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Completed

NCT Number: NCT01065311

Mindfulness-based Cognitive Therapy for Chronic Depression

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).

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Key information

Conditions

Chronic Major Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Hildesheim

Hildesheim, 31141, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy

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

The Cognitive Behavioral Analysis System of Psychotherapy

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

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

Other names: Psychiatric care, neurologic care, ambulant setting

Primary outcomes

  1. Hamilton Rating Scale for Depression

    Time frame: Change from Baseline in HAM-D at 8 weeks

Secondary outcomes

  1. Beck Depression Inventory II

    Time frame: Change from Baseline in BDI-II at 8 weeks

  2. Social Adaption Self-evaluation Scale

    Time frame: Change from Baseline in SASS at 8 weeks

  3. Short Form (36) Health Survey

    Time frame: Change from Baseline in SF-36 at 8 weeks

  4. Global Assessment of Functioning Scale

    Time frame: Change from Baseline in HAM-D at 8 weeks

  5. Response Styles Questionnaire

    Time frame: Change from Baseline in RSQ at 8 weeks

  6. Beck Depression Inventory II

    Time frame: Change from Baseline in BDI-II at 6 months

  7. Social Adaption Self-evaluation Scale

    Time frame: Change from Baseline in SASS at 6 months

  8. Short Form (36) Health Survey

    Time frame: Change from Baseline in SF-36 at 6 months

  9. Global Assessment of Functioning Scale

    Time frame: Change from Baseline in GAF at 6 months

  10. Response Styles Questionnaire

    Time frame: Change from Baseline in RSQ at 6 months

Sponsors and collaborators

Lead sponsor

Johannes Michalak

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2010
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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