Metacognitive Therapy for Obsessive-Compulsive Disorder

NCT02867449 | Completed

• 1 other identifier: MCT_OCD
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Obsessive-Compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (1)

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

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

  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)

Secondary Outcomes (14)

• 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 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)

Study Arms (2)

Metacognitive Therapy

EXPERIMENTAL

Metacognitive Therapy for OCD according to Wells (1997)

Behavioral: Metacognitive Therapy

Exposure and Response Prevention

EXPERIMENTAL

Exposure and Response Prevention for OCD according to Kozak \& Foa (1997)

Behavioral: Exposure and Response Prevention

Interventions

Metacognitive Therapy BEHAVIORAL

Metacognitive Therapy for OCD according to Wells (1997)

Metacognitive Therapy

Exposure and Response Prevention BEHAVIORAL

Exposure and Response Prevention for OCD according to Kozak \& Foa (1997)

Exposure and Response Prevention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leipzig: lead
• Philipps University Marburg: collaborator
• German Research Foundation: collaborator

Study Sites (2)

Leipzig University

Leipzig, Germany

Location

Philipps University Marburg

Marburg, Germany

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Cornelia Exner, Prof. Dr.

  Leipzig University

  PRINCIPAL INVESTIGATOR

• Julia A. Glombiewski, Dr.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

• Alexandra Kleiman, Dr.

  Leipzig University

  STUDY DIRECTOR

• Anke Haberkamp, Dr.

  Philipps University Marburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Cornelia Exner

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: August 16, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

DE (2)