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Metacognitive Therapy for Obsessive-Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT02867449
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Philipps University Marburg Medical Center
German Research Foundation
Information provided by (Responsible Party):
Cornelia Exner, University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder (OCD) Behavioral: Metacognitive Therapy Behavioral: Exposure and Response Prevention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder
Study Start Date : June 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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

  12. 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)

  13. 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)

  14. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867449


Contacts
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Contact: Cornelia Exner, Prof. Dr. exnerc@uni-leipzig.de

Locations
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Germany
Leipzig University Recruiting
Leipzig, Germany
Principal Investigator: Cornelia Exner, Prof. Dr.         
Philipps University Marburg Recruiting
Marburg, Germany
Principal Investigator: Julia A. Glombiewski, Dr.         
Sponsors and Collaborators
University of Leipzig
Philipps University Marburg Medical Center
German Research Foundation
Investigators
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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

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Responsible Party: Cornelia Exner, Prof. Dr. Cornelia Exner, University of Leipzig
ClinicalTrials.gov Identifier: NCT02867449     History of Changes
Other Study ID Numbers: MCT_OCD
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders