = -0.22, 95%-CI: -0.41; -0.02), pain-associated disability (ß = -0.26, 95%-CI: -0.48; -0.04) and quality of life (ß = 0.29, 95%-CI: 0.13; 0.45) in IG were superior to TAU+. Onset of possible depression was not reduced. After 12 months, no intervention effects were found. Longitudinal modeling confirmed group effects attenuating over 12 months for most outcomes. After 12 months, 55.56% of IG had completed at least 80% of their IBI. CONCLUSIONS: Stability of intervention effects along with intervention adherence was restricted. Measures enhancing long-term effectiveness of IBIs for depression health promotion are indicated in green professions. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.

Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study.

BACKGROUND: Behavioral activation (BA), either as a stand-alone treatment or as part of cognitive behavioral therapy, has been shown to be effective for treating depression. The theoretical underpinnings of BA derive from Lewinsohn et al's theory of depression. The central premise of BA is that having patients engage in more pleasant activities leads to them experiencing more pleasure and elevates their mood, which, in turn, leads to further (behavioral) activation. However, there is a dearth of empirical evidence about the theoretical framework of BA. OBJECTIVE: This study aims to examine the assumed (temporal) associations of the 3 constructs in the theoretical framework of BA. METHODS: Data were collected as part of the "European Comparative Effectiveness Research on Internet-based Depression Treatment versus treatment-as-usual" trial among patients who were randomly assigned to receive blended cognitive behavioral therapy (bCBT). As part of bCBT, patients completed weekly assessments of their level of engagement in pleasant activities, the pleasure they experienced as a result of these activities, and their mood over the course of the treatment using a smartphone-based ecological momentary assessment (EMA) application. Longitudinal cross-lagged and cross-sectional associations of 240 patients were examined using random intercept cross-lagged panel models. RESULTS: The analyses did not reveal any statistically significant cross-lagged coefficients (all P>.05). Statistically significant cross-sectional positive associations between activities, pleasure, and mood levels were identified. Moreover, the levels of engagement in activities, pleasure, and mood slightly increased over the duration of the treatment. In addition, mood seemed to carry over, over time, while both levels of engagement in activities and pleasurable experiences did not. CONCLUSIONS: The results were partially in accordance with the theoretical framework of BA, insofar as the analyses revealed cross-sectional relationships between levels of engagement in activities, pleasurable experiences deriving from these activities, and enhanced mood. However, given that no statistically significant temporal relationships were revealed, no conclusions could be drawn about potential causality. A shorter measurement interval (eg, daily rather than weekly EMA reports) might be more attuned to detecting potential underlying temporal pathways. Future research should use an EMA methodology to further investigate temporal associations, based on theory and how treatments are presented to patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02542891, https://clinicaltrials.gov/ct2/show/NCT02542891; German Clinical Trials Register, DRKS00006866, https://tinyurl.com/ybja3xz7; Netherlands Trials Register, NTR4962, https://www.trialregister.nl/trial/4838; ClinicalTrials.Gov, NCT02389660, https://clinicaltrials.gov/ct2/show/NCT02389660; ClinicalTrials.gov, NCT02361684, https://clinicaltrials.gov/ct2/show/NCT02361684; ClinicalTrials.gov, NCT02449447, https://clinicaltrials.gov/ct2/show/NCT02449447; ClinicalTrials.gov, NCT02410616, https://clinicaltrials.gov/ct2/show/NCT02410616; ISRCTN registry, ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725.

Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders.

Introduction: Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible and resource optimized way. Objective: The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT). Methods: A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPYfix/flex) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of N = 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0-16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed. Discussion: PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care. Trial Registration: The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020).

Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.

BACKGROUND: Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions. METHODS: This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1. RESULTS: A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (ß=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low. LIMITATIONS: Results are limited to green professions and representativeness might be restricted by self-selection of participants. CONCLUSION: Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. METHODS: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. DISCUSSION: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.

INTRODUCTION: Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+). METHODS AND ANALYSIS: A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17-FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.

Implementing internet- and tele-based interventions to prevent mental health disorders in farmers, foresters and gardeners (ImplementIT): study protocol for the multi-level evaluation of a nationwide project.

BACKGROUND: Farmers are a vulnerable population for developing depression or other mental health disorders due to a variety of risk factors in their work context. Beyond face-to-face resources, preventive internet- and tele-based interventions could extend available treatment options to overcome barriers to care. The German Social Insurance Company for Agriculture, Forestry and Horticulture (SVLFG) implements several guided internet- and mobile-based interventions and personalised tele-based coaching for this specific target group provided by external companies within a nation-wide prevention project for their insured members. The current study aims to evaluate the implementation process and to identify determinants of successful implementation on various individual and organisational levels. METHODS: The current study includes two groups of participants: 1) insured persons with an observable need for prevention services, and 2) staff-participants who are involved in the implementation process. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Consolidated Framework for Implementation Research (CFIR) will be used to track and evaluate the implementation process. A mixed-method approach will provide insights on individual and organizational level (e.g. degree of normalization, readiness for change) and helps to identify determinants of successful implementation. In-depth insights on experiences of the participants (e.g. acceptance, satisfaction, barriers and facilitating factors of intervention use) will be yielded through qualitative interviews. Focus groups with field workers provide insights into barriers and facilitators perceived during their consultations. Furthermore, intervention as well as implementation costs will be evaluated. According to the stepwise, national rollout, data collection will occur at baseline and continuously across 24 months. DISCUSSION: The results will show to what extent the implementation of the internet- and tele-based services as a preventive offer will be accepted by the participants and involved employees and which critical implementation aspects will occur within the process. If the implementation of the internet- and tele-based services succeeds, these services may be feasible in the long-term. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00017078 . Registered on 18.04.2019.

