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Assessing Models of Exposure Therapy

Primary Purpose

Obsessive-compulsive Disorders and Symptoms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ACT-Focused ERP

TAU-ERP

About this trial

This is an interventional treatment trial for Obsessive-compulsive Disorders and Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants will be adults at least 18 years of age currently enrolled in the residential or day treatment program at the OCDI.

Sites / Locations

Obsessive Compulsive Disorder Institute at McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT-Focused ERP

TAU-ERP

Arm Description

One Session.

Outcomes

Primary Outcome Measures

Client Post-ERP Session Questions (Day 1).

Client Post-ERP Session Questions (Day 2).

Secondary Outcome Measures

Full Information

NCT ID

NCT01679457

First Posted

August 22, 2012

Last Updated

August 22, 2022

Sponsor

Mclean Hospital

Collaborators

Utah State University

1. Study Identification

Unique Protocol Identification Number

NCT01679457

Brief Title

Assessing Models of Exposure Therapy

Official Title

Assessing Models of Exposure Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

August 2019 (Actual)

Study Completion Date

August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

Collaborators

Utah State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-compulsive Disorders and Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACT-Focused ERP

Arm Type

Experimental

Arm Description

One Session.

Arm Title

TAU-ERP

Arm Type

Active Comparator

Arm Description

One Session.

Intervention Type

Behavioral

Intervention Name(s)

ACT-Focused ERP

Intervention Type

Behavioral

Intervention Name(s)

TAU-ERP

Primary Outcome Measure Information:

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants will be adults at least 18 years of age currently enrolled in the residential or day treatment program at the OCDI.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nate G Gruner, LICSW

Organizational Affiliation

Mclean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Obsessive Compulsive Disorder Institute at McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

12. IPD Sharing Statement

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Assessing Models of Exposure Therapy

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