Clinical trial NCT03979963: Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy
Official title: Depressive Symptoms and Emotion Regulation Following Outpatient Cognitive Behavioral Therapy for Depression: a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Keywords: Depression
Emotion Regulation
Cognitive Behavioral Therapy
Ecological Momentary Assessment
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have recently completed outpatient cognitive behavioral therapy for depression

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Change in ecological momentary assessment scores
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the mental disorders diagnosed with the Structured Clinical Interview for DSM-5 (SCID-5)
timeFrame: 0, 6, 12, and 24 months after completion of cognitive behavioral therapy
measure: Change in the score on the Beck Depression Inventory-II (BDI-II)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the score on the WHO (Five) Well-Being Index (WHO-5)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the scores on the Brief-Symptom-Checklist (BSCL)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the scores on the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (HFERST)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
Secondary outcomes:
measure: Change in the scores on the Questions on Life Satisfaction (FLZM)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the scores on the Revised UCLA Loneliness Scale
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
measure: Change in the scores on the Rosenberg's Self-Esteem Scale
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University
Study officials:
affiliation: Department of Clinical Psychology and Psychotherapy, Heidelberg University
name: Verena Zimmermann, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Psychology and Psychotherapy, Heidelberg University
name: Christina Timm, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Psychology and Psychotherapy, Heidelberg University
name: Annemarie Miano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Psychology and Psychotherapy, Heidelberg University
name: Sven Barnow, Prof.
role: PRINCIPAL_INVESTIGATOR
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