Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Heidelberg University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Emotion Regulation Ability (Positive, Negative Emotions)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
During the treatment phase, both the intervention and monitoring-only control groups use a diary called "Positive Everyday Affect Knowledge". Participants are informed that the diary entries may include instructions for implementing specific emotion regulation strategies in their daily activities. However, this component of the procedure is not characterized explicitly as an intervention. This methodological consideration ensures that differences observed between the groups can be attributed to the intervention itself, rather than to differences in participants' expectations.
Clinical interviews will be conducted blindly.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Emotion Regulation Ability (Positive, Negative Emotions)
Time Frame: 0 weeks, 3 weeks
The Perth Emotion Regulation Competency Inventory (PERCI; Preece al., 2021) consists of 32 items, rated on a 7-point scale (1 = strongly disagree, 4 = neither agree nor disagree, 7 = strongly agree) and measures people's ability to regulate their positive and negative emotions. Two different composite scores can be computed to indicate positive and negative emotion regulation ability (Min = 16, Max = 112 for each score), with higher scores indicating a higher level of difficulty regulating positive or negative emotions.
Emotion Regulation Self-Efficacy for Positive and Negative Emotions
Time Frame: 0 weeks, 3 weeks
The German version of the Regulatory Emotional Self-Efficacy-Revised (RESE-R) Scale (adapted from Caprara et al., 2008) consists of 10 items, rated on a 5-point scale (1 = not at all well to 5 = very well). The scale assesses self-efficacy in expressing positive emotions (4 items, Min = 1, Max = 5) and in managing negative emotions (despondency/distress: 3 Items, anger/irritation: 3 items, Min = 1, Max = 5), with higher scores indicating higher self-efficacy beliefs.
Secondary Outcomes
- Positive and Negative Affect(0 weeks, 3 weeks)
- Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts(0 weeks, 3 weeks)
- Depressive Symptoms(0 weeks, 3 weeks)
- Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions(0 weeks, 3 weeks)
Investigators
Ilka Mueller
Principal Investigator
Heidelberg University