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Treatment of Depression With Mindfulness, Acceptance and Commitment (MAC_Depr)

Primary Purpose

Psychotherapy, Depression

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness, Acceptance and Commitment-Therapy
Jacobson
Sponsored by
Neuropsychiatrischen Zentrums Hamburg-Altona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotherapy focused on measuring Acceptance, Mindfulness, Commitment, Group-Psychotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Depressive Disorder

Exclusion Criteria:

  • Somatic disorder
  • psychotic disorder
  • personality disorder

Sites / Locations

  • Neuropsychiatric Center of Hamburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

New Treatment

Known Treatment

Arm Description

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".

The participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique".

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
August 23, 2018
Last Updated
August 19, 2021
Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Collaborators
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT03692130
Brief Title
Treatment of Depression With Mindfulness, Acceptance and Commitment
Acronym
MAC_Depr
Official Title
Mindfulness, Acceptance and Commitment Combined in Cognitive Behavioral Group Therapy (MAC-CBT®) for Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuropsychiatrischen Zentrums Hamburg-Altona
Collaborators
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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...).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotherapy, Depression
Keywords
Acceptance, Mindfulness, Commitment, Group-Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group with new treatment, one group with known and defined treatment
Masking
ParticipantOutcomes Assessor
Masking Description
The participants don't know in which of the both arms they are, the outcome assessor don't know which participant of which study-arm he/she calculate
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New Treatment
Arm Type
Active Comparator
Arm Description
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".
Arm Title
Known Treatment
Arm Type
Sham Comparator
Arm Description
The participants will be treated with a relaxation-treatment, long time established as "jacobson muscle relaxing technique".
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness, Acceptance and Commitment-Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Jacobson
Intervention Description
Relaxation treatment in technique of Jacobson
Primary Outcome Measure Information:
Title
Depression - Patient Health Questionnaire-9
Description
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.
Time Frame
Measurement of PHQ-Data 3 months after inclusion of participant
Secondary Outcome Measure Information:
Title
Quality of Life - European Quality 5 Dimensions on 3 Levels
Description
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
Time Frame
Measurement of QoL 3 months after inclusion of participant
Title
Anxiety - Generalized Anxiety Disorder
Description
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.
Time Frame
Measurement of Generalized Anxiety 3 months after inclusion of participant
Title
Acceptance and Commitment - Questionnaire of Mindfulness, Acceptance and Commitment (MAC-Q)
Description
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.
Time Frame
Measurement of Mindfulness, Acceptance and Commitment 3 months after inclusion of participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Depressive Disorder Exclusion Criteria: Somatic disorder psychotic disorder personality disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Tonn, MD
Organizational Affiliation
Managing Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuropsychiatric Center of Hamburg
City
Hamburg
ZIP/Postal Code
22769
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Depression With Mindfulness, Acceptance and Commitment

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