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Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT01483339
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Psychotherapie-Ambulanz Marburg e.V.
Information provided by (Responsible Party):
Julia Anna Glombiewski, Philipps University Marburg Medical Center

Tracking Information
First Submitted Date  ICMJE November 16, 2011
First Posted Date  ICMJE December 1, 2011
Last Update Posted Date October 6, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; YBOCS) from Pretest to Posttest to Follow-up [ Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
  • Change in Symptom Severity (Padua Inventory; PI) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
  • Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
    Metacognitions (MCQ), Thought Fusion Inventory (TFI), Thought Action Fusion Scale (TAF-scale), Beliefs About Rituals Inventory (BARI), Stop Signals Questionnaire (SSQ), Detached Mindfulness Questionnaire (DMQ)
  • Change in Obsessive Beliefs (Obsessive-Beliefs Questionnaire, OBQ) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
  • Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
  • Change in Depression (Beck Depression Inventory, BDI) from Pretest to Posttest to Follow-up [ Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
  • Change in Anxiety (Beck Anxiety Inventory, BAI) from Pretest to Posttest to Follow-up [ Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
  • Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
    Self rating and clinician rating of Helping Alliance Questionaire (HAQ) and Working Alliance Inventory (WAI)
  • Change in Symptom Severity (Clinical Global Impressions; CGI) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ]
  • Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session [ Time Frame: after the first treatment session (an expected average of 1 week after admission) ]
  • Satisfaction with the treatment at Posttest [ Time Frame: immediately after completion of therapy (an expected average of 3 months after admission) ]
  • Change in Symptom Severity (Obsessive-Compulsive Disorder Scale; OCD-S) measured before every treatment session [ Time Frame: from the first treatment session (an expected average of 1 week after admission) to the last treatment session (an expected average of 3 months after admission) on a weekly basis ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder
Official Title  ICMJE Metacognitive Therapy Versus Exposition With Response Prevention for Patients 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
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
    Intervention: Behavioral: Metacognitive Therapy
  • Experimental: Exposure and Response Prevention
    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 Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2017)
37
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2011)
40
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date July 2017   (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

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 NCT01483339
Other Study ID Numbers  ICMJE MCT_OCD_2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julia Anna Glombiewski, Philipps University Marburg Medical Center
Study Sponsor  ICMJE Philipps University Marburg Medical Center
Collaborators  ICMJE Psychotherapie-Ambulanz Marburg e.V.
Investigators  ICMJE
Principal Investigator: Cornelia Exner, Prof. Dr. University of Leipzig
Study Director: Winfried Rief, Prof. Dr. Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
PRS Account Philipps University Marburg Medical Center
Verification Date October 2017

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