Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder

Metacognitive Therapy Versus Exposition With Response Prevention for Patients 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: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Metacognitive Therapy; Behavioral: Exposure and Response Prevention

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35037
      • Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metacognitive Therapy	Behavioral: Metacognitive Therapy; Metacognitive Therapy for OCD according to Wells (1997)
Experimental: Exposure and Response Prevention	Behavioral: Exposure and Response Prevention; Exposure and Response Prevention for OCD according to Kozak & Foa (1997)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Collaborators: Psychotherapie-Ambulanz Marburg e.V.
• Investigators: Principal Investigator: Cornelia Exner, Prof. Dr., University of Leipzig; Study Director: Winfried Rief, Prof. Dr., Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: MCT_OCD_2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No