Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483339
• Other study ID #: MCT_OCD_2011
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: October 5, 2017
• Start date: November 2011
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Metacognitive Therapy
Metacognitive Therapy for OCD according to Wells (1997)
• Exposure and Response Prevention
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)

Locations

Country	Name	City	State
Germany	Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy	Marburg	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Psychotherapie-Ambulanz Marburg e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session		after the first treatment session (an expected average of 1 week after admission)
Secondary	Satisfaction with the treatment at Posttest		immediately after completion of therapy (an expected average of 3 months after admission)
Secondary	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

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