Clinical trial NCT01483339: Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder
Official title: Metacognitive Therapy Versus Exposition With Response Prevention for Patients With Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Psychotherapie-Ambulanz Marburg e.V.
First posted: 2011-12-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; YBOCS) from Pretest to Posttest to Follow-up
timeFrame: 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 outcomes:
measure: Change in Symptom Severity (Padua Inventory; PI) from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in Obsessive Beliefs (Obsessive-Beliefs Questionnaire, OBQ) from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT) from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in Depression (Beck Depression Inventory, BDI) from Pretest to Posttest to Follow-up
timeFrame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
measure: Change in Anxiety (Beck Anxiety Inventory, BAI) from Pretest to Posttest to Follow-up
timeFrame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
measure: Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Change in Symptom Severity (Clinical Global Impressions; CGI) from Pretest to two in-between timepoints to Posttest to Follow-up
timeFrame: 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)
measure: Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session
timeFrame: after the first treatment session (an expected average of 1 week after admission)
measure: Satisfaction with the treatment at Posttest
timeFrame: immediately after completion of therapy (an expected average of 3 months after admission)
measure: Change in Symptom Severity (Obsessive-Compulsive Disorder Scale; OCD-S) measured before every treatment session
timeFrame: 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
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy
state: Hessen
Study officials:
affiliation: University of Leipzig
name: Cornelia Exner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
name: Winfried Rief, Prof. Dr.
role: STUDY_DIRECTOR
References: