Mindfulness-based Cognitive Therapy for Chronic Depression

Study Overview
=================
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.

Official Title
-----------------
Mindfulness-based Cognitive Therapy for Chronic Depression

Conditions
-----------------
Chronic Major Depression

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based Cognitive Therapy
* Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy
* Biological: Standard psychiatric care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based Cognitive Therapy<br>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. | Behavioral: Mindfulness-based Cognitive Therapy<br>* 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<br>Biological: Standard psychiatric care<br>* 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<br>* Other names: ambulant setting;|
| Active Comparator: CBASP<br>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. | Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy<br>* 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.<br>Biological: Standard psychiatric care<br>* 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<br>* Other names: ambulant setting;|
| Active Comparator: Treatment-as-usual<br>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 | Biological: Standard psychiatric care<br>* 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<br>* Other names: ambulant setting;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression |  | Change from Baseline in HAM-D at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory II |  | Change from Baseline in BDI-II at 8 weeks | 
| Social Adaption Self-evaluation Scale |  | Change from Baseline in SASS at 8 weeks | 
| Short Form (36) Health Survey |  | Change from Baseline in SF-36 at 8 weeks | 
| Global Assessment of Functioning Scale |  | Change from Baseline in HAM-D at 8 weeks | 
| Response Styles Questionnaire |  | Change from Baseline in RSQ at 8 weeks | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depressive Disorder, Psychotherapy