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Clinical Trials/NCT03692130
NCT03692130
Unknown
Not Applicable

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

Neuropsychiatrischen Zentrums Hamburg-Altona1 site in 1 country120 target enrollmentMarch 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychotherapy
Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Enrollment
120
Locations
1
Primary Endpoint
Depression - Patient Health Questionnaire-9
Last Updated
4 years ago

Overview

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...).

Registry
clinicaltrials.gov
Start Date
March 18, 2019
End Date
March 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Responsible Party
Principal Investigator
Principal Investigator

Peter Tonn

Director

Neuropsychiatrischen Zentrums Hamburg-Altona

Eligibility Criteria

Inclusion Criteria

  • Depressive Disorder

Exclusion Criteria

  • Somatic disorder
  • psychotic disorder
  • personality disorder

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Quality of Life - European Quality 5 Dimensions on 3 Levels(Measurement of QoL 3 months after inclusion of participant)
  • Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)(Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant)
  • Anxiety - Generalized Anxiety Disorder(Measurement of Generalized Anxiety 3 months after inclusion of participant)

Study Sites (1)

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