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Completed

NCT Number: NCT02867449

Metacognitive Therapy for Obsessive-Compulsive Disorder

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.

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Key information

Conditions

Obsessive-Compulsive Disorder (OCD) Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leipzig University, Leipzig, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metacognitive Therapy

Behavioral

Metacognitive Therapy for OCD according to Wells (1997)

Exposure and Response Prevention

Behavioral

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

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. 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)

    Change in Symptom Severity (Padua Inventory; PI)

  2. 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)

    Change in general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)

  3. 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)

    Change in Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)

  4. 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)

    Change in Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)

  5. 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)

    Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT)

  6. 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)

    Change in Depression (Beck Depression Inventory, BDI-II)

  7. 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)

    Change in Anxiety (Beck Anxiety Inventory, BAI)

  8. 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)

    Change in Symptom Severity (Clinical Global Impressions; CGI)

  9. 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)

    Change in psychosocial functioning (Global Assessment of Functioning Scale, GAF)

  10. 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)

    Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)

  11. Difference in efficiency (length of treatment)

    Time frame: immediately after completion of therapy (after an expected avarage of 12 weeks)

    documentation of number of sessions

  12. Difference in medical costs (based on the length of treatment)

    Time frame: immediately after completion of therapy (after an expected avarage of 12 weeks)

    Difference in medical costs (based on the length of treatment)

  13. 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)

    Difference in negative effects of psychotherapy (Inventory for the Assessment of Negative Effects of Psychotherapy, INEP)

  14. Difference in satisfaction with the treatment

    Time frame: immediately after completion of therapy (after an expected avarage of 12 weeks)

    Difference in satisfaction with the treatment

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • German Research Foundation
  • Philipps University Marburg

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2016
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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