Obsessive-Compulsive Disorder (OCD)
Conditions
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.
Interventions
BEHAVIORALMetacognitive Therapy
Metacognitive Therapy for OCD according to Wells (1997)
BEHAVIORALExposure and Response Prevention
Exposure and Response Prevention for OCD according to Kozak \& Foa (1997)
Sponsors
German Research Foundation
University of Leipzig
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Severity (Padua Inventory; PI) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | immediately after completion of therapy (after an expected avarage of 12 weeks) | Difference in satisfaction with the treatment |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORCornelia Exner, Prof. Dr.
Leipzig University
PRINCIPAL_INVESTIGATORJulia A. Glombiewski, Dr.
Philipps University Marburg
STUDY_DIRECTORAlexandra Kleiman, Dr.
Leipzig University
STUDY_DIRECTORAnke Haberkamp, Dr.
Philipps University Marburg
Outcome results
None listed