Obsessive-Compulsive DisorderAug1NCT00045903
Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder
A study testing Exposure and Ritual Prevention (Cognitive Behavioral Therapy) and Stress Management Therapy (Cognitive Behavior Therapy) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in treating obsessive compulsive disorder (OCD) in patients who are taking medication but still have residual symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Exposure and Ritual Prevention (Cognitive Behavioral Therapy) and Stress Management Therapy (Cognitive Behavior Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2000to Jan 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obsessive-Compulsive Disorder (OCD) diagnosis
- Currently taking a serotonin reuptake inhibitor (SRI, i.e. clomipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) for OCD
Who cannot join
- Medical or psychiatric conditions that would make participation in the study hazardous
- Intensive cognitive-behavioral therapy while on an adequate dose and duration of an SRI for OCD
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiactic Institute, Anxiety Disorders Clinic
New York, New York, 10032
University of Pennsylvania Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104
About this study
Official title: CBT Augmentation for SRI Pharmacotherapy in OCD
This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in treating obsessive compulsive disorder (OCD) in patients who are taking medication but still have residual symptoms.
Read the detailed description
Participants remain on their current OCD medication and are randomly assigned to receive one of two CBTs: exposure and ritual prevention or stress management therapy. Exposure and ritual prevention involves imaginal and in-vivo exposure and requires that participants refrain from ritualizing. Stress management involves relaxation, assertiveness training, and structured problem-solving. Therapy occurs twice per week for 2 months. Participants are assessed verbally by an independent evaluator and are asked to complete self-rating forms. Patients who respond are followed for up to 1 additional year. Participants continue to take the same medication and the same monthly therapy for the first 6 months of follow-up. During the second 6 months of follow-up, participants discontinue therapy but continue taking the same medication.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00389493
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Exposure and Ritual Prevention (Cognitive Behavioral Therapy), Stress Management Therapy (Cognitive Behavior Therapy)
- Keywords
- Cognitive 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.
Exposure and Ritual Prevention (Cognitive Behavioral Therapy)Behavioural
Stress Management Therapy (Cognitive Behavior Therapy)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Exposure and Ritual Prevention | Experimental | Exposure and Ritual Prevention Therapy Receives: Behavioral: Exposure and Ritual Prevention (Cognitive Behavioral Therapy) |
| Stress Management | Active comparator | Stress Management Therapy Receives: Behavioral: Stress Management Therapy (Cognitive Behavior Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive symptoms measured at Month 2
Measured: 2 months
Secondary outcomes (1)
General functioning measured at Month 2
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2002 (estimated)
- Study startAug 2000
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael Liebowitz, MD, Principal investigator, New York State Psychiatric InstituteEdna Foa, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045903
- Sponsor's protocol ID
- IRB #4734R
- Other IDs
- R01MH045436-01, DSIR AT-CT
- Acronym
- Aug1
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2002
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.
PubMed 23945445Foa EB, Simpson HB, Liebowitz MR, Powers MB, Rosenfield D, Cahill SP, Campeas R, Franklin M, Hahn CG, Hembree EA, Huppert JD, Schmidt AB, Vermes D, Williams MT. Six-month follow-up of a randomized controlled trial augmenting serotonin reuptake inhibitor treatment with exposure and ritual prevention for obsessive-compulsive disorder. J Clin Psychiatry. 2013 May;74(5):464-9. doi: 10.4088/JCP.12m08017.
PubMed 23759449
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT Augmentation for SRI Pharmacotherapy in OCD
- ClinicalTrials.gov ID
- NCT00045903
- Acronym / sponsor ID
- Aug1 / IRB #4734R
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2000
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 17 Sep 2002 (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.
This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in treating obsessive compulsive disorder (OCD) in patients who are taking medication but still have residual symptoms.
Detailed description
Participants remain on their current OCD medication and are randomly assigned to receive one of two CBTs: exposure and ritual prevention or stress management therapy. Exposure and ritual prevention involves imaginal and in-vivo exposure and requires that participants refrain from ritualizing. Stress management involves relaxation, assertiveness training, and structured problem-solving. Therapy occurs twice per week for 2 months. Participants are assessed verbally by an independent evaluator and are asked to complete self-rating forms. Patients who respond are followed for up to 1 additional year. Participants continue to take the same medication and the same monthly therapy for the first 6 months of follow-up. During the second 6 months of follow-up, participants discontinue therapy but continue taking the same medication.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00389493
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure and Ritual Prevention | Experimental | Behavioral: Exposure and Ritual Prevention (Cognitive Behavioral Therapy)Exposure and Ritual Prevention Therapy |
| Stress Management | Active comparator | Behavioral: Stress Management Therapy (Cognitive Behavior Therapy)Stress Management Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obsessive-Compulsive Disorder (OCD) diagnosis
- Currently taking a serotonin reuptake inhibitor (SRI, i.e. clomipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) for OCD
Key exclusion criteria (2 listed)
- Medical or psychiatric conditions that would make participation in the study hazardous
- Intensive cognitive-behavioral therapy while on an adequate dose and duration of an SRI for OCD
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 |
|---|---|---|
| Exposure and Ritual Prevention (Cognitive Behavioral Therapy) | Behavioural | Exposure and Ritual Prevention |
| Stress Management Therapy (Cognitive Behavior Therapy) | Behavioural | Stress Management |
Primary outcome
Obsessive-compulsive symptoms measured at Month 2
Time frame: 2 months
1 secondary outcome
General functioning measured at Month 2
Time frame: 2 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 23 Apr 2014.
- Derived from this study: PubMed 23945445Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.
- Derived from this study: PubMed 23759449Foa EB, Simpson HB, Liebowitz MR, Powers MB, Rosenfield D, Cahill SP, Campeas R, Franklin M, Hahn CG, Hembree EA, Huppert JD, Schmidt AB, Vermes D, Williams MT. Six-month follow-up of a randomized controlled trial augmenting serotonin reuptake inhibitor treatment with exposure and ritual prevention for obsessive-compulsive disorder. J Clin Psychiatry. 2013 May;74(5):464-9. doi: 10.4088/JCP.12m08017.
Related trials for Obsessive-Compulsive Disorder
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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.
Michael Liebowitz, MD principal investigator
New York State Psychiatric Institute
Edna Foa, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and Ritual Prevention (Cognitive Behavioral Therapy) and Stress Management Therapy (Cognitive Behavior Therapy) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
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 2 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 23 Apr 2014. 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 United States. 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?
Obsessive-compulsive symptoms measured at Month 2 (time frame: 2 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 NCT00045903, which also lists 2 linked publications.
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 23 Apr 2014.