Obsessive-compulsive Disorders and SymptomsNCT01679457
Assessing Models of Exposure Therapy
A study testing ACT-Focused ERP and TAU-ERP in people with Obsessive-compulsive Disorders and Symptoms, run by Mclean Hospital at 1 site in United States.
Trial summary
The objective of this study is to learn how to improve treatment for clients who are working hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but who are not making the progress that would typically be expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-compulsive Disorders and Symptoms
- What is being tested?
- ACT-Focused ERP and TAU-ERP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be adults at least 18 years of age currently enrolled in the residential or day treatment program at the OCDI.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Obsessive Compulsive Disorder Institute at McLean Hospital
Belmont, Massachusetts, 02478
About this study
The objective of this study is to learn how to improve treatment for clients who are working hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but who are not making the progress that would typically be expected. Therefore, the investigators will be comparing the performance of such clients in a treatment as usual (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The investigators hypothesize that clients will perform significantly better in the ACT-focused ERP session than they will in the TAU-ERP session. More specifically, the investigators hypothesize that clients and an independent rater will report that in the ACT-focused ERP session, clients performed significantly fewer rituals and/or avoidance behaviors, experienced comparable levels of distress, exerted significantly more effort, had significantly less difficulty getting started with the ERP, were significantly less influenced by their uncomfortable thoughts/feelings, were significantly more willing to experience discomfort, were significantly more focused on working towards what is important to the client. The investigators also hypothesize that an independent rater will rate clients as significantly more compliant with the ACT-focused ERP session than with the TAU-ERP session. The investigators also hypothesize that clients will rate the ACT-focused ERP session as significantly more preferable and acceptable than the TAU-ERP session, and that they will report being significantly more willing to do the ACT-focused ERP session again.
- Being tested
- ACT-Focused ERP, TAU-ERP
- 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.
ACT-Focused ERPBehavioural
TAU-ERPBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ACT-Focused ERP | Experimental | One Session. Receives: Behavioral: TAU-ERP |
| TAU-ERP | Active comparator | One Session. Receives: Behavioral: ACT-Focused ERP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Post-ERP Session Questions (Day 1).
Measured: Client Post-ERP Session Questions (Day 1) will be administered immediately after the "Day 1" TAU-ERP session.
Client Post-ERP Session Questions (Day 2).
Measured: Client Post-ERP Session Questions (Day 2) will be administered immediately after the "Day 2" ACT-focused ERP session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive Disorders and SymptomsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Utah State University
- Responsible party
- Principal investigator, Nate Gruner, Mclean Hospital
- Investigators
- Nate G Gruner, LICSW, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679457
- Sponsor's protocol ID
- 2012-P-001010/1; McLean
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2012
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Models of Exposure Therapy
- ClinicalTrials.gov ID
- NCT01679457
- Acronym / sponsor ID
- 2012-P-001010/1; McLean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Utah State University
- Study start
- Sep 2012
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 6 Sep 2012 (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 objective of this study is to learn how to improve treatment for clients who are working hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but who are not making the progress that would typically be expected. Therefore, the investigators will be comparing the performance of such clients in a treatment as usual (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The investigators hypothesize that clients will perform significantly better in the ACT-focused ERP session than they will in the TAU-ERP session. More specifically, the investigators hypothesize that clients and an independent rater will report that in the ACT-focused ERP session, clients performed significantly fewer rituals and/or avoidance behaviors, experienced comparable levels of distress, exerted significantly more effort, had significantly less difficulty getting started with the ERP, were significantly less influenced by their uncomfortable thoughts/feelings, were significantly more willing to experience discomfort, were significantly more focused on working towards what is important to the client. The investigators also hypothesize that an independent rater will rate clients as significantly more compliant with the ACT-focused ERP session than with the TAU-ERP session. The investigators also hypothesize that clients will rate the ACT-focused ERP session as significantly more preferable and acceptable than the TAU-ERP session, and that they will report being significantly more willing to do the ACT-focused ERP session again.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-Focused ERP | Experimental | Behavioral: TAU-ERPOne Session. |
| TAU-ERP | Active comparator | Behavioral: ACT-Focused ERPOne Session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be adults at least 18 years of age currently enrolled in the residential or day treatment program at the OCDI.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ACT-Focused ERP | Behavioural | TAU-ERP |
| TAU-ERP | Behavioural | ACT-Focused ERP |
Primary outcome
Client Post-ERP Session Questions (Day 1).
Time frame: Client Post-ERP Session Questions (Day 1) will be administered immediately after the "Day 1" TAU-ERP session.
Client Post-ERP Session Questions (Day 2).
Time frame: Client Post-ERP Session Questions (Day 2) will be administered immediately after the "Day 2" ACT-focused ERP session.
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 25 Aug 2022.
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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.
Nate G Gruner, LICSW principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-Focused ERP and TAU-ERP in people with Obsessive-compulsive Disorders and Symptoms, run by Mclean Hospital 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 1 inclusion and 0 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 25 Aug 2022. 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.
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?
Client Post-ERP Session Questions (Day 1). (time frame: Client Post-ERP Session Questions (Day 1) will be administered immediately after the "Day 1" TAU-ERP session.). The study lists 2 primary outcomes in all. 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 25 Aug 2022.