Depressive Symptoms and Emotion Regulation Following Outpatient Cognitive Behavioral Therapy for Depression: a Longitudinal Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the score on the Beck Depression Inventory-II (BDI-II)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in the score on the Beck Depression Inventory-II (BDI-II)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
次要结局
- 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 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 UCLA Loneliness Scale(0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy)
研究者
Verena Zimmermann
Research Associate
Heidelberg University