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临床试验/NCT03080025
NCT03080025已完成不适用

The Effects of a Cognitively-based Compassion Training on Health and Social Interaction in Depressed Patients and Their Partners

Heidelberg University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Eye gaze patterns

研究概览

简要总结

The purpose of this study is to determine how a CBCT® (Cognitively Based Compassion-Training) for couples affect aspects of health and especially social interactions in depressed female patients and their romantic partners. compare healthy and depressed couples during an instructed positive real-time social interaction in the laboratory.

Furthermore the investigators aim to examine how social behavior and psychobiological indicators of health during real-time social interaction in the laboratory might be improved through CBCT® for couples.

详细描述

Objects:

Will a CBCT® (Cognitively Based Compassion-Training) for couples reduce the depressive symptomatic and the partners´ burden as well as improve behavioral, endocrine, physiological and immune responses during a real time social interaction in the laboratory.

Do couples with a depressed female partner differ from healthy control couples in behavioral, endocrine, physiological and immune responses during a instructed positive real-time social interaction in a laboratory setting?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •General inclusion criteria:
  • •being in a heterosexual relationship for two years or more
  • •agreement to participate in the study
  • •recurrent depression (ICD-10 F33.0 or F33.1, depressed females of the patient couples only)
  • •agreement of the patient couples to be randomized into the two treatment arms
  • •no mental disorders (healthy control group only)

排除标准

  • •severe acute and chronic psychological ( suicidal tendency, acute affective bipolar disorders) or physical disorder (chronic diseases, severe diseases such as endocrinological, neurological, nephrological or hepatic disorders)
  • •being pregnant
  • •heavy smoking (more than 20 cigarettes daily) or alcohol abuse
  • •substance related abuse and addiction
  • •enrolling current couple therapy
  • •enrolling current individual therapy (except of probatory phase)
  • •enrolling current mindfulness or compassion based group training

研究组 & 干预措施

CBCT® for Couples

Experimental

The CBCT® (Cognitively Based Compassion-Training) for couples (CBCT®-fC) consists of a ten-week training program with a 2h group session weekly and daily home practice based on prerecorded guided mediations (Emory University, Atlanta, USA; Ozawa-de Silva & Negi, 2013). The ten weeks start with an overview and a take-home ideas for continuing practice. Furthermore the first and the 3rd module will be repeated once resulting in a total of ten weeks. Further couple- and dyadic exercises are added.

It focuses on six essential key parts for the development of compassion:

  1. Developing attentional stability and clarity of the mind (Mindfulness)
  2. Cultivating insight into the nature of mental experience
  3. Cultivating self-compassion
  4. Developing impartiality
  5. Developing appreciation and affection for others
  6. Developing empathy and realizing engaged compassion

干预措施: CBCT® (Cognitively Based Compassion-Training) (Behavioral)

Treatment as usual (TAU)

No Intervention

Treatment as usual: Primary care according to guidelines from the S3- and national healthcare guideline "Unipolar Depression" [S3-Leitlinie und Nationale VersorgungsLeitlinie (NVL) Unipolare Depression, Ärztliches Zentrum für Qualität in der Medizin], but excluding current psychotherapy after probatory session.

结局指标

主要结局

Eye gaze patterns

时间窗: 4 weeks after recruitment and 12 weeks after first test

Changes in eye gaze patterns (total fixation time \& fixation count) as behavioural component measured during standardised positive social interaction- pre \& post training.

Circadian variation pattern of heart rate variability

时间窗: 4 weeks after recruitment and 12 weeks after first test

Changes in circadian variation pattern of heart rate variability pre \& post training.

Depressive symptoms

时间窗: 4 weeks after recruitment and 12 weeks after first test

Change in depression score (observer rating Hamilton Depression Rating Scale \[HDRS\], self-rating Becks Depression Inventory \[BDI\]) after CBCT® (Cognitively Based Compassion Training) for couples in comparison to control TAU-group (treatment as usual).

次要结局

  • Analysis of psychometrical self- and observer rating und their correlations(4 weeks after recruitment and 12 weeks after first test)
  • Biopsychological concomitants of depressive disorders(4 weeks after recruitment and 12 weeks after first test)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beate Ditzen

Prof. Dr. phil. Dipl.- Psych. Beate Ditzen

Heidelberg University

研究点 (1)

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