Metacognitive Therapy for Obsessive-Compulsive Disorder

September 24, 2021 updated by: Cornelia Exner, University of Leipzig

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany
        • Leipzig University
      • Marburg, Germany
        • Philipps University Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metacognitive Therapy
Metacognitive Therapy for OCD according to Wells (1997)
Behavioral: Metacognitive Therapy
Metacognitive Therapy for OCD according to Wells (1997)
Experimental: Exposure and Response Prevention
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
Behavioral: Exposure and Response Prevention
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Symptom Severity (Padua Inventory; PI)
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 (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)
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 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)
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 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)
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 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)
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 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 Depression (Beck Depression Inventory, BDI-II)
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 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 Anxiety (Beck Anxiety Inventory, BAI)
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 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 Symptom Severity (Clinical Global Impressions; CGI)
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 (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)
Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)
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 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)
Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)
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 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 efficiency (length of treatment)
Time Frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
documentation of number of sessions
immediately after completion of therapy (after an expected avarage of 12 weeks)
Difference in medical costs (based on the length of treatment)
Time Frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
Difference in medical costs (based on the 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)
Time Frame: 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 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
Time Frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
Difference in satisfaction with the treatment
immediately after completion of therapy (after an expected avarage of 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

German Research Foundation
Philipps University Marburg Medical Center

Investigators

  • Principal Investigator: Cornelia Exner, Prof. Dr., Leipzig University
  • Principal Investigator: Julia A. Glombiewski, Dr., Philipps University Marburg Medical Center
  • Study Director: Alexandra Kleiman, Dr., Leipzig University
  • Study Director: Anke Haberkamp, Dr., Philipps University Marburg Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT_OCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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