Experienced Burden of and Adherence to Smartphone-Based Ecological Momentary Assessment in Persons with Affective Disorders

(1) Background: The use of smartphone-based ecological momentary assessment (EMA) questionnaires in affective disorder research has rapidly increased. Though, a thorough understanding of experienced burden of and adherence to EMA is crucial in determining the usefulness of EMA. (2) Methods: Persons with current affective disorders (n = 100), remitted persons (n = 190), and healthy controls (n = 94) participated in a smartphone-based EMA two-week monitoring period. Our primary outcomes were (momentary) perceived burden of and adherence to EMA. (3) Results: In the whole sample, lower positive and higher negative affect were associated with slightly higher levels of perceived momentary burden (B = -0.23 [95%CI = -0.27-0.19], B = 0.30 [95%CI = 0.24-0.37], respectively). The persons with current affective disorders reported slightly higher levels of experienced momentary burden (Mdn = 1.98 [IQR = 1.28-2.57]), than the remitted persons (Mdn = 1.64 [IQR = 1.11-2.24]) and healthy controls (Mdn = 1.28 [IQR = 1.04-1.92]). Nevertheless, the persons with current affective disorders still showed very high adherence rates (Mdn = 94.3% [IQR = 87.9-97.1]), at rates on a par with the remitted persons (Mdn = 94.3% [IQR = 90.0-97.1]) and healthy controls (Mdn = 94.3% [IQR = 90.0-98.6]). (4) Discussion: Frequent momentary questionnaires of mental well-being are slightly more burdensome to the persons with current affective disorders, but this does not seem to have a negative impact on adherence. Their high rate of adherence to EMA-which was similar to that in remitted persons and healthy controls -suggests that it is feasible to apply (short-duration) EMA

Towards an Implementation-STakeholder Engagement Model (I-STEM) for improving health and social care services

BACKGROUND: The implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation-STakeholder Engagement Model (I-STEM) in the context of an international, large-scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I-STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process. METHODS: In-depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet-based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first- and third-generation Grounded Theory, including constant comparative method. RESULTS: We conducted 55 interviews and observed 19 implementation-related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I-STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes. CONCLUSION: The I-STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I-STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities. PATIENT OR PUBLIC CONTRIBUTION: Patient contribution to ImpleMentAll trial was facilitated by GAMIAN-Europe at all stages-from grant development to dissemination. GAMIAN-Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN-Europe was involved in pilot testing the ItFits-toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits-toolkit. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018

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

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

How is tailored implementation undertaken using a self-guided toolkit? Qualitative study of the ItFits-toolkit in the ImpleMentAll project

BackgroundThe process of tailored implementation is ill-defined and under-explored. The ItFits-toolkit was developed and subsequently tested as a self-guided online platform to facilitate implementation of tailored strategies for internet-based cognitive behavioural therapy (iCBT) services. In ImpleMentAll, ItFits-toolkit had a small but positive effect on the primary outcome of iCBT normalisation. This paper investigates, from a qualitative perspective, how implementation teams developed and undertook tailored implementation using the toolkit within the trial.MethodsImplementation teams in thirteen sites from nine countries (Europe and Australia) used the ItFits-toolkit for six months minimum, consistent with the trial protocol. A qualitative process evaluation was conducted. Descriptive data regarding goals, barriers, strategies, and implementation plans collected within the toolkit informed qualitative data collection in real time. Qualitative data included remote longitudinal interviews (n = 55) with implementation team members (n = 30) and observations of support calls (n = 19) with study sites. Qualitative data were analysed thematically, using a team-based approach.ResultsImplementation teams developed and executed tailored implementation projects across all steps in the toolkit process. Working in a structured way but with room for flexibility, decisions were shaped by team members' ideas and goals, iterative stakeholder engagement, internal and external influences, and the context of the ImpleMentAll project. Although teams reported some positive impacts of their projects, 'time', both for undertaking the work, and for seeing project impacts, was described as a key factor in decisions about implementation strategies and assessments of success.ConclusionThis study responds directly to McHugh et al.'s (2022) call for empirical description of what implementation tailoring looks like in action, in service settings. Self-guided facilitation of tailored implementation enables implementers in service settings to undertake tailoring within their organisations. Implementation tailoring takes considerable time and involves detailed work but can be supported through the provision of implementation science informed guidance and materials, iterative and ongoing stakeholder engagement, and working reflectively in response to external influencing factors. Directions for advancement of tailored implementation are suggested

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

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

Measurement innovation: studies on smartphone-based ecological momentary assessment in depression

In Chapter 2, experienced burden of and adherence to a short-duration monitoring period was examined in a cohort of participants suffering an affective disorder (n=100), remitted persons (n=190) and healthy controls (n=94). Participants were invited to complete five EMAs a day, for fourteen days. The perceived burden at the moment of assessing (“momentary burden”) was slightly higher when momentary mood was worse. Nevertheless, momentary burden remained stable over the course of the monitoring period. Moreover, when asked to evaluate the overall monitoring period in retrospect, no inter-group differences were identified. In terms of adherence rates, the participants with affective disorders showed very high adherence rates (94%), with a rate on a par with the other two groups. The results suggest that it is feasible to apply short-duration and intensive EMA monitoring in a cohort of persons suffering from an affective disorder. Though, the participants were selected from the NESDA cohort, and the participants had been participating in the NESDA study for over nine years. As such it can be assumed that the NESDA-participants are highly motivated. In Chapter 3 and 4, we examined different distinctive profiles in mood dynamics among a sample suffering from subclinical depression who were recruited in the general population (chapter 3) and MDD patients during their first week of treatment (chapter 4). The analyses revealed two profiles in de first sample, and four profiles in Chapter 4’s sample. The profiles differed in terms of average mood and mood variability, but not emotional inertia. Even though the profiles, in both samples, different substantially in sample size, the studies provided us with initial insights in the heterogeneity of average mood and mood variability, but not emotional inertia in both subclinical depressed persons and MDD patients. In Chapter 5, building further on Chapter 4, posited a first attempt in examining the utility of the smartphone-based EMA-derived profiles of mood dynamics as predictor for treatment responsiveness during and after treatment for MDD. Treatment outcome was operationalized by a decrease in depression severity (assessed pre-treatment, at three-, six- and twelve-months). The results of this study suggested that smartphone-based EMA-derived profiles of average mood and mood variability could potentially distill patients who have a more favorable prognosis following treatment for depression. Caution is needed when interpreting our results, amongst others as some of the profiles derived in Chapter 4 referred to relatively small number of patients, implying large standard errors. The purpose of the study in Chapter 6 was to examine the assumed temporal associations in the theoretical framework of behavioral activation (BA) during blended cognitive behavioral therapy (CBT). The smartphone-based EMA included weekly reports of 240 patients on their levels of engaging in pleasant activities, on the perceived pleasure as a result of these activities and their mood. The analyses revealed positive cross-sectional relations between activation, experienced pleasure and mood. In other words, in weeks a patient engaged in more pleasant activities, they also reported experiencing more pleasure. In weeks a patient experienced more pleasure, they also reported a better mood. In weeks a patient reported a better mood, they also engaged in more activities. However, the analyses did not reveal any statistically significant temporal (cross-lagged) relations. The results of this study were partly in line with the theory of BA, but no conclusions could be drawn about possible temporal precedence or causality