Mindfulness-based Cognitive Therapy for Chronic Depression

Chronic Major Depression Clinical Trial

Official title:

Mindfulness-based Cognitive Therapy for Chronic Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065311
• Other study ID #: DFG Mi 700/4
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2010
• Last updated: May 14, 2014
• Start date: October 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Major Depression
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• 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
• 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.

Biological:
• 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

Locations

Country	Name	City	State
Germany	University of Hildesheim	Hildesheim

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Michalak

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression		Change from Baseline in HAM-D at 8 weeks	No
Secondary	Beck Depression Inventory II		Change from Baseline in BDI-II at 8 weeks	No
Secondary	Social Adaption Self-evaluation Scale		Change from Baseline in SASS at 8 weeks	No
Secondary	Short Form (36) Health Survey		Change from Baseline in SF-36 at 8 weeks	No
Secondary	Global Assessment of Functioning Scale		Change from Baseline in HAM-D at 8 weeks	No
Secondary	Response Styles Questionnaire		Change from Baseline in RSQ at 8 weeks	No
Secondary	Beck Depression Inventory II		Change from Baseline in BDI-II at 6 months	No
Secondary	Social Adaption Self-evaluation Scale		Change from Baseline in SASS at 6 months	No
Secondary	Short Form (36) Health Survey		Change from Baseline in SF-36 at 6 months	No
Secondary	Global Assessment of Functioning Scale		Change from Baseline in GAF at 6 months	No
Secondary	Response Styles Questionnaire		Change from Baseline in RSQ at 6 months	No