An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i)

BACKGROUND: Depression treatment might be enhanced by ecological momentary interventions (EMI) based on self-monitoring and person-specific feedback. This study is the first to examine the efficacy of two different EMI modules for depression in routine clinical practice.METHODS: Outpatients starting depression treatment at secondary mental health services (N = 161; MIDS-DEPRESSION = 35.9, s.d. = 10.7; MAGE = 32.8, s.d. = 12.1; 46% male) participated in a pragmatic randomized controlled trial with three arms. Two experimental groups engaged in 28 days of systematic self-monitoring (5 times per day), and received weekly feedback on either positive affect and activities (Do-module) or negative affect and thinking patterns (Think-module). The control group received no additional intervention. Participants completed questionnaires on depressive symptoms (primary outcome), social functioning, and empowerment before and after the intervention period, and at four measurements during a 6-month follow-up period.RESULTS: Of the 90 (out of 110) participants who completed the intervention, 86% would recommend it. However, the experimental groups did not show significantly more or faster changes over time than the control group in terms of depressive symptoms, social functioning, and empowerment. Furthermore, the trajectories of the two EMI modules were very similar.CONCLUSIONS: We did not find statistical evidence that this type of EMI augments the efficacy of regular depression treatment, regardless of module content. We cannot rule out that EMIs have a positive impact on other domains or provide a more efficient way of delivering care. Nonetheless, EMI's promise of effectiveness has not materialized yet.</p

Patients' experience of an ecological momentary intervention involving self-monitoring and personalized feedback for depression

Experts in clinical mental health research count on personalized approaches based on self-monitoring and self-management to improve treatment efficacy in psychiatry. Among other things, researchers expect that Ecological Momentary Interventions (EMI) based on self-monitoring and personalized feedback will reduce depressive symptoms. Clinical trial findings have, however, been conflicting. A recent trial (ZELF-i) investigated whether depression treatment might be enhanced by an add-on EMI with self-monitoring items and feedback focused on positive affect and activities (Do-module) or on negative affect and thinking patterns (Think-module). There was no statistical evidence that this EMI impacted clinical or functional outcomes beyond the effects of regular care, regardless of module content. In apparent contrast, 86% of the participants who completed the intervention indicated they would recommend it to others. In the present study, we used in-depth interviews (n = 20) to better understand the EMI's personal and clinical benefits and downsides. A thematic analysis of the interviews generated six areas of impact with various subthemes. In line with the trial results, few participants reported behavioral changes or symptom improvement over time; the self-assessments mainly amplified momentary mood, in either direction. The most often mentioned benefits were an increase in self-awareness, insight, and self-management (e.g., a stronger sense of control over complaints). Consistently, these domains received the highest ratings in our evaluation questionnaire (n = 89). Furthermore, the EMI instilled a routine into the days of individuals without regular jobs or other activities. Participants reported few downsides. The experiences were rather similar between the two modules. This study suggests that EMI might contribute to health by helping individuals deal with their symptoms, rather than reducing them. Measures on self-awareness, insight, and self-management should be more emphatically involved in future EMI research

Dataset: Self-monitoring and personalized feedback as a tool to boost depression treatment: ZELF-i

Pragmatic randomized controlled trial to study the efficacy of two experience sampling intervention modules for depression. ZELF-i is a multi-site trial designed according to the principles of a pragmatic RCT to allow evaluation of the intervention in real-life care facilities. Details are described below according to the SPIRIT guidelines. Data based on 161 male and female adult patients referred for depressive complaints in the North of the Netherlands. Researchers are advised to first contact the listed contact person for more information about ZELF-i, such as current research projects, available data, and how to get access to ZELF-i data. In short: to apply for ZELF-i data by external users, a research protocol and analysis plan need to be submitted, which will be reviewed by the PIs. Once the application has been approved, applicants will receive a Data Transfer Agreement (DTA). The DTA describes in detail which data is being acquired and the purposes and terms for using them. The release of data starts off when the DTA has been signed by both parties

Dataset: Self-monitoring and personalized feedback as a tool to boost depression treatment: ZELF-i

Pragmatic randomized controlled trial to study the efficacy of two experience sampling intervention modules for depression. ZELF-i is a multi-site trial designed according to the principles of a pragmatic RCT to allow evaluation of the intervention in real-life care facilities. Details are described below according to the SPIRIT guidelines. Data based on 161 male and female adult patients referred for depressive complaints in the North of the Netherlands. Researchers are advised to first contact the listed contact person for more information about ZELF-i, such as current research projects, available data, and how to get access to ZELF-i data. In short: to apply for ZELF-i data by external users, a research protocol and analysis plan need to be submitted, which will be reviewed by the PIs. Once the application has been approved, applicants will receive a Data Transfer Agreement (DTA). The DTA describes in detail which data is being acquired and the purposes and terms for using them. The release of data starts off when the DTA has been signed by both parties