Treatment of Depression With Mindfulness, Acceptance and Commitment

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

Detailed Description
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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...).

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

Conditions
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Psychotherapy, Depression

Intervention / Treatment
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* Behavioral: Mindfulness, Acceptance and Commitment-Therapy
* Behavioral: Jacobson


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Depressive Disorder Exclusion Criteria: Somatic disorder psychotic disorder personality disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group with new treatment, one group with known and defined treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: New Treatment<br>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. | Behavioral: Mindfulness, Acceptance and Commitment-Therapy<br>* 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.<br>|
| Sham Comparator: Known Treatment<br>The participants will be treated with a relaxation-treatment, long time established as jacobson muscle relaxing technique. | Behavioral: Jacobson<br>* Relaxation treatment in technique of Jacobson<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression - Patient Health Questionnaire-9 | 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. | Measurement of PHQ-Data 3 months after inclusion of participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - European Quality 5 Dimensions on 3 Levels | 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 | Measurement of QoL 3 months after inclusion of participant | 
| Anxiety - Generalized Anxiety Disorder | 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. | Measurement of Generalized Anxiety 3 months after inclusion of participant | 
| Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q) | 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. | Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance, Mindfulness, Commitment, Group-Psychotherapy