Clinical trial NCT06311136: Effectiveness of an Ecological Momentary Emotion Regulation Intervention
Official title: Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder, Major
Persistent Depressive Disorder
Healthy
Keywords: Emotion Beliefs
Emotional Regulation
Positive Emotions
Affective Symptoms
Ecological Momentary Assessment
Internet-Based Intervention
Depression
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with an Intervention Group and a Control Group without an intervention.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Online consent for participation
* Adequate proficiency in the German language, encompassing both reading and comprehension skills
* Ownership of a smartphone, compatible with either Android or iOS operating systems, and access to the Internet

For individuals in the clinical group with current depressive disorders:

* Currently meeting the DSM-5 criteria for a mild or moderate major depressive episode, or persistent depressive disorder

Exclusion Criteria:

* Current severe substance use disorder
* Acute suicidality
* Current severe major depressive episode
* Lifetime bipolar disorder
* Lifetime psychotic disorders

For the control group, additional exclusion criteria include:

* Meeting the DSM-5 criteria for a major depressive episode within the last 12 months
* History of severe major depressive episodes
* Recurrent depressive disorder
* History of persistent depressive disorder
* Current treatment (psychotherapy, pharmacotherapy) for depressive symptoms

Primary outcomes:
measure: Emotion Regulation Ability (Positive, Negative Emotions)
timeFrame: 0 weeks, 3 weeks
measure: Emotion Regulation Self-Efficacy for Positive and Negative Emotions
timeFrame: 0 weeks, 3 weeks
Secondary outcomes:
measure: Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts
timeFrame: 0 weeks, 3 weeks
measure: Depressive Symptoms
timeFrame: 0 weeks, 3 weeks
measure: Positive and Negative Affect
timeFrame: 0 weeks, 3 weeks
measure: Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions
timeFrame: 0 weeks, 3 weeks
Other outcomes:
measure: Well-being
timeFrame: 0 weeks, 3 weeks
measure: Life Satisfaction
timeFrame: 0 weeks, 3 weeks
measure: Emotion Beliefs about Positive Emotions (Delay Happiness, Living in the Moment)
timeFrame: 0 weeks, 3 weeks
measure: Emotion Beliefs about Positive Emotions (Fear of Happiness)
timeFrame: 0 weeks, 3 weeks
measure: Negative Emotional Contrast Avoidance
timeFrame: 0 weeks, 3 weeks
measure: Emotion Regulation Strategy Use
timeFrame: 0 weeks, 3 weeks
measure: Self-Esteem
timeFrame: 0 weeks, 3 weeks
measure: Locus of Control
timeFrame: 0 weeks, 3 weeks
measure: Controllability Beliefs about Emotions
timeFrame: 0 weeks, 3 weeks
measure: Anxiety Symptoms
timeFrame: 0 weeks, 3 weeks
Locations:
city: Heidelberg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University
Study officials:
affiliation: Department of Psychology, Heidelberg University
name: Ilka Mueller, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Luise Pruessner, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Steffen Hartmann, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Sven Barnow, PhD
role: STUDY_CHAIR
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