Treatment of Depression With Mindfulness, Acceptance and Commitment (MAC_Depr)
August 19, 2021 updated by: Peter Tonn, Neuropsychiatrischen Zentrums Hamburg-Altona
Mindfulness, Acceptance and Commitment Combined in Cognitive Behavioral Group Therapy (MAC-CBT®) for Patients With Depression
Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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...).
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany, 22769
- Neuropsychiatric Center of Hamburg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Depressive Disorder
Exclusion Criteria:
- Somatic disorder
- psychotic disorder
- personality disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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".
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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.
|
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Sham Comparator: Known Treatment
The participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique".
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Relaxation treatment in technique of Jacobson
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression - Patient Health Questionnaire-9
Time Frame: Measurement of PHQ-Data 3 months after inclusion of participant
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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.
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Measurement of PHQ-Data 3 months after inclusion of participant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life - European Quality 5 Dimensions on 3 Levels
Time Frame: Measurement of QoL 3 months after inclusion of participant
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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
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Measurement of QoL 3 months after inclusion of participant
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Anxiety - Generalized Anxiety Disorder
Time Frame: Measurement of Generalized Anxiety 3 months after inclusion of participant
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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.
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Measurement of Generalized Anxiety 3 months after inclusion of participant
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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
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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.
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Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter Tonn, MD, Managing Director
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2019
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
August 20, 2021
Last Update Submitted That Met QC Criteria
August 19, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCHULZE02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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