Obsessive-Compulsive DisorderPhase 1NCT00316316
Cognitive Behavioral Therapy Plus Motivational Interviewing for Treatment of Obsessive-Compulsive Disorder
A Phase 1 study testing Motivational interviewing plus exposure and response prevention (MI plus EX/RP) and Exposure and response prevention (EX/RP) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will determine the effectiveness of adding motivational interviewing to cognitive behavioral therapy, consisting of exposure and ritual prevention, in improving treatment outcomes in people with obsessive-compulsive disorder. 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?
- Motivational interviewing plus exposure and response prevention (MI plus EX/RP) and Exposure and response prevention (EX/RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2010
- Phase
- Phase 1
- 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
- Primary diagnosis of OCD as defined by DSM-IV
- Obsessions and/or compulsions must have been present for at least one year
- At pre-treatment, a minimum on Y-BOCS on items 1-10 of 16
- If on psychiatric medication, patient has been on stable SRI dose for a minimum of 12 weeks (and four weeks for concomitant OCD meds,e.g., benzos and antipsychotics) and plans to remain on a stable dose for the duration of the EX/RP+MI treatment.
- Able to provide informed consent
- No prior adequate EX/RP treatment (defined as at least 8 exposure sessions that include response prevention instructions and between sessions assignments in a 2 month period)
- Based on hx, subject is unlikely to require a change in med during the course of EX/RP/EX/RP+MI treatment
Who cannot join
- Any additional medical or psychiatric conditions that could make participation in the study medically inadvisable
- Currently receiving psychotherapy at another clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Cognitive Behavioral Therapy Plus Motivational Interviewing for Obsessive Compulsive Disorder
This study will determine the effectiveness of adding motivational interviewing to cognitive behavioral therapy, consisting of exposure and ritual prevention, in improving treatment outcomes in people with obsessive-compulsive disorder.
Read the detailed description
Obsessive Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, or obsessions. Some examples of obsessions include the following: repetitive fears of causing harm or being harmed; fears of contamination and illness; fears of making mistakes; intrusive distressing sexual or religious imagery; and fears of losing things. In an effort to relieve anxiety about these obsessions, people with OCD develop repetitive behaviors called compulsions. Some examples of compulsions include the following: repetitive washing and cleaning; excessive checking; excessive ordering and arranging; and extreme hoarding and saving. These thoughts and behaviors interfere with everyday life to a great extent. Cognitive behavior therapy (CBT) with exposure and ritual prevention (EX/RP) is a standard treatment for OCD. EX/RP involves both imaginary and real exposure to situations or settings that may stimulate OCD behavior, and it requires that patients refrain from ritualizing. Motivational interviewing (MI) may help to enhance an individual's motivation to change by exploring and resolving ambivalence. This study will determine the effectiveness of adding MI to CBT that consists of EX/RP in improving treatment outcome in people with OCD.
Participants in this single-blind study will be randomly assigned to receive either standard CBT with EX/RP or CBT with EX/RP plus MI. All participants will report to the study site twice weekly for both therapy and assessments for a total of 2 months. Assessments will include interviews and self-rating forms. No medication will be administered during this study. However, participants will continue on any medication that they are taking at the time of study entry. All participants will be assessed for outcomes upon study completion. Participants who respond to therapy will be assessed again 6 months following study completion.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Motivational interviewing plus exposure and response prevention (MI plus EX/RP), Exposure and response prevention (EX/RP)
- Keywords
- OCD
- 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.
Motivational interviewing plus exposure and response prevention (MI plus EX/RP)Behavioural
Also called MI plus EX/RP
Participants will receive 18 sessions of MI plus EX/RP.
Exposure and response prevention (EX/RP)Behavioural
Also called EX/RP
Participants will receive 18 sessions of EX/RP.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive motivational interviewing plus exposure and response prevention Receives: Behavioral: Motivational interviewing plus exposure and response prevention (MI plus EX/RP) |
| 2 | Active comparator | Participants will receive exposure and response prevention only Receives: Behavioral: Exposure and response prevention (EX/RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive symptoms
Measured: Measured at Months 2 and 8
Secondary outcomes (1)
Adherence, depression, insight, and quality of life
Measured: Measured at Months 2 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2010
- Study completionMar 2010
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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
- Helen Blair Simpson, MD, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316316
- Sponsor's protocol ID
- #5124
- Other IDs
- R34MH071570, DAHBR 96-BHA
- Status last verified
- Mar 2012
- First submitted
- 18 Apr 2006
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
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 23945445
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy Plus Motivational Interviewing for Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00316316
- Acronym / sponsor ID
- #5124
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Apr 2006 (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 determine the effectiveness of adding motivational interviewing to cognitive behavioral therapy, consisting of exposure and ritual prevention, in improving treatment outcomes in people with obsessive-compulsive disorder.
Detailed description
Obsessive Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, or obsessions. Some examples of obsessions include the following: repetitive fears of causing harm or being harmed; fears of contamination and illness; fears of making mistakes; intrusive distressing sexual or religious imagery; and fears of losing things. In an effort to relieve anxiety about these obsessions, people with OCD develop repetitive behaviors called compulsions. Some examples of compulsions include the following: repetitive washing and cleaning; excessive checking; excessive ordering and arranging; and extreme hoarding and saving. These thoughts and behaviors interfere with everyday life to a great extent. Cognitive behavior therapy (CBT) with exposure and ritual prevention (EX/RP) is a standard treatment for OCD. EX/RP involves both imaginary and real exposure to situations or settings that may stimulate OCD behavior, and it requires that patients refrain from ritualizing. Motivational interviewing (MI) may help to enhance an individual's motivation to change by exploring and resolving ambivalence. This study will determine the effectiveness of adding MI to CBT that consists of EX/RP in improving treatment outcome in people with OCD.
Participants in this single-blind study will be randomly assigned to receive either standard CBT with EX/RP or CBT with EX/RP plus MI. All participants will report to the study site twice weekly for both therapy and assessments for a total of 2 months. Assessments will include interviews and self-rating forms. No medication will be administered during this study. However, participants will continue on any medication that they are taking at the time of study entry. All participants will be assessed for outcomes upon study completion. Participants who respond to therapy will be assessed again 6 months following study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Motivational interviewing plus exposure and response prevention (MI plus EX/RP)Participants will receive motivational interviewing plus exposure and response prevention |
| 2 | Active comparator | Behavioral: Exposure and response prevention (EX/RP)Participants will receive exposure and response prevention only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary diagnosis of OCD as defined by DSM-IV
- Obsessions and/or compulsions must have been present for at least one year
- At pre-treatment, a minimum on Y-BOCS on items 1-10 of 16
- If on psychiatric medication, patient has been on stable SRI dose for a minimum of 12 weeks (and four weeks for concomitant OCD meds,e.g., benzos and antipsychotics) and plans to remain on a stable dose for the duration of the EX/RP+MI treatment.
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Any additional medical or psychiatric conditions that could make participation in the study medically inadvisable
- Currently receiving psychotherapy at another clinic
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 |
|---|---|---|
| Motivational interviewing plus exposure and response prevention (MI plus EX/RP)Also: MI plus EX/RPParticipants will receive 18 sessions of MI plus EX/RP. | Behavioural | 1 |
| Exposure and response prevention (EX/RP)Also: EX/RPParticipants will receive 18 sessions of EX/RP. | Behavioural | 2 |
Primary outcome
Obsessive-compulsive symptoms
Time frame: Measured at Months 2 and 8
1 secondary outcome
Adherence, depression, insight, and quality of life
Time frame: Measured at Months 2 and 8
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 16 Mar 2012.
- 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.
- Click here for the Obsessive-Compulsive Disorder Research Clinic website.Link provided by the sponsor.
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.
Helen Blair Simpson, MD, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motivational interviewing plus exposure and response prevention (MI plus EX/RP) and Exposure and response prevention (EX/RP) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site 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 7 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 16 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: Measured at Months 2 and 8). 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 NCT00316316, 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 16 Mar 2012.