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Completed

NCT Number: NCT01483339

Metacognitive Therapy for Patients With 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 Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy

Marburg, Hesse, 35037, Germany

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

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; YBOCS) from Pretest to Posttest to Follow-up

    Time frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

Secondary outcomes

  1. Change in Symptom Severity (Padua Inventory; PI) from Pretest to two in-between timepoints to Posttest to Follow-up

    Time frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  2. Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up

    Time frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

    Metacognitions (MCQ), Thought Fusion Inventory (TFI), Thought Action Fusion Scale (TAF-scale), Beliefs About Rituals Inventory (BARI), Stop Signals Questionnaire (SSQ), Detached Mindfulness Questionnaire (DMQ)

  3. Change in Obsessive Beliefs (Obsessive-Beliefs Questionnaire, OBQ) from Pretest to two in-between timepoints to Posttest to Follow-up

    Time frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  4. Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT) from Pretest to two in-between timepoints to Posttest to Follow-up

    Time frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  5. Change in Depression (Beck Depression Inventory, BDI) from Pretest to Posttest to Follow-up

    Time frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  6. Change in Anxiety (Beck Anxiety Inventory, BAI) from Pretest to Posttest to Follow-up

    Time frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  7. Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up

    Time frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

    Self rating and clinician rating of Helping Alliance Questionaire (HAQ) and Working Alliance Inventory (WAI)

  8. Change in Symptom Severity (Clinical Global Impressions; CGI) from Pretest to two in-between timepoints to Posttest to Follow-up

    Time frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)

  9. Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session

    Time frame: after the first treatment session (an expected average of 1 week after admission)

  10. Satisfaction with the treatment at Posttest

    Time frame: immediately after completion of therapy (an expected average of 3 months after admission)

  11. Change in Symptom Severity (Obsessive-Compulsive Disorder Scale; OCD-S) measured before every treatment session

    Time frame: from the first treatment session (an expected average of 1 week after admission) to the last treatment session (an expected average of 3 months after admission) on a weekly basis

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Psychotherapie-Ambulanz Marburg e.V.

Registry information

Official study title

Metacognitive Therapy Versus Exposition With Response Prevention for Patients With Obsessive-Compulsive Disorder

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2011
Registry last updated
Oct 6, 2017

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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