Effectiveness of an Ecological Momentary Emotion Regulation Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Valence-Specific Ecological Momentary Intervention.
- Who it may be relevant to
- Registry conditions: Depressive Disorder, Major, Persistent Depressive Disorder, Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial
Overview
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.
Interventions
- 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 p
Primary outcome measures
- Emotion Regulation Ability (Positive, Negative Emotions) [Time frame: 0 weeks, 3 weeks]
- Emotion Regulation Self-Efficacy for Positive and Negative Emotions [Time frame: 0 weeks, 3 weeks]
Secondary outcome measures (4)
- Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts [Time frame: 0 weeks, 3 weeks]
- Depressive Symptoms [Time frame: 0 weeks, 3 weeks]
- Positive and Negative Affect [Time frame: 0 weeks, 3 weeks]
- Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions [Time frame: 0 weeks, 3 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg U — Heidelberg
Publications
- Park LE, Fujita K, Naragon-Gainey K, Radsvick TM, Jung HY, Xia J, Ward DE, Paravati E, Weng J, Italiano A, Valvo A. Happiness-To enjoy now or later? Consequences of delaying happiness and living in the moment beliefs. Emotion. 2023 Feb;23(1):138-162. doi: 10.1037/emo0000850. Epub 2021 Nov 15. PMID 34780240
- Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21. PMID 28730850
- Llera SJ, Newman MG. Development and validation of two measures of emotional contrast avoidance: The contrast avoidance questionnaires. J Anxiety Disord. 2017 Jun;49:114-127. doi: 10.1016/j.janxdis.2017.04.008. Epub 2017 Apr 28. PMID 28500921
- Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. PMID 25831962
- Roth M, Altmann T. A Comparison of the Predictive Validity of Self-Esteem Level and Directly Measured Self-Esteem Stability in the Temporal Prediction of Psychological Distress. Front Psychol. 2020 Jul 24;11:1770. doi: 10.3389/fpsyg.2020.01770. eCollection 2020. PMID 32849049
- Becerra R, Preece DA, Gross JJ. Assessing beliefs about emotions: Development and validation of the Emotion Beliefs Questionnaire. PLoS One. 2020 Apr 14;15(4):e0231395. doi: 10.1371/journal.pone.0231395. eCollection 2020. PMID 32287328
- Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13. PMID 16367493
- Joshanloo M, Lepshokova ZK, Panyusheva T, Natalia A, Poon WC, Yeung, VWL, ... & Jiang DY. Cross-cultural validation of Fear of Happiness Scale across 14 national groups. Journal of Cross-Cultural Psychology. 2014; 45(2): 246-264.
Identifiers
NCT: NCT06311136 · PEAK