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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.8 years study duration

Study Start

First participant enrolled

November 1, 2011

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed

15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed

Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

5.7 years

First QC Date

November 16, 2011

Last Update Submit

October 5, 2017

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

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 Outcomes (11)

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
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)
+6 more secondary outcomes

Study Arms (2)