Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metacognitive Therapy for Obsessive-Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02867449
Recruitment Status : Unknown
Verified June 2018 by Cornelia Exner, University of Leipzig.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE June 30, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date June 26, 2018
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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 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 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 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 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 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 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 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 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 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) ]
  • 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
  • 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 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 satisfaction with the treatment [ Time Frame: immediately after completion of therapy (after an expected avarage of 12 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metacognitive Therapy for Obsessive-Compulsive Disorder
Official Title  ICMJE A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder (OCD)
Intervention  ICMJE
  • Behavioral: Metacognitive Therapy
    Metacognitive Therapy for OCD according to Wells (1997)
  • Behavioral: Exposure and Response Prevention
    Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
Study Arms  ICMJE
  • Experimental: Metacognitive Therapy
    Metacognitive Therapy for OCD according to Wells (1997)
    Intervention: Behavioral: Metacognitive Therapy
  • Experimental: Exposure and Response Prevention
    Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
    Intervention: Behavioral: Exposure and Response Prevention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867449
Other Study ID Numbers  ICMJE MCT_OCD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cornelia Exner, University of Leipzig
Study Sponsor  ICMJE University of Leipzig
Collaborators  ICMJE
  • Philipps University Marburg Medical Center
  • German Research Foundation
Investigators  ICMJE
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
PRS Account University of Leipzig
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP