Treatment of Depression With Mindfulness, Acceptance and Commitment

Not Applicable

• Conditions: Depression; Psychotherapy

• Registration Number: NCT03692130
• Lead Sponsor: Neuropsychiatrischen Zentrums Hamburg-Altona

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Study Start: 2019-03-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-20
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Depressive Disorder

Exclusion Criteria

• Somatic disorder
• psychotic disorder
• personality disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression - Patient Health Questionnaire-9	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life - European Quality 5 Dimensions on 3 Levels	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
Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)	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.
Anxiety - Generalized Anxiety Disorder	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.

Trial Locations

Locations (1)

Neuropsychiatric Center of Hamburg; 🇩🇪 Hamburg, Germany