Clinical trial NCT02867449: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder (OCD)
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Philipps University Marburg
name: German Research Foundation
First posted: 2016-08-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
timeFrame: 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 outcomes:
measure: Change in Symptom Severity (Padua Inventory; PI)
timeFrame: 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)
measure: Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)
timeFrame: 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)
measure: Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)
timeFrame: 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)
measure: Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)
timeFrame: 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)
measure: Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)
timeFrame: 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)
measure: Change in Depression (Beck Depression Inventory, BDI-II)
timeFrame: 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)
measure: Change in Anxiety (Beck Anxiety Inventory, BAI)
timeFrame: 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)
measure: Change in Symptom Severity (Clinical Global Impressions; CGI)
timeFrame: 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)
measure: Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)
timeFrame: 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)
measure: Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)
timeFrame: 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)
measure: Difference in efficiency (length of treatment)
timeFrame: immediately after completion of therapy (after an expected avarage of 12 weeks)
measure: Difference in medical costs (based on the length of treatment)
timeFrame: immediately after completion of therapy (after an expected avarage of 12 weeks)
measure: Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)
timeFrame: 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)
measure: Difference in satisfaction with the treatment
timeFrame: immediately after completion of therapy (after an expected avarage of 12 weeks)
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig University
city: Marburg
country: Germany
facility: Philipps University Marburg
Study officials:
affiliation: Leipzig University
name: Cornelia Exner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Julia A. Glombiewski, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Leipzig University
name: Alexandra Kleiman, Dr.
role: STUDY_DIRECTOR
affiliation: Philipps University Marburg
name: Anke Haberkamp, Dr.
role: STUDY_DIRECTOR
References: