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临床试验/NCT04159285
NCT04159285已完成不适用

Augmenting and Sustaining Electroconvulsive Therapy (ECT) Treatment Effects by Group Cognitive Behavioural Therapy (CBT) in Unipolar Depressed Patients

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年1月5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
16
试验地点
1
主要终点
Clinican-Rated Depressive Symptoms at treatment end

研究概览

简要总结

This study aims to investigate effectiveness and feasability of a 15-week group psychotherapeutic intervention as continuation treatment after electroconvulsive therapy in severely depressed patients. Feasibility and acceptance of the half-open manualized CBT intervention are assessed. Depressive symptoms, quality of life and emotion regulation skills will be assessed before ECT treatment, before and after the 15-week group CBT intervention and at a 6 months follow-up after treatment end and compared to depressed patients treated with ECT who did not partake in group CBT. Moreover, patients will attend two indidivual pre-group sessions with one of the group therapist and one individual post-group session

详细描述

While Electroconvulsive therapy (ECT) is a highly effective anti-depressant treatment, a relevant number of patients experience recurrence of depressive episodes within 6 months.

One previous study suggested that ECT treatment effects can be effectively sustained by group CBT (Cognitive Behavioral Therapy, Brakemeier et a. 2014). This previous implementation used a closed CBT-group set-up that implicated a longer waiting period for patients after finishing the acute ECT and did not investigate whether patients who did not respond to ECT could sufficiently profit from group CBT. In order to suit the complex needs of patients in a natural clinical setting, the present study aims to investigate the feasibility and effectiveness of a half-open continuous group CBT (named EffECtive 2.0) as continuation treatment for all ECT patients regardless of remission status after ECT.

This prospective study will recruit a total of 30 patients who concluded treatment with right-unilateral ultra-brief ECT for depression. Patients self-allocate to the group that is offered in addition to continuation treatment as usual (TAU, e.g. pharmacological treatment, continuation ECT, individual psychotherapy). ECT completers who choose not to partake in the group for practical concerns or lack of interest and receive treatment as usual are recruited as a control group.

The primary outcome measure is the change depression severity, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes are quality of life assessed with the short-version of the WHO quality of life questionnaire (WHOQOL-Bref) and emotion regulation as assessed with cognitive emotion regulation questionnaire (CERQ). These measures will be assessed before, during, immediately after acute ECT and six and 12 months into continuation therapy.

It is hypothesized that a group CBT as add-on treatment to TAU will lead to more favorable outcomes concerning depression severity, quality of life and emotion regulation.

研究设计

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

入排标准

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

入选标准

  • •treated with ECT for major depression

排除标准

  • •severe comorbid personality disorders
  • •principal diagnosis other than depression

研究组 & 干预措施

Group CBT

Experimental

15-week group CBT with a focus on improvement of social interactions by cognitive re-modelling and role plays. Patients may simultaneously receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication.

干预措施: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients (Behavioral)

Treatment as Usual

Experimental

Patients may receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication.

干预措施: Treatment as usual (Other)

Group CBT

Experimental

15-week group CBT with a focus on improvement of social interactions by cognitive re-modelling and role plays. Patients may simultaneously receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication.

干预措施: Treatment as usual (Other)

结局指标

主要结局

Clinican-Rated Depressive Symptoms at treatment end

时间窗: End of group therapy treatment (~6 months after ECT treatment)

MADRS

Clinican-Rated Depressive Symptoms at follow-up

时间窗: 6 months after end of group therapy

MADRS

次要结局

  • Quality of life at follow-up(6 months after end of group therapy)
  • Self-Reported Depressive Symptoms at follow up(6 months after end of group therapy)
  • Self-Reported Depressive Symptoms at treatment end(End of group therapy treatment (~6 months after ECT treatment))
  • Emotion regulation capacities at follow-up(6 months after end of group therapy)

研究者

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

Simone Grimm

Prof. Dr.rer.nat. Simone Grimm

Charite University, Berlin, Germany

研究点 (1)

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