Mindfulness-based Cognitive Therapy for Chronic Depression

Phase 2

Completed

• Conditions: Chronic Major Depression
• Interventions: Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy; Behavioral: Mindfulness-based Cognitive Therapy; Biological: Standard psychiatric care

• Registration Number: NCT01065311
• Lead Sponsor: Johannes Michalak

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Study Start: 2010-10
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBASP	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 by an instructor in eight weekly 2.5 hr group sessions.
CBASP	Standard psychiatric care	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.
Treatment-as-usual	Standard psychiatric 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
Mindfulness-based Cognitive Therapy	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.
Mindfulness-based Cognitive Therapy	Standard psychiatric care	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression	Change from Baseline in HAM-D at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory II	Change from Baseline in BDI-II at 6 months
Social Adaption Self-evaluation Scale	Change from Baseline in SASS at 6 months
Short Form (36) Health Survey	Change from Baseline in SF-36 at 6 months
Global Assessment of Functioning Scale	Change from Baseline in GAF at 6 months
Response Styles Questionnaire	Change from Baseline in RSQ at 6 months

Trial Locations

Locations (1)

University of Hildesheim; 🇩🇪 Hildesheim, Germany