Obsessive-Compulsive Disorder (OCD)NCT02867449
Metacognitive Therapy for Obsessive-Compulsive Disorder
A study testing Metacognitive Therapy and Exposure and Response Prevention in people with Obsessive-Compulsive Disorder (OCD), run by University of Leipzig at 2 sites 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 (OCD)
- 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
- 74 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2016to Jan 2020
- 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
- Stable medication (at least 4 weeks)
Who cannot join
- Current or past diagnosis of substance dependence, psychosis, neurological conditions
- Mental retardation
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- 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 | Metacognitive Therapy for OCD according to Wells (1997) Receives: Behavioral: Metacognitive Therapy |
| Exposure and Response Prevention | Experimental | Exposure and Response Prevention for OCD according to Kozak \& Foa (1997) 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; Y-BOCS)
Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; Y-BOCS)
Measured: 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 outcomes (14)
Change in Symptom Severity (Padua Inventory; PI)
Change in Symptom Severity (Padua Inventory; PI)
Measured: 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 general psychopathology (Symptom Checklist-90-Revised, SCL-90-R)
Measured: 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 Metacognitions (Metacognitions Questionnaire, short version, MCQ-30)
Measured: 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 Obsessive Beliefs (Obsessive Beliefs Questionnaire, OBQ)
Measured: 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 Behavioral Avoidance (Behavioral Avoidance Test, BAT)
Measured: 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 Depression (Beck Depression Inventory, BDI-II)
Measured: 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 Anxiety (Beck Anxiety Inventory, BAI)
Measured: 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)
Change in Symptom Severity (Clinical Global Impressions; CGI)
Measured: 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 psychosocial functioning (Global Assessment of Functioning Scale, GAF)
Measured: 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)
Change in quality of life (The World Health Organization Quality of Life, WHOQOL_BREF)
Measured: 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)
Difference in efficiency (length of treatment)
documentation of number of sessions
Measured: immediately after completion of therapy (after an expected avarage of 12 weeks)
Difference in medical costs (based on the length of treatment)
Difference in medical costs (based on the length of treatment)
Measured: immediately after completion of therapy (after an expected avarage of 12 weeks)
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)
Measured: 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 satisfaction with the treatment
Difference in satisfaction with the treatment
Measured: immediately after completion of therapy (after an expected avarage of 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, German Research Foundation
- Responsible party
- Principal investigator, Cornelia Exner, University of Leipzig
- Investigators
- Cornelia Exner, Prof. Dr., Principal investigator, Leipzig UniversityJulia A. Glombiewski, Dr., Principal investigator, Philipps University MarburgAlexandra Kleiman, Dr., Study director, Leipzig UniversityAnke Haberkamp, Dr., Study director, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867449
- Sponsor's protocol ID
- MCT_OCD
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2016
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Exner C, Kleiman A, Haberkamp A, Hansmeier J, Milde C, Glombiewski JA. Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder - A non-inferiority randomized controlled trial. J Anxiety Disord. 2024 Jun;104:102873. doi: 10.1016/j.janxdis.2024.102873. Epub 2024 May 5.
PubMed 38729024
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Trial of Metacognitive Therapy Versus Exposure and Response Prevention for Individuals With Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02867449
- Acronym / sponsor ID
- MCT_OCD
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Philipps University Marburg, German Research Foundation
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 16 Aug 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy | Experimental | Behavioral: Metacognitive TherapyMetacognitive Therapy for OCD according to Wells (1997) |
| Exposure and Response Prevention | Experimental | Behavioral: Exposure and Response PreventionExposure and Response Prevention for OCD according to Kozak \& Foa (1997) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary diagnosis: obsessive-compulsive disorder
- German-speaking
- Agreeing to participate, verified by completion of informed consent
- Stable medication (at least 4 weeks)
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; 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)
14 secondary outcomes
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 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 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 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 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 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 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 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 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 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)
Difference in efficiency (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)
Time frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
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 satisfaction with the treatment
Time frame: immediately after completion of therapy (after an expected avarage of 12 weeks)
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 10 Aug 2026.
- Results publication: PubMed 38729024Exner C, Kleiman A, Haberkamp A, Hansmeier J, Milde C, Glombiewski JA. Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder - A non-inferiority randomized controlled trial. J Anxiety Disord. 2024 Jun;104:102873. doi: 10.1016/j.janxdis.2024.102873. Epub 2024 May 5.
- Individual participant dataSharing planned: Undecided
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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
Leipzig University
Julia A. Glombiewski, Dr. principal investigator
Philipps University Marburg
Alexandra Kleiman, Dr. study director
Leipzig University
2 sites 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 (OCD), run by University of Leipzig at 2 sites 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 4 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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; 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867449, which also lists 1 linked publication.
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 10 Aug 2026.