Obsessive-Compulsive DisorderNCT00184262
Exposure and Response Prevention With Behavioral- Versus Cognitive Therapy Rationale in Obsessive Compulsive Disorder
A study testing ERP cognitive therapy and ERP behavioral therapy in people with Obsessive-Compulsive Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of the study is to determine whether exposure and response prevention (ERP) is more effective when patients are presented with a behavioral therapy versus cognitive therapy rationale in the treatment of obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- ERP cognitive therapy and ERP behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2003to Dec 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obsessive-compulsive disorder
Who cannot join
- active thought disorder, uncontrolled bipolar disorder, mental retardation, organic mental disorder, initiation or change in medication three months prior to inclusion in the study
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology, INM
Trondheim, 7441
About this study
Official title: Exposure and Response Prevention (ERP) With Behavioral- Versus Cognitive Therapy Rationale in the Treatment of OCD
The aim of the study is to determine whether exposure and response prevention (ERP) is more effective when patients are presented with a behavioral therapy versus cognitive therapy rationale in the treatment of obsessive-compulsive disorder (OCD).
Read the detailed description
The aim of the study is to determine whether exposure and response prevention (ERP) is more effective when patients are presented with a behavioral therapy versus cognitive therapy rationale in the treatment of obsessive-compulsive disorder OCD.
A randomized controlled trial including patients with OCD. 50 patients will receive 15 ERP sessions in 3 months.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- ERP cognitive therapy, ERP behavioral therapy
- 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.
ERP cognitive therapyBehavioural
Also called exposure and response prevention + cognitive therapy
15 exposure and response prevention (ERP) sessions in 3 months with a cognitive therapy rationale
ERP behavioral therapyBehavioural
Also called exposure and response prevention + behavioral therapy
15 exposure and response prevention (ERP) sessions in 3 months with a behavioral therapy rationale
| Study group | Role | What they receive |
|---|---|---|
| ERP cognitive therapy | Active comparator | Not described Receives: Behavioral: ERP cognitive therapy |
| ERP behavioral therapy | Experimental | Not described Receives: Behavioral: ERP behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
scores on Y-BOCS and SCID-I
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2003
- Study completionDec 2006
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 DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- K. Gunnar Götestam, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184262
- Sponsor's protocol ID
- 4941.1
- Status last verified
- Mar 2012
- First submitted
- 13 Sep 2005
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen B, Vogel PA, Stiles TC, Gotestam KG. Influence of co-morbid generalized anxiety disorder, panic disorder and personality disorders on the outcome of cognitive behavioural treatment of obsessive-compulsive disorder. Cogn Behav Ther. 2007;36(3):145-55. doi: 10.1080/16506070701259374.
PubMed 17943480
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure and Response Prevention (ERP) With Behavioral- Versus Cognitive Therapy Rationale in the Treatment of OCD
- ClinicalTrials.gov ID
- NCT00184262
- Acronym / sponsor ID
- 4941.1
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Study start
- Jan 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Sep 2005 (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.
The aim of the study is to determine whether exposure and response prevention (ERP) is more effective when patients are presented with a behavioral therapy versus cognitive therapy rationale in the treatment of obsessive-compulsive disorder (OCD).
Detailed description
The aim of the study is to determine whether exposure and response prevention (ERP) is more effective when patients are presented with a behavioral therapy versus cognitive therapy rationale in the treatment of obsessive-compulsive disorder OCD.
A randomized controlled trial including patients with OCD. 50 patients will receive 15 ERP sessions in 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERP cognitive therapy | Active comparator | Behavioral: ERP cognitive therapy |
| ERP behavioral therapy | Experimental | Behavioral: ERP behavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obsessive-compulsive disorder
Key exclusion criteria (1 listed)
- active thought disorder, uncontrolled bipolar disorder, mental retardation, organic mental disorder, initiation or change in medication three months prior to inclusion in the study
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 |
|---|---|---|
| ERP cognitive therapyAlso: exposure and response prevention + cognitive therapy15 exposure and response prevention (ERP) sessions in 3 months with a cognitive therapy rationale | Behavioural | ERP cognitive therapy |
| ERP behavioral therapyAlso: exposure and response prevention + behavioral therapy15 exposure and response prevention (ERP) sessions in 3 months with a behavioral therapy rationale | Behavioural | ERP behavioral therapy |
Primary outcome
scores on Y-BOCS and SCID-I
Time frame: 3 months
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 21 Mar 2012.
- Results publication: PubMed 17943480Hansen B, Vogel PA, Stiles TC, Gotestam KG. Influence of co-morbid generalized anxiety disorder, panic disorder and personality disorders on the outcome of cognitive behavioural treatment of obsessive-compulsive disorder. Cogn Behav Ther. 2007;36(3):145-55. doi: 10.1080/16506070701259374.
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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.
K. Gunnar Götestam, PhD MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERP cognitive therapy and ERP behavioral therapy in people with Obsessive-Compulsive Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 21 Mar 2012. 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 Norway. 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?
scores on Y-BOCS and SCID-I (time frame: 3 months). 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 NCT00184262, 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 21 Mar 2012; AzTrials last refreshed its copy on 1 Nov 2026.