- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02867449
Metacognitive Therapy for Obsessive-Compulsive Disorder
August 5, 2026 updated by: Cornelia Exner, University of Leipzig
A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leipzig, Germany
- Leipzig University
-
Marburg, Germany
- Philipps University Marburg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metacognitive Therapy
Metacognitive Therapy for OCD according to Wells (1997)
|
Metacognitive Therapy for OCD according to Wells (1997)
|
|
Experimental: Exposure and Response Prevention
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
|
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
Time Frame: 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)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Symptom Severity (Padua Inventory; PI)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
|
|
Difference in efficiency (length of treatment)
Time Frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
|
documentation of number of sessions
|
immediately after completion of therapy (after an expected avarage of 12 weeks)
|
|
Difference in medical costs (based on the length of treatment)
Time Frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
|
Difference in medical costs (based on the length of treatment)
|
immediately after completion of therapy (after an expected avarage of 12 weeks)
|
|
Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)
Time Frame: 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)
|
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 satisfaction with the treatment
Time Frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
|
Difference in satisfaction with the treatment
|
immediately after completion of therapy (after an expected avarage of 12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cornelia Exner, Prof. Dr., Leipzig University
- Study Director: Alexandra Kleiman, Dr., Leipzig University
- Principal Investigator: Julia A. Glombiewski, Dr., Philipps University Marburg
- Study Director: Anke Haberkamp, Dr., Philipps University Marburg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
June 30, 2016
First Submitted That Met QC Criteria
August 10, 2016
First Posted (Estimated)
August 16, 2016
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 5, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCT_OCD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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