NCT01679457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

6.9 years

First QC Date

August 22, 2012

Last Update Submit

August 22, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Client Post-ERP Session Questions (Day 1).

    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).

    Client Post-ERP Session Questions (Day 2) will be administered immediately after the "Day 2" ACT-focused ERP session.

Study Arms (2)

ACT-Focused ERP

EXPERIMENTAL

One Session.

Behavioral: TAU-ERP

TAU-ERP

ACTIVE COMPARATOR

One Session.

Behavioral: ACT-Focused ERP

Interventions

ACT-Focused ERPBEHAVIORAL
TAU-ERP
TAU-ERPBEHAVIORAL
ACT-Focused ERP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obsessive Compulsive Disorder Institute at McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Nate G Gruner, LICSW

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Behavior Therapist

Study Record Dates

First Submitted

August 22, 2012

First Posted

September 6, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations