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).

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.

["iFightDepression" in inpatient treatment : Evaluation of a web-based, therapist-guided self-management program on a specialized ward for affective disorders]. / "iFightDepression" im stationären Setting : Evaluation eines internetbasierten, therapeutenbegleiteten Selbstmanagementprogramms auf einer Spezialstation für affektive Störungen.

BACKGROUND: E­mental health mainly plays a role in the outpatient treatment of patients with depressive disorders. The goal of this study was to implement and evaluate the web-based, therapist-guided self-management tool "iFightDepression" (iFD) to clarify if there is a benefit for inpatient use. MATERIAL AND METHODS: In this study 78 inpatients with affective disorders (ICD-10 F32.0­3, F33.0-3) or dysthymia (F34) were recruited. The intervention duration with the iFD tool went from admission until discharge, therapeutic support was granted by the ward staff. Symptom severity, intervention expectations and experience with therapy were processed in an online questionnaire before the intervention (T0) while intervention satisfaction was captured after the intervention shortly before discharge (T1) in a paper-pencil questionnaire. RESULTS: Out of 78 participating inpatients 42 used the iFD tool at least once. Moderate to high levels of expectation regarding the iFD tool and mildly above-average level of satisfaction after the intervention were observed. Of the active users 67% indicated they would continue to use the iFD tool after discharge. The main reasons for not using the iFD tool were short duration of stay, severity of disease and lack of digital literacy. CONCLUSION: An implementation of the iFD tool is feasible on principle. Active users gave positive feedback concerning the intervention and most participants claimed to continue using the iFD tool after discharge; however, low usage rates among study participants (42/78, 54%) showed barriers of implementation that have to be addressed and underline the importance of adaptations regarding the use of the intervention in a clinical setting.

How are guide profession and routine care setting related to adherence and symptom change in iCBT for depression? - an explorative log-data analysis.

BACKGROUND: While the antidepressant efficacy of guided digital interventions has been proven in randomized controlled trials, findings from routine care are less clear. Low adherence rates are common and limit the potential effectiveness. Adherence has been linked to sociodemographic variables and the amount of guidance, but the role of the guide's profession and their work setting has not yet been studied for routine care. METHODS: Routinely collected log data from a digital intervention for depressed patients (iFightDepression tool) were analyzed in an exploratory manner. The sample is a convenience sample from routine care, where guidance is provided by general practitioners (GP), certified psychotherapists (PT) or medical doctors specialized in mental health. Log data from 2184 patients were analyzed and five usage parameters were extracted to measure adherence (first-to-last login, time on tool, number of sessions, workshops completed and minimal dose). Multiple logistic regression was used to analyze relations between the guide's profession and clinical context as well as other covariates and adherence and symptom change on a brief depression questionnaire (PHQ-9). RESULTS: The analyses showed a significant relation of guide profession and adherence. Guidance by PT was associated to the highest adherence scores (reference category). The odds ratios (ORs) of scoring above the median in each usage parameter for patients guided by GPs were 0.50-0.63 (all ps < 0.002) and 0.61-0.80 (p = .002-0.197) for MH. Higher age, initial PHQ-9 score and self-reported diagnosis of depression were also significantly associated with higher adherence scores. In a subsample providing enough data on the PHQ-9 (n = 347), no association of guide profession with symptom reduction was found. Instead, a greater reduction was observed for patients with a higher baseline PHQ-9 (ß = -0. 39, t(341.75) = -8.814, p < .001) and for those who had achieved minimal dose (ß = -2.42, t(340.34) = -4.174, P < .001) and those who had achieved minimal dose and scored high on time on tool (ß = 0.22, t(341.75) = 1.965, P = .050). CONCLUSION: Being guided by PT was associated with the highest adherence. The lowest adherence was observed in patients who were guided by GP. While no association of guide profession and symptom reduction was found in a subsample, greater adherence was associated with symptom reduction.

Intervention Use and Symptom Change With Unguided Internet-Based Cognitive Behavioral Therapy for Depression During the COVID-19 Pandemic: Log Data Analysis of a Convenience Sample.

BACKGROUND: Internet- and mobile-based interventions are most efficacious in the treatment of depression when they involve some form of guidance, but providing guidance requires resources such as trained personnel, who might not always be available (eg, during lockdowns to contain the COVID-19 pandemic). OBJECTIVE: The current analysis focuses on changes in symptoms of depression in a guided sample of patients with depression who registered for an internet-based intervention, the iFightDepression tool, as well as the extent of intervention use, compared to an unguided sample. The objective is to further understand the effects of guidance and adherence on the intervention's potential to induce symptom change. METHODS: Log data from two convenience samples in German routine care were used to assess symptom change after 6-9 weeks of intervention as well as minimal dose (finishing at least two workshops). A linear regression model with changes in Patient Health Questionnaire (PHQ-9) score as a dependent variable and guidance and minimal dose as well as their interaction as independent variables was specified. RESULTS: Data from 1423 people with symptoms of depression (n=940 unguided, 66.1%) were included in the current analysis. In the linear regression model predicting symptom change, a significant interaction of guidance and minimal dose revealed a specifically greater improvement for patients who received guidance and also worked with the intervention content (ß=-1.75, t=-2.37, P=.02), while there was little difference in symptom change due to guidance in the group that did not use the intervention. In this model, the main effect of guidance was only marginally significant (ß=-.53, t=-1.78, P=.08). CONCLUSIONS: Guidance in internet-based interventions for depression is not only an important factor to facilitate adherence, but also seems to further improve results for patients adhering to the intervention compared to those who do the same but without guidance.

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.

Promises and risks of web-based interventions in the treatment of depression
.

Major depression (MD) is a highly prevalent and severe disorder with many patients having no access to efficient treatments such as pharmaco- and psychotherapy. Web-based interventions promise to be a method to provide resource-efficient and widespread access to psychotherapeutic support. Meta-analyses summarizing studies that use face-to-face psychotherapy as a comparator provide evidence for equivalent antidepressant efficacy. Web-based interventions seem to be particularly efficacious when they are accompanied by some form of professional guidance. However, they are also associated with a variety of possible risks (eg, suicidal crises can be overlooked) and unwanted effects (eg, increase in rumination and somatization due to self-monitoring) that are so far under-studied. Although some naturalistic studies yield smaller effect sizes than randomized controlled trials (RCTs), well-designed interventions with adequate guidance have been shown to be successfully integrable into routine care.
.

La depresión mayor (DM) es un trastorno altamente prevalente y grave, con muchos pacientes que no pueden acceder a tratamientos farmacológicos ni psicoterapéuticos eficientes. Las intervenciones basadas en la web prometen constituir un método que facilite un acceso amplio y eficiente para el apoyo psicoterapéutico. Los metanálisis de estudios que emplean la psicoterapia presencial como comparador, entregan evidencia de una eficacia antidepresiva equivalente. Las intervenciones basadas en la web parecen ser especialmente eficaces cuando van acompañadas de alguna forma de orientación profesional. Sin embargo, también están asociadas con una variedad de posibles riesgos (como pasar por alto situaciones con riesgo suicida) y efectos no deseados (como aumento de la rumiación y somatización debido al autocontrol) que hasta la fecha han sido poco estudiados. Aunque algunos estudios naturalísticos producen efectos de menor tamaño que los ensayos controlados randomizados (ECR), se ha demostrado que las intervenciones bien diseñadas con la orientación adecuada se integran exitosamente a la atención de rutina.

De nombreux patients atteints de dépression majeure, maladie sévère à la prévalence élevée, ne bénéficient pas de traitements efficaces, qu'ils soient pharmacologiques ou psychothérapeutiques. Les thérapies à distance ou en ligne se présentent comme des alternatives à l'aide psychothérapeutique, efficaces et accessibles au plus grand nombre. Leur efficacité antidépressive serait équivalente à celle d'une psychothérapie en présentiel selon des métaanalyses regroupant des études comparatives. Les thérapies à distance semblent être encore plus efficaces si elles bénéficient de l'intervention d'un professionnel, quelle qu'en soit la forme. . Cependant, des risques leur sont également associés (comme la négligence d'un risque suicidaire) et les effets indésirables (l'augmentation des ruminations et la somatisation liée à l'auto-surveillance, par exemple), sont encore peu étudiés. La taille d'effet des études observationnelles peut être inférieure à celle des études contrôlées randomisées (ECR) mais, bien conçues et menées par un professionnel compétent, ces thérapies à distance ont trouvé une place efficace en pratique courante.

Efficacy of a Guided Web-Based Self-Management Intervention for Depression or Dysthymia: Randomized Controlled Trial With a 12-Month Follow-Up Using an Active Control Condition.

BACKGROUND: An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention's efficacy. Studies using active controls are rare and have not yielded conclusive results. OBJECTIVE: The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition. METHODS: A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology-self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses. RESULTS: Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95% CI -0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t259=5.804; P<.01). CONCLUSIONS: The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy. TRIAL REGISTRATION: International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323.

GET.HAPPY2 - User perspectives on an internet-based self-management positive psychology intervention among persons with and without depression: Results from a retrospective survey.

OBJECTIVE: Previous research suggests that online positive psychology interventions (PPI) are frequently used by individuals with symptoms of depression. We aimed to investigate differences in the way depressed and nondepressed users react to the content of an existing online PPI, originally designed for the general public. METHOD: In a retrospective online survey, we assessed discontinuation parameters, aspects of satisfaction with the program, and negative reactions among users of an online PPI. RESULTS: Bivariate and multivariate analyses showed that, overall, reactions between depressed and nondepressed individuals were similar. Differences were observed concerning reasons for using and for discontinuing the program, the perception of exercises, and negative reactions. CONCLUSIONS: Although satisfaction with the program was high, it did not seem to fully meet users' expectations and might be more difficult to complete during episodes of depression. Implications of this study for the adaptation of online PPIs addressing depressed individuals are discussed.

Efficacy of an internet-based self-management intervention for depression or dysthymia - a study protocol of an RCT using an active control condition.

BACKGROUND: The treatment of major depressive disorder, a highly prevalent disorder associated with pronounced burden, is a large challenge to healthcare systems worldwide. Internet based self-management interventions seem to be a cost effective way to complement the treatment of depressed patients, but the accumulating evidence is mainly based on the comparison to waitlist controls and treatment as usual, which might lead to an overestimation of effects. Furthermore, studies assessing long-term effects and possible negative outcomes are still rare. METHODS/DESIGN: The proposed study evaluates the efficacy of the German version of the iFightDepression® tool in comparison to an active control condition. A total of 360 patients with mild to moderate depressive symptoms are included into a two-armed randomized controlled trial. They receive one of two six week interventions; either the iFightDepression® tool or progressive muscle relaxation serving as the control condition. Both intervention groups receive information material, weekly tasks via the internet and regular phone calls as part of the intervention. The primary outcome is change in depressive symptoms after the intervention period, as measured with the Inventory of Depressive Symptomatology. Satisfaction with the program, usability, changes in perceived quality of life, and possible negative effects are assessed as secondary outcomes. DISCUSSION: This study represents the first randomized controlled trial on the iFightDepression® self-management tool in its German version, aiming at efficacy, but also at providing new insights into so far understudied aspects of E-mental health programs, namely the specificity of the treatment effect compared to an active control condition, it's continuity over a time course of 12 months, and possible negative effects of these internet based interventions. TRIAL REGISTRATION: International trial-registration took place through the "international clinical trials registry platform" (WHO) with the secondary ID 080-15-09032015. German Clinical Trial Registration: DRKS00009323 (DRKS.de, registered on 25 February 2016).

GET.HAPPY - Acceptance of an internet-based self-management positive psychology intervention for adult primary care patients with mild and moderate depression or dysthymia: A pilot study.

INTRODUCTION: A growing number of internet interventions have been shown to help in alleviating symptoms of depression. So far, only little research has focused on other methods than CBT. The present study aimed to investigate the level of satisfaction with a positive psychology online training among patients with mild and moderate depression or dysthymia. Secondary outcome measures included changes in symptom severity, health related quality of life, and negative effects. METHODS: A total of 81 participants were allocated to the intervention. They were asked to complete online questionnaires and were called by one of the study psychologists at baseline, at post-treatment, and at follow-up (3 months after completion of the intervention). Shorter questionnaires were administered after each module. RESULTS: Overall satisfaction was promising. While participants seemed to be very satisfied with many aspects of the program itself, they were slightly less satisfied with its impact on the problems they sought to solve. Overall, negative effects attributed to the program were small with one exception. At post-treatment, 22.6% of the participants felt that they or their problems were not taken seriously by the program. Symptom severity decreased over time with mild to moderate effect sizes. There was a moderate increase in satisfaction with mental health at both post-treatment and follow-up. CONCLUSIONS: The online program investigated here may be a useful resource-oriented addition to the standard treatment of depression.