SMART ERP for the Behavioral Treatment of Youth With Obsessive Compulsive Disorder (OCD)

NCT03672565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-09-30

No results posted yet for this study

Summary

This randomized pilot study examines a graduated behavioral treatment approach for youth with obsessive compulsive disorder. Youth will be randomized to receive treatment in the community or at the hospital. In the first stage, youth receive an intro session and two 3-hour ERP sessions. Youth will be assessed for OCD recovery. Recovered youth enter follow-up. Still affected youth enter the second stage, where they will can select to receive up to four additional ERP sessions (one per week). In follow-up, youth will receive three 30 minute weekly calls and will be reassessed at 1- and 6-months following treatment.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

BEHAVIORAL

Phase One: Standardized Brief Intensive ERP

Participants will be randomized to receive ERP sessions at the hospital or at relevant community locations. In the introductory session, participants will be provided with psychoeducation about OCD and the treatment model, will develop a list of potential exposures, and will attempt initial exposure and response prevention (ERP) exercises. The session will end with an assignment of ERP homework. In the seven days following the introductory session, youth and parents will receive two 3-hour sessions, separated by a three day break. The sessions will begin with a brief review of homework completion and success. Following this, with parent observation, the clinician will guide the youth through escalating ERP exercises. The session will end with ERP homework planning. Other evidence-based treatment strategies (e.g., addressing motivation, discussing parental accommodations) may be implemented as deemed necessary by the clinician in order to encourage effective engagement in ERP exercises.

BEHAVIORAL

Phase Two: Flexible Patient Driven Intensive ERP

Families will have the opportunity to access up to four additional once/week 3-hour intensive ERP sessions. Three days prior to each additional ERP session (sessions 3-6), families will be prompted to fill out online forms and decide how to proceed with treatment for that week with the following options: * They may select that they would like to receive and complete the next ERP session, and up to four 3-hour ERP sessions during Phase Two. Completion of all four ERP session will automatically end Phase Two. * They may opt to delay receiving a treatment session by one week for any reason. Families will be allowed to take a week off up to two times during Phase Two. If both weeks off are utilized, at the next decision point families must either opt to complete an ERP Session or end their participation in Phase Two. * They may select to end their participation in Phase Two at any decision point and for any reason (e.g., don't perceive it as helpful, have improved substantially).

BEHAVIORAL

Follow-Up Phase: Booster Calls

Upon achieving remission at any remission assessment or completion of remission assessment five, youth will enter the follow-up phase. Youth will receive three weekly 30 minute post-treatment booster phone calls. Calls will focus on homework completion, ERP planning, and relapse prevention skills.

Sponsors & Collaborators

  • Michael Smith Foundation for Health Research

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Evelyn S. Stewart, MD · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-08-27
Completion
2021-08-27

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672565 on ClinicalTrials.gov