Metacognitive Therapy for Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder (OCD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867449
• Other study ID #: MCT_OCD
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2020

Study information

• Verified date: September 2021
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder (OCD)

Intervention

Behavioral:
• Metacognitive Therapy
Metacognitive Therapy for OCD according to Wells (1997)
• Exposure and Response Prevention
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)

Locations

Country	Name	City	State
Germany	Leipzig University	Leipzig
Germany	Philipps University Marburg	Marburg

Sponsors (3)

Lead Sponsor	Collaborator
University of Leipzig	German Research Foundation, Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)	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)
Secondary	Change in Symptom Severity (Padua Inventory; PI)	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)
Secondary	Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)	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)
Secondary	Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)	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)
Secondary	Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)	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)
Secondary	Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)	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)
Secondary	Change in Depression (Beck Depression Inventory, BDI-II)	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)
Secondary	Change in Anxiety (Beck Anxiety Inventory, BAI)	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)
Secondary	Change in Symptom Severity (Clinical Global Impressions; CGI)	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)
Secondary	Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)	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)
Secondary	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)	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	Difference in efficiency (length of treatment)	documentation of number of sessions	immediately after completion of therapy (after an expected avarage of 12 weeks)
Secondary	Difference in medical costs (based on the length of treatment)	Difference in medical costs (based on the length of treatment)	immediately after completion of therapy (after an expected avarage of 12 weeks)
Secondary	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)	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)
Secondary	Difference in satisfaction with the treatment	Difference in satisfaction with the treatment	immediately after completion of therapy (after an expected avarage of 12 weeks)