Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

• Conditions: Depression

• Registration Number: NCT03979963
• Lead Sponsor: Heidelberg University

Brief Summary

This study investigates depressive symptoms and the use of emotion regulation strategies over the course of a two-year period in participants terminating outpatient cognitive behavioral therapy for depression. The main objective of the study is to examine if changes in the use of certain emotion regulation strategies (e.g. reappraisal, rumination) predict depression relapse or changes in depressive symptoms after the completion of outpatient cognitive behavioral therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study Start: 2019-06-03
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age older than 18 years
• regular termination of outpatient cognitive behavioral therapy for depression (or premature termination agreed upon by both the therapist and the patient because of symptom improvement after at least 12 sessions)
• last therapy session not more than two weeks prior to enrollment
• self-reported improvement in depressive symptoms as a result of cognitive behavioral therapy
• possession of a smartphone (operating system: Android or iOS) with Internet access
• possession of a laptop/desktop computer with Internet access
• familiarity with apps and the Internet
• fluency in German language

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Exclusion Criteria

• premature termination of outpatient cognitive behavioral therapy (exception: termination agreed upon by both the therapist and the patient because of symptom improvement)
• BDI-II score ≥ 20
• acute substance use disorder (< 3 months)
• current or past psychotic disorder
• current or past (hypo)manic episode
• acute suicidality
• severe neurological disorder/cerebral damage
• severe physical/medical illness

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the score on the Beck Depression Inventory-II (BDI-II)	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the score on the German version of the Beck Depression Inventory-II
Change in the score on the WHO (Five) Well-Being Index (WHO-5)	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the score on the German version of the WHO (Five) Well-Being Index
Change in ecological momentary assessment scores	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in ecological momentary assessment scores. Data will be collected using the smartphone app EmoTrack2. The app measures emotions experienced, context factors of the emotional experiences, and emotions regulation strategies used (five measurements per day over a period of seven consecutive days).
Change in the mental disorders diagnosed with the Structured Clinical Interview for DSM-5 (SCID-5)	0, 6, 12, and 24 months after completion of cognitive behavioral therapy	Change in the mental disorders diagnosed with the German version of the Structured Clinical Interview for DSM-5
Change in the scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the scores on the German version of the Center for Epidemiologic Studies Depression Scale
Change in the scores on the Difficulties in Emotion Regulation Scale (DERS)	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the scores on the German version of the Difficulties in Emotion Regulation Scale
Change in the scores on the Brief-Symptom-Checklist (BSCL)	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the scores on the German short form of the Symptom Checklist-90-Revised
Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (HFERST)	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (German questionnaire)

Secondary Outcome Measures

Name	Time	Method
Change in the scores on the Questions on Life Satisfaction (FLZM)	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the scores on the Questions on Life Satisfaction (German Questionnaire)
Change in the scores on the Rosenberg's Self-Esteem Scale	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the scores on the revised version of the German adaptation of Rosenberg's Self-Esteem Scale
Change in the scores on the Revised UCLA Loneliness Scale	0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy	Change in the scores on the German version of the Revised UCLA Loneliness Scale

Trial Locations

Locations (1)

Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University; 🇩🇪 Heidelberg, Germany