Emotion regulation intervention for depression and healthy individuals
Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial
This study is testing a smartphone program that helps people with mild to moderate depression and healthy individuals learn to manage their emotions better and see if it makes a difference in how they feel.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT06311136 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effectiveness of a smartphone-based emotion regulation intervention targeting both positive and negative emotions in individuals with mild to moderate major depressive disorder and healthy controls. Participants will be randomly assigned to either an intervention group, which receives valence-specific strategies for emotion regulation, or a control group that only monitors their emotions. The study aims to explore how beliefs about emotions influence the selection of regulation strategies and to assess improvements in emotion regulation ability and depressive symptoms. Outcome measures will include self-efficacy and the use of emotion regulation strategies.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with mild to moderate major depressive disorder or persistent depressive disorder, as well as healthy individuals without current depressive disorders.
Not a fit: Patients with severe depressive episodes, acute suicidality, or severe substance use disorders may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could enhance emotion regulation skills and reduce depressive symptoms in affected individuals.
How similar studies have performed: Previous studies have shown promise in using ecological momentary interventions for emotion regulation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg
- Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University — Heidelberg, Germany (Recruiting)
Study contacts
- Principal investigator: Ilka Mueller, M.Sc. — Department of Psychology, Heidelberg University
- Study coordinator: Ilka Mueller, M.Sc.
- Email: ilka.mueller@psychologie.uni-heidelberg.de
- Phone: +496221/547362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.