Treatment of Depression With Mindfulness, Acceptance and Commitment

Depression Clinical Trial

— MAC_Depr  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03692130
• Other study ID #: SCHULZE02
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: March 2022

Study information

• Verified date: August 2021
• Source: Neuropsychiatrischen Zentrums Hamburg-Altona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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...).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Depressive Disorder

Exclusion Criteria:

• Somatic disorder
• psychotic disorder
• personality disorder

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Psychotherapy

Intervention

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.
• Jacobson
Relaxation treatment in technique of Jacobson

Locations

Country	Name	City	State
Germany	Neuropsychiatric Center of Hamburg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Neuropsychiatrischen Zentrums Hamburg-Altona	Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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