Metacognitive Therapy for Patients With 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.

Official Title
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Metacognitive Therapy Versus Exposition With Response Prevention for Patients With Obsessive-Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

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 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive Therapy<br> | Behavioral: Metacognitive Therapy<br>* Metacognitive Therapy for OCD according to Wells (1997)<br>|
| Experimental: Exposure and Response Prevention<br> | 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; YBOCS) from Pretest to Posttest to Follow-up |  | from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symptom Severity (Padua Inventory; PI) from Pretest to two in-between timepoints to Posttest to Follow-up |  | from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up | Metacognitions (MCQ), Thought Fusion Inventory (TFI), Thought Action Fusion Scale (TAF-scale), Beliefs About Rituals Inventory (BARI), Stop Signals Questionnaire (SSQ), Detached Mindfulness Questionnaire (DMQ) | from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Change in Obsessive Beliefs (Obsessive-Beliefs Questionnaire, OBQ) from Pretest to two in-between timepoints to Posttest to Follow-up |  | from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT) from Pretest to two in-between timepoints to Posttest to Follow-up |  | from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Change in Depression (Beck Depression Inventory, BDI) from Pretest to Posttest to Follow-up |  | from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Change in Anxiety (Beck Anxiety Inventory, BAI) from Pretest to Posttest to Follow-up |  | from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up | Self rating and clinician rating of Helping Alliance Questionaire (HAQ) and Working Alliance Inventory (WAI) | from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Change in Symptom Severity (Clinical Global Impressions; CGI) from Pretest to two in-between timepoints to Posttest to Follow-up |  | from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) | 
| Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session |  | after the first treatment session (an expected average of 1 week after admission) | 
| Satisfaction with the treatment at Posttest |  | immediately after completion of therapy (an expected average of 3 months after admission) | 
| Change in Symptom Severity (Obsessive-Compulsive Disorder Scale; OCD-S) measured before every treatment session |  | from the first treatment session (an expected average of 1 week after admission) to the last treatment session (an expected average of 3 months after admission) on a weekly basis |