Effectiveness of an Ecological Momentary Emotion Regulation Intervention

NCT06311136 | Recruiting

• 1 other identifier: PEAK
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major; Persistent Depressive Disorder; Healthy

Keywords

Emotion Beliefs; Emotional Regulation; Positive Emotions; Affective Symptoms; Ecological Momentary Assessment; Internet-Based Intervention; Depression

Outcome Measures

Primary Outcomes (2)

• Emotion Regulation Ability (Positive, Negative Emotions)

  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.

  0 weeks, 3 weeks

• Emotion Regulation Self-Efficacy for Positive and Negative Emotions

  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.

  0 weeks, 3 weeks

Secondary Outcomes (4)

• Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts

  0 weeks, 3 weeks

• Depressive Symptoms

  0 weeks, 3 weeks

• Positive and Negative Affect

  0 weeks, 3 weeks

• Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions

  0 weeks, 3 weeks

Other Outcomes (10)

• Well-being

  0 weeks, 3 weeks

• Life Satisfaction

  0 weeks, 3 weeks

• Emotion Beliefs about Positive Emotions (Delay Happiness, Living in the Moment)

  0 weeks, 3 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants complete a valence-specific ecological momentary intervention twice daily over 14 consecutive days. The ecological momentary intervention is presented as the "Positive Everyday Affect Knowledge" (PEAK) diary and includes valence-specific emotion regulation strategy instructions. Participants receive reminders to complete surveys on their strongest emotions since the last assessment. Depending on the valence of this emotion, they receive instructions on how to use the strategy savoring (for positive emotions) or reappraisal (for negative emotions).

Behavioral: Valence-Specific Ecological Momentary Intervention

Monitoring-only control group

NO INTERVENTION

Participants complete a valence-specific ecological momentary assessment twice daily over 14 consecutive days. The ecological momentary assessment is presented as the "Positive Everyday Affect Knowledge" (PEAK) diary, and only involves monitoring participants' emotional experiences and regulation. Participants receive reminders to complete surveys on their strongest emotions since the last assessment. Depending on the valence of this emotion (positive versus negative), they are asked about their emotion regulation strategies.

Interventions

Valence-Specific Ecological Momentary Intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University

Heidelberg, 69117, Germany

RECRUITING

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• Preece DA, Becerra R, Sauer-Zavala S, Boyes M, McEvoy P, Villanueva C, Ibonie S, Gruber J, Hasking P, Gross JJ. Assessing Emotion Regulation Ability for Negative and Positive Emotions: Psychometrics of the Perth Emotion Regulation Competency Inventory in United States Adults. J Affect Disord. 2021 Nov 1;294:558-567. doi: 10.1016/j.jad.2021.07.055. Epub 2021 Jul 16.

  PMID: 34330052 BACKGROUND

• Caprara GV, Di Giunta L, Eisenberg N, Gerbino M, Pastorelli C, Tramontano C. Assessing regulatory emotional self-efficacy in three countries. Psychol Assess. 2008 Sep;20(3):227-37. doi: 10.1037/1040-3590.20.3.227.

  PMID: 18778159 BACKGROUND

• Watson D, Clark LA. The PANAS-X: Manual for the Positive and Negative Affect Schedule - Expanded Form [Unpublished Manuscript] University of Iowa. 1994.

  BACKGROUND

• Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.

  PMID: 24402217 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Niessen D, Schmidt I, Groskurth K, Rammstedt B, Lechner CM. The Internal-External Locus of Control Short Scale-4 (IE-4): A comprehensive validation of the English-language adaptation. PLoS One. 2022 Jul 11;17(7):e0271289. doi: 10.1371/journal.pone.0271289. eCollection 2022.

  PMID: 35816496 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Emotional Regulation; Affective Symptoms; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Ilka Mueller, M.Sc.

  Department of Psychology, Heidelberg University

  PRINCIPAL INVESTIGATOR

• Luise Pruessner, M.Sc.

  Department of Psychology, Heidelberg University

  PRINCIPAL INVESTIGATOR

• Steffen Hartmann, M.Sc.

  Department of Psychology, Heidelberg University

  PRINCIPAL INVESTIGATOR

• Sven Barnow, PhD

  Department of Psychology, Heidelberg University

  STUDY CHAIR

Central Study Contacts

Ilka Mueller, M.Sc.

CONTACT

+496221/547362; ilka.mueller@psychologie.uni-heidelberg.de

Luise Pruessner, M.Sc.

CONTACT

+496221/547282; luise.pruessner@psychologie.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial with an Intervention Group and a Control Group without an intervention.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: January 12, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Data will be made available after the publication of the study results.
• Access Criteria: Open access, available upon request.

Locations

DE (1)