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.

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.

Reducing problematic alcohol use in employees: economic evaluation of guided and unguided web-based interventions alongside a three-arm randomized controlled trial.

AIMS: To perform an economic evaluation of guided and unguided internet-based interventions to reduce problematic alcohol consumption in employees compared with a waiting-list control condition (WLC) with unrestricted access to treatment-as-usual. DESIGN: A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a societal and a cost-benefit analysis from the employer's perspective with a 6-month time horizon. SETTING: Open recruitment in the German working population. PARTICIPANTS: Employees (178 males, 256 females, mean age 47 years) consuming at least 14 (women) or 21 (men) standard units of alcohol (SUAs) per week and scoring ≥ 8 (men) or 6 (women) on the Alcohol Use Disorders Identification Test. MEASUREMENTS: On-line questionnaires administered to assess SUAs and assess quality of life (AQoL-8D) and resource use. Outcome measure was responder (≤ 14/≤ 21 SUAs) for the CEA and quality-adjusted life years (QALYs) for the CUA. Net benefit regression was used to estimate cost-effectiveness for each study arm. Bootstrapping and sensitivity analyses were performed to account for uncertainty. INTERVENTIONS: Five weekly modules including personalized normative feedback, motivational interviewing, goal setting, problem-solving and emotion regulation, provided with adherence-focused guidance [n = 142; responders: n = 73 (51.4%); QALYs = 0.364, standard error (SE) = 0.006] or without guidance [n = 146; n = 66 (45.2%); 0.359, 0.007]. Controls were on a waiting-list [n = 144; n = 38 (26.4%); 0.342, 0.007]. FINDINGS: From a societal perspective, the guided intervention had a probability of 55% (54%) of being the most efficient strategy at a willingness-to-pay (WTP) of €0 per responder (QALY) gained, compared with the unguided intervention and the control condition. At a WTP of €20 000 per QALY gained, the probability was 78%. From an employer's perspective, the guided intervention had a higher probability of a positive return on investment (81%) compared with the unguided intervention (58%). CONCLUSION: A guided internet-based intervention to reduce problematic alcohol consumption in employees appears to be both cost-beneficial and cost-effective.

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.

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.

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.

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.

Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial.

BACKGROUND: People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+). METHODS: A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6-8 modules, duration: 6-8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants' symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach. DISCUSSION: This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00014000 . Registered on 09 April 2018.

Assessing Communication Skills in Real Medical Encounters in Oncology: Development and Validation of the ComOn-Coaching Rating Scales.

One of the challenges in research on teaching physician-patient communication is how to assess communication, necessary for evaluating training, the learning process, and for feedback. Few instruments have been validated for real physician-patient consultations. Real consultations involve unique contexts, different persons, and topics, and are difficult to compare. The aim of this study is to develop and validate a rating scale for assessment of such consultations. For the evaluation study of a communication skills training for physicians in oncology, real consultations were recorded in three assessment points. Based on earlier work and on current studies, a new instrument was developed for assessment of these consultations. Two psychologists were trained in using the instrument and assessed 42 consultations. For inter-rater reliability, interclass correlation (ICC) was calculated. The final version of the rating scales consists of 13 items evaluated on a 5-point scale. The items are grouped in seven areas: "Start of conversation," "assessment of the patient's perspective," "structure of conversation," "emotional issues," "end of conversation," "general communication skills," and "overall evaluation." ICC coefficients for the domains ranged from .44 to .77. An overall coefficient of all items resulted in an ICC of .66. The ComOn-Coaching Rating Scales are a short, reliable, and applicable instrument for the assessment of real physician-patient consultations in oncology. If adapted, they could be used in other areas. They were developed for research and teaching purposes and meet the required methodological criteria. Rater training should be considered more deeply by further research.

Exploring urban health in Cape Town, South Africa: an interdisciplinary analysis of secondary data.

BACKGROUND: With modern information technology, an overwhelming amount of data is available on different aspects of societies. Our research investigated the feasibility of using secondary data sources to get an overview of determinants of health and health outcomes in different population strata of Cape Town, a large city of South Africa. METHODS: The methodological approach of secondary-data analysis was similar in the different disciplines: Biological Anthropology, Public Health, Environmental Health, Mental Health, Palliative Care, Medical Psychology and Sociology at the University of Freiburg and Public Health at the University of Cape Town. The teams collected information on Cape Town through Internet searches and published articles. The information was extracted, analyzed, condensed, and jointly interpreted. RESULTS: Data show the typical picture of a population in epidemiological and demographic transition exposed to often difficult social, mental, and physical environmental conditions. Comparison between low and higher socioeconomic districts demonstrated that the former had higher air pollution, poorer water quality, and deficient sanitary conditions in addition to sub-optimal mental health services and palliative care. CONCLUSION: Although important information gaps were identified, the data draw attention to critical public health interventions required in poor health districts, and to motivate for pro-equity policies.