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Metacognitive Therapy for Obsessive-Compulsive Disorder

Not Applicable
Completed
Conditions
Obsessive-Compulsive Disorder (OCD)
Registration Number
NCT02867449
Lead Sponsor
University of Leipzig
Brief Summary

Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder. However, the majority of treated patients remain symptomatic. The metacognitive therapy by Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this study is to investigate this approach with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.

Detailed Description

The purpose of this study is to investigate metacognitive therapy by Wells (1997) with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
74
Inclusion Criteria
  • Primary diagnosis: obsessive-compulsive disorder
  • German-speaking
  • Agreeing to participate, verified by completion of informed consent
  • Stable medication (at least 4 weeks)
Exclusion Criteria
  • Current or past diagnosis of substance dependence, psychosis, neurological conditions
  • Mental retardation

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)

Secondary Outcome Measures
NameTimeMethod
Change in Depression (Beck Depression Inventory, BDI-II)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Depression (Beck Depression Inventory, BDI-II)

Change in Symptom Severity (Clinical Global Impressions; CGI)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Symptom Severity (Clinical Global Impressions; CGI)

Difference in efficiency (length of treatment)immediately after completion of therapy (after an expected avarage of 12 weeks)

documentation of number of sessions

Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)after completion of 6 therapeutic sessions (after an expected avarage of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected avarage of 12 weeks), at follow-up (6 months after end of treatment)

Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)

Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)

Difference in satisfaction with the treatmentimmediately after completion of therapy (after an expected avarage of 12 weeks)

Difference in satisfaction with the treatment

Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)

Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)

Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)

Change in Anxiety (Beck Anxiety Inventory, BAI)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Anxiety (Beck Anxiety Inventory, BAI)

Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)

Difference in medical costs (based on the length of treatment)immediately after completion of therapy (after an expected avarage of 12 weeks)

Difference in medical costs (based on the length of treatment)

Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)

Change in Symptom Severity (Padua Inventory; PI)at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Symptom Severity (Padua Inventory; PI)

Trial Locations

Locations (2)

Leipzig University

🇩🇪

Leipzig, Germany

Philipps University Marburg

🇩🇪

Marburg, Germany

Leipzig University
🇩🇪Leipzig, Germany
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