Clinical trial NCT01065311: Mindfulness-based Cognitive Therapy for Chronic Depression
Official title: Mindfulness-based Cognitive Therapy for Chronic Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Major Depression
Keywords: Depressive Disorder
Psychotherapy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: Change from Baseline in HAM-D at 8 weeks
Secondary outcomes:
measure: Beck Depression Inventory II
timeFrame: Change from Baseline in BDI-II at 8 weeks
measure: Social Adaption Self-evaluation Scale
timeFrame: Change from Baseline in SASS at 8 weeks
measure: Short Form (36) Health Survey
timeFrame: Change from Baseline in SF-36 at 8 weeks
measure: Global Assessment of Functioning Scale
timeFrame: Change from Baseline in HAM-D at 8 weeks
measure: Response Styles Questionnaire
timeFrame: Change from Baseline in RSQ at 8 weeks
measure: Beck Depression Inventory II
timeFrame: Change from Baseline in BDI-II at 6 months
measure: Social Adaption Self-evaluation Scale
timeFrame: Change from Baseline in SASS at 6 months
measure: Short Form (36) Health Survey
timeFrame: Change from Baseline in SF-36 at 6 months
measure: Global Assessment of Functioning Scale
timeFrame: Change from Baseline in GAF at 6 months
measure: Response Styles Questionnaire
timeFrame: Change from Baseline in RSQ at 6 months
Other outcomes:
Locations:
city: Hildesheim
country: Germany
facility: University of Hildesheim
Study officials:
affiliation: University of Hildesheim
name: Johannes Michalak, PD Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.