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Metacognitive Therapy for Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder (OCD)

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

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder (OCD)

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
  • Stable medication (at least 4 weeks)

Exclusion Criteria:

  • Current or past diagnosis of substance dependence, psychosis, neurological conditions
  • Mental retardation

Sites / Locations

  • Leipzig University
  • Philipps University Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Metacognitive Therapy

Exposure and Response Prevention

Arm Description

Metacognitive Therapy for OCD according to Wells (1997)

Exposure and Response Prevention for OCD according to Kozak & Foa (1997)

Outcomes

Primary Outcome Measures

Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)

Secondary Outcome Measures

Change in Symptom Severity (Padua Inventory; PI)
Change in Symptom Severity (Padua Inventory; PI)
Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)
Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)
Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)
Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)
Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)
Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)
Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)
Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)
Change in Depression (Beck Depression Inventory, BDI-II)
Change in Depression (Beck Depression Inventory, BDI-II)
Change in Anxiety (Beck Anxiety Inventory, BAI)
Change in Anxiety (Beck Anxiety Inventory, BAI)
Change in Symptom Severity (Clinical Global Impressions; CGI)
Change in Symptom Severity (Clinical Global Impressions; CGI)
Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)
Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)
Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)
Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)
Difference in efficiency (length of treatment)
documentation of number of sessions
Difference in medical costs (based on the length of treatment)
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)
Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)
Difference in satisfaction with the treatment
Difference in satisfaction with the treatment

Full Information

First Posted
June 30, 2016
Last Updated
September 24, 2021
Sponsor
University of Leipzig
Collaborators
Philipps University Marburg Medical Center, German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02867449
Brief Title
Metacognitive Therapy for Obsessive-Compulsive Disorder
Official Title
A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
Philipps University Marburg Medical Center, German Research Foundation

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive Therapy
Arm Type
Experimental
Arm Description
Metacognitive Therapy for OCD according to Wells (1997)
Arm Title
Exposure and Response Prevention
Arm Type
Experimental
Arm Description
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
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; Y-BOCS)
Description
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)
Secondary Outcome Measure Information:
Title
Change in Symptom Severity (Padua Inventory; PI)
Description
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)
Title
Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)
Description
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)
Title
Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)
Description
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)
Title
Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)
Description
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)
Title
Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)
Description
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)
Title
Change in Depression (Beck Depression Inventory, BDI-II)
Description
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)
Title
Change in Anxiety (Beck Anxiety Inventory, BAI)
Description
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)
Title
Change in Symptom Severity (Clinical Global Impressions; CGI)
Description
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)
Title
Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)
Description
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)
Title
Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)
Description
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)
Title
Difference in efficiency (length of treatment)
Description
documentation of number of sessions
Time Frame
immediately after completion of therapy (after an expected avarage of 12 weeks)
Title
Difference in medical costs (based on the length of treatment)
Description
Difference in medical costs (based on the length of treatment)
Time Frame
immediately after completion of therapy (after an expected avarage of 12 weeks)
Title
Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)
Description
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)
Title
Difference in satisfaction with the treatment
Description
Difference in satisfaction with the treatment
Time Frame
immediately after completion of therapy (after an expected avarage of 12 weeks)

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 Stable medication (at least 4 weeks) 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
Leipzig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia A. Glombiewski, Dr.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandra Kleiman, Dr.
Organizational Affiliation
Leipzig University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anke Haberkamp, Dr.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Leipzig University
City
Leipzig
Country
Germany
Facility Name
Philipps University Marburg
City
Marburg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Metacognitive Therapy for Obsessive-Compulsive Disorder

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