Mindfulness-based Cognitive Therapy for Chronic Depression

NCT ID: NCT01065311

Last Updated: 2014-05-15

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-05-31

Brief Summary

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The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive Therapy (MBCT, Segal, Williams, \& Teasdale, 2002) for patients suffering from Chronic Major Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).

Detailed Description

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Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a treatment approach specifically developed for the treatment of chronic depression. CBASP aims to change dysfunctional interpersonal patterns. Mindfulness-based Cognitive Therapy (MBCT) has recently been proposed as a further treatment option for chronic depression. MBCT trains patients to step out of negative ruminative states of mind. There are no direct comparisons of the psychological treatment options for chronic depression.

Conditions

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Chronic Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness-based Cognitive Therapy

Mindfulness-based Cognitive Therapy is based on an integration of certain aspects of cognitive behavioral therapy for depression (Beck et al., 1979) and components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.

Group Type EXPERIMENTAL

Mindfulness-based Cognitive Therapy

Intervention Type BEHAVIORAL

Mindfulness-based Cognitive Therapy is based on an integration of aspects of cognitive behavioral therapy for depression (Beck et al., 1979) with components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions

Standard psychiatric care

Intervention Type BIOLOGICAL

Antidepressant medication and medical care.

Standard psychiatric outpatient care:

All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

CBASP

The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions.

Group Type ACTIVE_COMPARATOR

The Cognitive Behavioral Analysis System of Psychotherapy

Intervention Type BEHAVIORAL

The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.

Standard psychiatric care

Intervention Type BIOLOGICAL

Antidepressant medication and medical care.

Standard psychiatric outpatient care:

All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

Treatment-as-usual

Standard psychiatric outpatient care:

All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

Group Type ACTIVE_COMPARATOR

Standard psychiatric care

Intervention Type BIOLOGICAL

Antidepressant medication and medical care.

Standard psychiatric outpatient care:

All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

Interventions

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Mindfulness-based Cognitive Therapy

Mindfulness-based Cognitive Therapy is based on an integration of aspects of cognitive behavioral therapy for depression (Beck et al., 1979) with components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions

Intervention Type BEHAVIORAL

The Cognitive Behavioral Analysis System of Psychotherapy

The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.

Intervention Type BEHAVIORAL

Standard psychiatric care

Antidepressant medication and medical care.

Standard psychiatric outpatient care:

All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

Intervention Type BIOLOGICAL

Other Intervention Names

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Psychiatric care neurologic care ambulant setting

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnoses of Major Depression, single episode, chronic or
* Major Depression, recurrent, chronic
* Hamilton Rating Scale for Depression score \> 14
* Beck Depression Inventory II score \> 14

Exclusion Criteria

* History of Schizophrenia or Schizoaffective Disorder
* Current Substance Dependence or Eating Disorder
* Mental Disorder Due to General Medical Condition
* Borderline Personality Disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Michalak

OTHER

Sponsor Role lead

Responsible Party

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Johannes Michalak

Prof. Dr. phil.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Johannes Michalak, PD Dr. phil.

Role: PRINCIPAL_INVESTIGATOR

University of Hildesheim

Locations

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University of Hildesheim

Hildesheim, , Germany

Site Status

Countries

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Germany

References

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Forkmann T, Brakemeier EL, Teismann T, Schramm E, Michalak J. The Effects of Mindfulness-Based Cognitive Therapy and Cognitive Behavioral Analysis System of Psychotherapy added to Treatment as Usual on suicidal ideation in chronic depression: Results of a randomized-clinical trial. J Affect Disord. 2016 Aug;200:51-7. doi: 10.1016/j.jad.2016.01.047. Epub 2016 Apr 19.

Reference Type DERIVED
PMID: 27128357 (View on PubMed)

Michalak J, Schultze M, Heidenreich T, Schramm E. A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients. J Consult Clin Psychol. 2015 Oct;83(5):951-63. doi: 10.1037/ccp0000042. Epub 2015 Aug 10.

Reference Type DERIVED
PMID: 26371617 (View on PubMed)

Other Identifiers

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DFG Mi 700/4

Identifier Type: -

Identifier Source: org_study_id

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