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Metacognitive Therapy for Obsessive-Compulsive Disorder

A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02867449
Enrollment
74
Registered
2016-08-16
Start date
2016-06-30
Completion date
2020-01-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder (OCD)

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

Metacognitive Therapy for OCD according to Wells (1997)

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

Sponsors

Philipps University Marburg
CollaboratorOTHER
German Research Foundation
CollaboratorOTHER
University of Leipzig
Lead SponsorOTHER

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

MeasureTime frameDescription
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

MeasureTime frameDescription
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 (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 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 treatmentimmediately after completion of therapy (after an expected avarage of 12 weeks)Difference in satisfaction with the treatment
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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026