Barriers and Facilitators for Referrals of Primary Care Patients to Blended Internet-Based Psychotherapy for Depression: Mixed Methods Study of General Practitioners' Views.

BACKGROUND: Major depressive disorder (MDD) is highly prevalent and often managed by general practitioners (GPs). GPs mostly prescribe medication and show low referral rates to psychotherapy. Many patients remain untreated. Blended psychotherapy (bPT) combines internet-based interventions with face-to-face psychotherapy and could increase treatment access and availability. Effectively implementing bPT in routine care requires an understanding of professional users' perspectives and behavior. OBJECTIVE: This study aims to identify barriers and facilitators perceived by GPs in referring patients to bPT. Explanations for variations in referral rates were examined. METHODS: Semistructured interviews were conducted with 12 of 110 GPs participating in a German randomized controlled trial (RCT) to investigate barriers to and facilitators for referrals to bPT for MDD (10 web-based modules, app-based assessments, and 6 face-to-face sessions). The interview guide was based on the theoretical domains framework. The interviews were audio recorded and transcribed verbatim, and the qualitative content was analyzed by 2 independent coders (intercoder agreement, k=0.71). A follow-up survey with 12 interviewed GPs enabled the validation of emergent themes. The differences in the barriers and facilitators identified between groups with different characteristics (eg, GPs with high or low referral rates) were described. Correlations between referrals and characteristics, self-rated competences, and experiences managing depression of the RCT-GPs (n=76) were conducted. RESULTS: GPs referred few patients to bPT, although varied in their referral rates, and interviewees referred more than twice as many patients as RCT-GPs (interview-GPs: mean 6.34, SD 9.42; RCT-GPs: mean 2.65, SD 3.92). A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-0.31, P<.001. The qualitative findings revealed a total of 19 barriers (B) and 29 facilitators (F), at the levels of GP (B=4 and F=11), patient (B=11 and F=9), GP practice (B=1 and F=3), and sociopolitical circumstances (B=3 and F=6). Key barriers stated by all interviewed GPs included "little knowledge about internet-based interventions" and "patients' lack of familiarity with technology/internet/media" (number of statements, each k=22). Key facilitators were "perceived patient suitability, e.g. well-educated, young" (k=22) and "no conflict with GP's role" (k=16). The follow-up survey showed a very high agreement rate of at least 75% for 71% (34/48) of the identified themes. Descriptive findings indicated differences between GPs with low and high referral rates in terms of which and how many barriers (low: mean 9.75, SD 1.83; high: mean 10.50, SD 2.38) and facilitators (low: mean 18.25, SD 4.13; high: mean 21.00; SD 3.92) they mentioned. CONCLUSIONS: This study provides insights into factors influencing GPs' referrals to bPT as gatekeepers to depression care. Barriers and facilitators should be considered when designing implementation strategies to enhance referral rates. The findings should be interpreted with care because of the small and self-selected sample and low response rates.

Clinical and Cost-Effectiveness of Personalized Tele-Based Coaching for Farmers, Foresters and Gardeners to Prevent Depression: Study Protocol of an 18-Month Follow-Up Pragmatic Randomized Controlled Trial (TEC-A).

Background: Farmers show high levels of depressive symptoms and mental health problems in various studies. This study is part of a nationwide prevention project carried out by a German social insurance company for farmers, foresters, and gardeners (SVLFG) to implement internet- and tele-based services among others to improve mental health in this population. The aim of the present study is to evaluate the (cost-)effectiveness of personalized tele-based coaching for reducing depressive symptom severity and preventing the onset of clinical depression, compared to enhanced treatment as usual. Methods: In a two-armed, pragmatic randomized controlled trial (N = 312) with follow-ups at post-treatment (6 months), 12 and 18 months, insured farmers, foresters, and gardeners, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) will be randomly allocated to personalized tele-based coaching or enhanced treatment as usual. The coaching is provided by psychologists and consists of up to 34 tele-based sessions for 25-50 min delivered over 6 months. Primary outcome is depressive symptom severity at post-treatment. Secondary outcomes include depression onset, anxiety, stress, and quality of life. A health-economic evaluation will be conducted from a societal perspective. Discussion: This study is the first pragmatic randomized controlled trial evaluating the (cost-)effectiveness of a nationwide tele-based preventive service for farmers. If proven effective, the implementation of personalized tele-based coaching has the potential to reduce disease burden and health care costs both at an individual and societal level. Clinical Trial Registration: German Clinical Trial Registration: DRKS00015655.