A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder

University of Leipzig2 sites in 1 country74 target enrollmentJune 2016

ConditionsObsessive-Compulsive Disorder (OCD)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obsessive-Compulsive Disorder (OCD)
Sponsor: University of Leipzig
Enrollment: 74
Locations: 2
Primary Endpoint: Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

The purpose of this study is to investigate metacognitive therapy by Wells (1997) with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

January 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Leipzig

Responsible Party

Principal Investigator

Cornelia Exner

Prof. Dr. Cornelia Exner

University of Leipzig

Eligibility Criteria

Inclusion Criteria

•Primary diagnosis: obsessive-compulsive disorder
•German-speaking
•Agreeing to participate, verified by completion of informed consent
•Stable medication (at least 4 weeks)

Exclusion Criteria

•Current or past diagnosis of substance dependence, psychosis, neurological conditions
•Mental retardation

Outcomes

Primary Outcomes

Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)

Time Frame: at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment)

Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)

Secondary Outcomes

Change in Symptom Severity (Padua Inventory; PI)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Change in Depression (Beck Depression Inventory, BDI-II)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Change in Symptom Severity (Clinical Global Impressions; CGI)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Difference in efficiency (length of treatment)(immediately after completion of therapy (after an expected avarage of 12 weeks))
Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)(after completion of 6 therapeutic sessions (after an expected avarage of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected avarage of 12 weeks), at follow-up (6 months after end of treatment))
Difference in satisfaction with the treatment(immediately after completion of therapy (after an expected avarage of 12 weeks))
Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Change in Anxiety (Beck Anxiety Inventory, BAI)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))
Difference in medical costs (based on the length of treatment)(immediately after completion of therapy (after an expected avarage of 12 weeks))
Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)(at pretest (admission), after completion of 6 therapeutic sessions (after an expected average of 6 weeks), at posttest after completion of 12 therapeutic sessions (after an expected average of 12 weeks), at follow-up (6 months after end of treatment))