Metacognitive Therapy for Obsessive-Compulsive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder (OCD)

Intervention / Treatment
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* Behavioral: Metacognitive Therapy
* Behavioral: Exposure and Response Prevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive Therapy<br>Metacognitive Therapy for OCD according to Wells (1997) | Behavioral: Metacognitive Therapy<br>* Metacognitive Therapy for OCD according to Wells (1997)<br>|
| Experimental: Exposure and Response Prevention<br>Exposure and Response Prevention for OCD according to Kozak & Foa (1997) | Behavioral: Exposure and Response Prevention<br>* Exposure and Response Prevention for OCD according to Kozak & Foa (1997)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | Difference in satisfaction with the treatment | immediately after completion of therapy (after an expected avarage of 12 weeks) |