Obsessive-Compulsive DisorderNCT01483339
Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder
A study testing Metacognitive Therapy and Exposure and Response Prevention in people with Obsessive-Compulsive Disorder, run by Philipps University Marburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Metacognitive Therapy and Exposure and Response Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis: obsessive-compulsive disorder
- German-speaking
- Agreeing to participate, verified by completion of informed consent
Who cannot join
- Current or past diagnosis of substance dependence, psychosis, neurological conditions
- Mental retardation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy
Marburg, Hesse, 35037
About this study
Official title: Metacognitive Therapy Versus Exposition With Response Prevention 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Metacognitive Therapy, Exposure and Response Prevention
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TherapyBehavioural
Metacognitive Therapy for OCD according to Wells (1997)
Exposure and Response PreventionBehavioural
Exposure and Response Prevention for OCD according to Kozak \& Foa (1997)
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Therapy | Experimental | Not described Receives: Behavioral: Metacognitive Therapy |
| Exposure and Response Prevention | Experimental | Not described Receives: Behavioral: Exposure and Response Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; YBOCS) from Pretest to Posttest to Follow-up
Measured: 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 (11)
Change in Symptom Severity (Padua Inventory; PI) from Pretest to two in-between timepoints to Posttest to Follow-up
Measured: 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)
Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up
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)
Measured: 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)
Change in Obsessive Beliefs (Obsessive-Beliefs Questionnaire, OBQ) from Pretest to two in-between timepoints to Posttest to Follow-up
Measured: 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)
Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT) from Pretest to two in-between timepoints to Posttest to Follow-up
Measured: 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)
Change in Depression (Beck Depression Inventory, BDI) from Pretest to Posttest to Follow-up
Measured: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Change in Anxiety (Beck Anxiety Inventory, BAI) from Pretest to Posttest to Follow-up
Measured: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up
Self rating and clinician rating of Helping Alliance Questionaire (HAQ) and Working Alliance Inventory (WAI)
Measured: 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)
Change in Symptom Severity (Clinical Global Impressions; CGI) from Pretest to two in-between timepoints to Posttest to Follow-up
Measured: 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)
Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session
Measured: after the first treatment session (an expected average of 1 week after admission)
Satisfaction with the treatment at Posttest
Measured: immediately after completion of therapy (an expected average of 3 months after admission)
Change in Symptom Severity (Obsessive-Compulsive Disorder Scale; OCD-S) measured before every treatment session
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Psychotherapie-Ambulanz Marburg e.V.
- Responsible party
- Principal investigator, Julia Anna Glombiewski, Philipps University Marburg
- Investigators
- Cornelia Exner, Prof. Dr., Principal investigator, University of LeipzigWinfried Rief, Prof. Dr., Study director, Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483339
- Sponsor's protocol ID
- MCT_OCD_2011
- Status last verified
- Oct 2017
- First submitted
- 16 Nov 2011
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Therapy Versus Exposition With Response Prevention for Patients With Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01483339
- Acronym / sponsor ID
- MCT_OCD_2011
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Psychotherapie-Ambulanz Marburg e.V.
- Study start
- Nov 2011
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy | Experimental | Behavioral: Metacognitive Therapy |
| Exposure and Response Prevention | Experimental | Behavioral: Exposure and Response Prevention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis: obsessive-compulsive disorder
- German-speaking
- Agreeing to participate, verified by completion of informed consent
Key exclusion criteria (2 listed)
- Current or past diagnosis of substance dependence, psychosis, neurological conditions
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive TherapyMetacognitive Therapy for OCD according to Wells (1997) | Behavioural | Metacognitive Therapy |
| Exposure and Response PreventionExposure and Response Prevention for OCD according to Kozak \& Foa (1997) | Behavioural | Exposure and Response Prevention |
Primary outcome
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)
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Satisfaction with the treatment at Posttest
Time frame: immediately after completion of therapy (an expected average of 3 months after admission)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia Exner, Prof. Dr. principal investigator
University of Leipzig
Winfried Rief, Prof. Dr. study director
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Therapy and Exposure and Response Prevention in people with Obsessive-Compulsive Disorder, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.