Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy
2021年4月26日 更新者：Verena Zimmermann、Heidelberg University
Depressive Symptoms and Emotion Regulation Following Outpatient Cognitive Behavioral Therapy for Depression: a Longitudinal Study
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.
研究概览
地位
招聘中
条件
研究类型
观察性的
注册 (预期的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Verena Zimmermann, M.Sc.
- 电话号码：+49 6221 547295
- 邮箱：verena.zimmermann@psychologie.uni-heidelberg.de
研究联系人备份
- 姓名：Christina Timm, M.Sc.
- 电话号码：+49 6221 547715
- 邮箱：christina.timm@psychologie.uni-heidelberg.de
学习地点
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-
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Heidelberg、德国、69117
- 招聘中
- Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University
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接触：
- Verena Zimmermann, M.Sc.
- 电话号码：+49 6221 547295
- 邮箱：verena.zimmermann@psychologie.uni-heidelberg.de
-
接触：
- Christina Timm, M.Sc.
- 电话号码：+49 6221 547715
- 邮箱：christina.timm@psychologie.uni-heidelberg.de
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Individuals who have recently completed outpatient cognitive behavioral therapy for depression
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in ecological momentary assessment scores
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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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).
|
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the mental disorders diagnosed with the Structured Clinical Interview for DSM-5 (SCID-5)
大体时间：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
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0, 6, 12, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the score on the Beck Depression Inventory-II (BDI-II)
大体时间：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
|
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the score on the WHO (Five) Well-Being Index (WHO-5)
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the score on the German version of the WHO (Five) Well-Being Index
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the scores on the Brief-Symptom-Checklist (BSCL)
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the German short form of the Symptom Checklist-90-Revised
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
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Change in the scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the German version of the Center for Epidemiologic Studies Depression Scale
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the Difficulties in Emotion Regulation Scale (DERS)
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the German version of the Difficulties in Emotion Regulation Scale
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (HFERST)
大体时间：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)
|
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the scores on the Questions on Life Satisfaction (FLZM)
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the Questions on Life Satisfaction (German Questionnaire)
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
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Change in the scores on the Revised UCLA Loneliness Scale
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the German version of the Revised UCLA Loneliness Scale
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the Rosenberg's Self-Esteem Scale
大体时间：0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the revised version of the German adaptation of Rosenberg's Self-Esteem Scale
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Verena Zimmermann, M.Sc.、Department of Clinical Psychology and Psychotherapy, Heidelberg University
- 首席研究员：Christina Timm, M.Sc.、Department of Clinical Psychology and Psychotherapy, Heidelberg University
- 首席研究员：Annemarie Miano, PhD、Department of Clinical Psychology and Psychotherapy, Heidelberg University
- 首席研究员：Sven Barnow, Prof.、Department of Clinical Psychology and Psychotherapy, Heidelberg University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Beck AT, Steer RA, Brown GK. Beck depression inventory - second edition. Manual. San Antonio, TX: Psychological Corporation, 1996.
- Beesdo-Baum K, Zaudig M, Wittchen H-U. SCID-5-CV. Strukturiertes klinisches Interview für DSM-5®-Störungen - klinische Version. Deutsche Bearbeitung des structured clinical interview for DSM-5® disorders - clinician version von Michael B. First, Janet B.W. Williams, Rhonda S. Karg, Robert L. Spitzer. Göttingen: Hogrefe Verlag, 2019.
- Derogatis, LR. SCL-90-R: Administration, scoring, and procedures manual. Baltimore: Clinical Psychometric Research, 1977.
- Döring N, Bortz J. Psychometrische Einsamkeitsforschung: deutsche Neukonstruktion der UCLA Loneliness Scale. Diagnostica 39(3): 224-239, 1993.
- Ehring T. Übersetzung und Validierung dreier Instrumente zur Erfassung von Merkmalen der Emotionsregulation [Translation and validation of three instruments for the assessment of characteristics of emotion regulation. In preparation.
- First MB, Williams JBW, Karg RS, Spitzer RL. Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). Arlington, VA: American Psychiatric Association, 2016.
- Franke GH. BSCL. Brief-Symptom-Checklist. Göttingen: Hogrefe Verlag, 2012.
- Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment 26(1): 41-54, 2004.
- Hautzinger M, Bailer M, Hofmeister D, Keller F. Allgemeine Depressionsskala. 2., überarbeitete und neu normierte Auflage. Göttingen: Hogrefe Verlag, 2012.
- Hautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar - Manual. Frankfurt am Main: Harcourt Test Services, 2006.
- Henrich G, Herschbach P. Questions on life satisfaction (FLZM) - a short questionnaire for assessing subjective quality of life. European Journal of Psychological Assessment 16(3), 150-159, 2000.
- 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.
- Psychiatric Research Unit, WHO Collaborating Center for Mental Health. WHO (five) well-being index (1998 version). Retrieved from: https://www.psykiatri-regionh.dk/who-5/Documents/WHO5_English.pdf, 1998.
- Psychiatric Research Unit, WHO Collaborating Center for Mental Health. WHO (fünf) - Fragebogen zum Wohlbefinden (Version 1998). Retrieved from: https://www.psykiatri-regionh.dk/who-5/Documents/WHO5_German.pdf, 1998.
- Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 3(1): 385-401, 1977.
- Rosenberg M. Sosciety and the adolescent self-image. Princeton, NJ: Princeton University Press, 1965.
- Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
- von Collani G, Herzberg PY. Eine revidierte Fassung der deutschsprachigen Skala zum Selbstwertgefühl von Rosenberg. Zeitschrift für Differentielle und Diagnostische Psychologie 24(1): 3-7, 2003.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月3日
初级完成 (预期的)
2021年12月1日
研究完成 (预期的)
2021年12月1日
研究注册日期
首次提交
2019年5月27日
首先提交符合 QC 标准的
2019年6月6日
首次发布 (实际的)
2019年6月10日
研究记录更新
最后更新发布 (实际的)
2021年4月27日
上次提交的符合 QC 标准的更新
2021年4月26日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.