NCT06311136

Effectiveness of an Ecological Momentary Emotion Regulation Intervention

Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without a current depressive disorder. Participants will be randomly assigned to either the intervention group, receiving a valence-specific emotion regulation intervention in daily life, or a monitoring-only control group. The valence-specific intervention supports the implementation of different emotion regulation strategies based on whether a person is experiencing mainly positive or negative emotions. In contrast, participants in the control group will solely monitor their positive and negative emotions and the strategies used to regulate them. Outcome measures include emotion regulation ability, self-efficacy, and strategy use, depressive symptoms, positive and negative affect, and emotion beliefs (controllability, usefulness). A second aim of the study is to compare beliefs about positive emotions and strategies to regulate them between individuals with and without current depressive disorders. Furthermore, the investigators aim to examine why individuals might choose unfavorable emotion regulation strategies even when feeling good. Therefore, another research question is, how emotion beliefs might explain emotion regulation strategy choice.

Detailed description

Background: Affective disorders, such as depression, have been consistently associated with deficiencies not only in the regulation of negative emotions but also in the maintenance and upregulation of positive emotions. However, the mechanisms underlying emotion regulation deficits in depressive disorders remain inadequately understood. Recently, there has been a growing interest in the role of beliefs about emotions as factors contributing to emotion regulation deficits in psychopathology. In light of this, this study seeks to explore potential differences in beliefs about positive (and negative) emotions between individuals with and without current depressive disorders. Another aim of this study is to examine how these individual differences in emotion beliefs predict the selection of emotion regulation strategies in daily life, particularly in the context of positive emotions. Given the pivotal role that deficits in emotion regulation play in the onset and persistence of depressive disorders, this study aims to investigate whether an ecological momentary intervention, addressing both positive and negative emotion regulation, can effectively improve emotion regulation processes. Recent research suggests that distinct emotion regulation strategies may be effective for positive versus negative emotion regulation. Consequently, this study aims to evaluate the effectiveness of a smartphone-based, valence-specific emotion regulation intervention in individuals with and without current depressive disorders. Method: This study will enlist participants aged between 18 and 65, diagnosed with mild to moderate major depression or persistent depressive disorder, as well as healthy controls without a current depressive disorder. Individuals presenting with a current severe substance use disorder, acute suicidality, an ongoing severe major depressive episode, a history of bipolar disorder, or lifetime psychotic disorders are precluded from participation in both groups. Additional exclusion criteria for participation within the control cohort encompass (a) occurrence of a major depressive episode in the preceding 12 months, (b) history of severe major depressive episodes, (c) diagnosis of recurrent depressive disorder or history of persistent depressive disorder, and (d) ongoing treatment modalities related to a depressive episode, including psychotherapy or pharmacotherapy. Participants will undergo baseline questionnaires before completing four daily smartphone-based assessments over seven consecutive days, evaluating their emotion beliefs, emotion regulation, and emotional outcomes. Participants will be randomly assigned to either the intervention or the monitoring-only control group. Following a four-day break, participants in the intervention group will receive a valence-specific ecological momentary intervention targeting emotion regulation in daily life. During this period, participants will report their emotional experiences twice daily and will be supported in implementing either reappraisal or savoring strategies based on the valence of their current predominant emotion. Participants in the control group will be instructed to complete two daily assessments, monitoring their emotions and the strategies used to regulate them. After an additional four-day break, participants will be invited to complete post-assessment questionnaires capturing emotion regulation ability, self-efficacy and strategy use, depressive symptoms, emotion beliefs (controllability, usefulness), and another week of ecological momentary assessment (four per day), encompassing, among other variables, the use of emotion regulation strategies and the experience of positive and negative emotions. Hypotheses: The valence-specific intervention is hypothesized to enhance emotion regulation ability and self-efficacy, emotional outcomes (depressive symptoms, positive and negative affect), and emotion beliefs (controllability, usefulness) and to increase the application of reappraisal in negative and savoring in positive emotional contexts in daily life. The investigators hypothesize that individuals with current depressive disorders will report more unfavorable beliefs about emotions and higher use of strategies associated with dampening positive emotions compared to controls at baseline. Furthermore, the investigators expect that unfavorable beliefs about positive emotions at baseline (i.e., assuming that positive emotions are harmful) may predict the selection of dampening strategies in the context of positive emotions.

Conditions

• Depressive Disorder, Major
• Persistent Depressive Disorder
• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Valence-Specific Ecological Momentary Intervention	The ecological momentary intervention is designed to enhance participants ability to select and effectively implement emotion regulation strategies fitting to the valence of their current emotions. Specifically, the intervention instructs participants to use the strategy of savoring to amplify their positive emotions, fostering an appreciation for the present moment. Conversely, for the attenuation of negative emotions, the intervention advocates to use the strategy of reappraisal, encouraging participants to reinterpret adverse situations in a more positive or neutral way, thus reducing their emotional impact. This targeted approach ensures that the emotion regulation strategies are not only effective but also contextually appropriate.

Timeline

• Start date: 2024-01-12
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-03-15
• Last updated: 2025-03-27

Locations

1 site across 1 country: Germany