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

NCT03672565 | Completed

• 1 other identifier: H18-01654
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exposure and Response prevention ERP; Cognitive-behavioural therapy; Pediatric OCD; Childhood-onset OCD

Outcome Measures

Primary Outcomes (3)

• Change in OCD symptom severity (i.e., percentage of youth achieving remission) following Treatment Phase One both within and between treatment settings (hospital vs. community)

  OCD symptom severity is measured with Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), a clinician-rated scale of 10 items, each rated from 0 (no symptoms) to 4 (extreme symptoms), scores are summed to give a maximum score of 40. Higher scores indicate worse symptomatology. Youth will be identified as in remission if they are rated as having a total score of 11 (out of 40) or lower on the CY-BOCS at post-treatment assessment 1.

  Baseline Assessment (Week1/Day1), Post-treatment Assessment 1 (Week3/Day14)

• Change in OCD symptom severity between pre- and post-treatment for both treatment phases both within and between treatment settings

  OCD symptom severity is measured with Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), a clinician-rated scale of 10 items, each rated from 0 (no symptoms) to 4 (extreme symptoms), scores are summed to give a maximum score of 40. Higher scores indicate worse symptomatology. