Obsessive Compulsive DisorderNCT02616341
Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder
A study testing Team ERP (T-ERP) Intervention and Treatment as Usual (TAU) in people with Obsessive Compulsive Disorder, run by Butler Hospital.
Trial summary
The overall aim of this study is to determine modifications to Exposure and Response Prevention (ERP) therapy that are needed in order to effectively deliver treatment for Obsessive Compulsive Disorder (OCD) in a community mental health center. 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?
- Team ERP (T-ERP) Intervention and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Feb 2016
- 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
- 18 Years to 65 Years
- English speaking
- Primary DSM-IV OCD (identified by the patient and therapist as the most problematic disorder over the past year)
- At least moderate severity OCD (YBOCS > 16)
- Not currently on psychotropic medications or on the same psychotropic medications for at least 4 weeks prior to screening
- Have never received 10 or more sessions of ERP
- Not currently attending psychotherapy for OCD
- Low-income based on the U.S. Housing and Urban Development (HUDs) threshold for RI (less than $41,000 per year for individuals).
Who cannot join
- Significant cognitive impairment (MMSE < 25)
- Prominent suicidal ideation
- Current psychosis, mania, alcohol or drug dependence as assessed by the SCID-P.
- Prominent Hoarding
About this study
The overall aim of this study is to determine modifications to Exposure and Response Prevention (ERP) therapy that are needed in order to effectively deliver treatment for Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP) intervention that will optimize therapist time by utilizing paraprofessionals to assist with group-ERP treatment plans. The intervention will be tailored to meet the unique needs of low-SES individuals with OCD and be implemented in a community mental health center (CMHC).
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Team ERP (T-ERP) Intervention, Treatment as Usual (TAU)
- 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.
Team ERP (T-ERP) InterventionBehavioural
Treatment as Usual (TAU)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Team ERP (T-ERP) Intervention | Experimental | The ERP team intervention (T-ERP) consists of 25 sessions over 20 weeks with four components: (a) 3-4 pretherapy individual session with therapist, (b) 12 weekly group sessions (90-mins) led by a therapist and, (c) 10 individual coaching sessions with a case manager during weeks 2-11 of the group, and (d) 2 booster group sessions to reinforce relapse prevention Receives: Behavioral: Team ERP (T-ERP) Intervention |
| Treatment as Usual (TAU) | Active comparator | Treatment as Usual (TAU) includes standard community treatment consisting of a personalized treatment plan and assistance with treatment referrals to available community resources Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in OCD symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: Baseline, 6th week of treatment, 12th week of treatment, 3 months post-treatment, 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2012
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Maria Mancebo, Ph.D., Principal investigator, Butler Hospital, Providence RI 02906
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616341
- Sponsor's protocol ID
- 1005-008
- Status last verified
- Aug 2017
- First submitted
- 18 Nov 2015
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02616341
- Acronym / sponsor ID
- 1005-008
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Nov 2015 (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 overall aim of this study is to determine modifications to Exposure and Response Prevention (ERP) therapy that are needed in order to effectively deliver treatment for Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP) intervention that will optimize therapist time by utilizing paraprofessionals to assist with group-ERP treatment plans. The intervention will be tailored to meet the unique needs of low-SES individuals with OCD and be implemented in a community mental health center (CMHC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Team ERP (T-ERP) Intervention | Experimental | Behavioral: Team ERP (T-ERP) InterventionThe ERP team intervention (T-ERP) consists of 25 sessions over 20 weeks with four components: (a) 3-4 pretherapy individual session with therapist, (b) 12 weekly group sessions (90-mins) led by a therapist and, (c) 10 individual coaching sessions with a case manager during weeks 2-11 of the group, and (d) 2 booster group sessions to reinforce relapse prevention |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Treatment as Usual (TAU) includes standard community treatment consisting of a personalized treatment plan and assistance with treatment referrals to available community resources |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 Years to 65 Years
- English speaking
- Primary DSM-IV OCD (identified by the patient and therapist as the most problematic disorder over the past year)
- At least moderate severity OCD (YBOCS > 16)
- Not currently on psychotropic medications or on the same psychotropic medications for at least 4 weeks prior to screening
Key exclusion criteria (4 listed)
- Significant cognitive impairment (MMSE < 25)
- Prominent suicidal ideation
- Current psychosis, mania, alcohol or drug dependence as assessed by the SCID-P.
- Prominent Hoarding
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 |
|---|---|---|
| Team ERP (T-ERP) Intervention | Behavioural | Team ERP (T-ERP) Intervention |
| Treatment as Usual (TAU) | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Changes in OCD symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Baseline, 6th week of treatment, 12th week of treatment, 3 months post-treatment, 6 months post-treatment
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 2017.
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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.
Maria Mancebo, Ph.D. principal investigator
Butler Hospital, Providence RI 02906
Questions about this trial
What is this clinical trial studying?
A study testing Team ERP (T-ERP) Intervention and Treatment as Usual (TAU) in people with Obsessive Compulsive Disorder, run by Butler Hospital.
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 8 inclusion and 4 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 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in OCD symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Baseline, 6th week of treatment, 12th week of treatment, 3 months post-treatment, 6 months post-treatment). 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 10 Aug 2017.