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Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Metacognitive Therapy
Exposure and Response Prevention
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Metacognitive Therapy

Exposure and Response Prevention

Arm Description

Outcomes

Primary Outcome Measures

Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; YBOCS) from Pretest to Posttest to Follow-up

Secondary Outcome Measures

Change in Symptom Severity (Padua Inventory; PI) from Pretest to two in-between timepoints to Posttest to Follow-up
Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up
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
Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT) from Pretest to two in-between timepoints to Posttest to Follow-up
Change in Depression (Beck Depression Inventory, BDI) from Pretest to Posttest to Follow-up
Change in Anxiety (Beck Anxiety Inventory, BAI) from Pretest to Posttest to Follow-up
Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up
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
Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session
Satisfaction with the treatment at Posttest
Change in Symptom Severity (Obsessive-Compulsive Disorder Scale; OCD-S) measured before every treatment session

Full Information

First Posted
November 16, 2011
Last Updated
October 5, 2017
Sponsor
Philipps University Marburg Medical Center
Collaborators
Psychotherapie-Ambulanz Marburg e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01483339
Brief Title
Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder
Official Title
Metacognitive Therapy Versus Exposition With Response Prevention for Patients With Obsessive-Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Psychotherapie-Ambulanz Marburg e.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive Therapy
Arm Type
Experimental
Arm Title
Exposure and Response Prevention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive Therapy
Intervention Description
Metacognitive Therapy for OCD according to Wells (1997)
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention
Intervention Description
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up
Description
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)
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up
Description
Self rating and clinician rating of Helping Alliance Questionaire (HAQ) and Working Alliance Inventory (WAI)
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)
Title
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)
Title
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)
Title
Satisfaction with the treatment at Posttest
Time Frame
immediately after completion of therapy (an expected average of 3 months after admission)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Exner, Prof. Dr.
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Prof. Dr.
Organizational Affiliation
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Official's Role
Study Director
Facility Information:
Facility Name
Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.uni-marburg.de/fb04/ag-klin/pam
Description
Related Info

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Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder

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