Treatment of Depression With Mindfulness, Acceptance and Commitment

NCT ID: NCT03692130

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2022-03-31

Brief Summary

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

Detailed Description

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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...).

Conditions

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Psychotherapy Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group with new treatment, one group with known and defined treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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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".

Group Type ACTIVE_COMPARATOR

Mindfulness, Acceptance and Commitment-Therapy

Intervention Type BEHAVIORAL

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.

Known Treatment

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

Group Type SHAM_COMPARATOR

Jacobson

Intervention Type BEHAVIORAL

Relaxation treatment in technique of Jacobson

Interventions

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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.

Intervention Type BEHAVIORAL

Jacobson

Relaxation treatment in technique of Jacobson

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Depressive Disorder

Exclusion Criteria

* Somatic disorder
* psychotic disorder
* personality disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

Neuropsychiatrischen Zentrums Hamburg-Altona

OTHER

Sponsor Role lead

Responsible Party

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Peter Tonn

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Tonn, MD

Role: PRINCIPAL_INVESTIGATOR

Managing Director

Locations

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Neuropsychiatric Center of Hamburg

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SCHULZE02

Identifier Type: -

Identifier Source: org_study_id

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