Treatment of Depression With Mindfulness, Acceptance and Commitment

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Peter Tonn，Neuropsychiatrischen Zentrums Hamburg-Altona

Tracking Information

First Submitted Date ^ICMJE

August 23, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Quality of Life - European Quality 5 Dimensions on 3 Levels[ Time Frame: 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
Anxiety - Generalized Anxiety Disorder[ Time Frame: 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.
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 ]
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.

Descriptive Information

Brief Title ^ICMJE

Treatment of Depression With Mindfulness, Acceptance and Commitment

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group with new treatment, one group with known and defined treatment
Masking: Interventional
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
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.
Behavioral: Jacobson
Relaxation treatment in technique of Jacobson

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 2020

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Depressive Disorder Exclusion Criteria: - Somatic disorder - psychotic disorder - personality disorder

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Peter Tonn，Neuropsychiatrischen Zentrums Hamburg-Altona

Study Sponsor ^ICMJE

Neuropsychiatrischen Zentrums Hamburg-Altona

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Peter Tonn, MD Managing Director

PRS Account

Neuropsychiatrischen Zentrums Hamburg-Altona

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名