Treatment of Depression With Mindfulness, Acceptance and Commitment

赞助:

合作者:

信息的提供 (责任方):

Peter Tonn，Neuropsychiatrischen Zentrums Hamburg-Altona

追踪信息

首次提交日期 ^ICMJE

August 23, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

November 2018

预计主要完成日期

December 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Depression - Patient Health Questionnaire-9[ Time Frame: Measurement of PHQ-Data 3 months after inclusion of participant ]

Measurement of changes of depressive Symptoms, so called PHQ-9. There will be a measure of the total score, range from 9 to 36, pathological in sense of depression will be any score above 15. There is only one measurement scale (PHQ-9) with nine items, no other measurements or different units in the PHQ-9.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Quality of Life - European Quality 5 Dimensions on 3 Levels[ Time Frame: Measurement of QoL 3 months after inclusion of participant ]
Measurements of changes of Quality of life (EQ-5D 3L), there will be a measure of three dimensions of life quality in scores 0-10, the total is a sum and will be added from the single measurements. There is a range from 0-30, no "critical number" is defined, only the sum will be used for interpretation. A higher score represents a better result /state
Anxiety - Generalized Anxiety Disorder[ Time Frame: Measurement of Generalized Anxiety 3 months after inclusion of participant ]
Measurements of changes of Anxiety (GAD 7), there are 7 questions to check anxiety, the range is from 7-28, pathological in sense of manifest anxiety disorder is a sum above 9 plus the key-question.A lower score represents a better result/ state.
Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)[ Time Frame: Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant ]
Measurements of changes of Mindfulness, Acceptance and Commitment, that is a measurement with 8 questions, range from 0-32, only the sum will be noticed, no "critics score" is published yet. A higher score represents a better result/ state.

描述性信息

简略标题 ^ICMJE

Treatment of Depression With Mindfulness, Acceptance and Commitment

正式标题 ^ICMJE

Mindfulness, Acceptance and Commitment Combined in Cognitive Behavioral Group Therapy (MAC-CBT®) for Patients With Depression

简要概况

Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients

详细说明

In this study, a randomized trial is conducted in which the participants are allocated to two different care services (MAC-CBT® vs. progressive muscle relaxation). Participants are patients with depression who have been made aware of the group therapy by their treating physicians or psychotherapists or who have read the advertising in waiting areas or on the investigators homepage. An extensive psychometric survey will be conducted at the start of the study in an interview session with a psychotherapist, who also judges if the participants are able to participate in a therapy group. The MAC-CBT® group receives an eight-session group therapy, in which the aspects of mindfulness, acceptance and commitment are taught in detail. The control group will receive an eight-session treatment with progressive muscle relaxation. Input and output results are determined using validated survey instruments. In addition, the investigators will check the data for moderating variables (e.g. age, gender, previous treatments...).

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: One group with new treatment, one group with known and defined treatment
盲法: Interventional
盲法描述:The participants don't know in which of the both arms they are, the outcome assessor don't know which participant of which study-arm he/she calculate
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Behavioral: Mindfulness, Acceptance and Commitment-Therapy
Psychotherapeutic intervention to treat depressive patients with special exercises and education to be mindful, to accept situations and behaviors and to commit with the situation or the possibility to change.
Behavioral: Jacobson
Relaxation treatment in technique of Jacobson

研究工具

Active Comparator: New Treatment
The patients will be treated with psychological group treatment for 8 Sessions with focus on mindfulness, acceptance and commitment in a special adapted treatment process.This will be called "Mindfulness, Acceptance and Commitment-Therapy for depressive Patients".
Sham Comparator: Known Treatment
The participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique".

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

120

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

March 2020

预计主要完成日期

December 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Depressive Disorder Exclusion Criteria: - Somatic disorder - psychotic disorder - personality disorder

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：70 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Peter Tonn，Neuropsychiatrischen Zentrums Hamburg-Altona

研究赞助商 ^ICMJE

Neuropsychiatrischen Zentrums Hamburg-Altona

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Peter Tonn, MD Managing Director

PRS 账户

Neuropsychiatrischen Zentrums Hamburg-Altona

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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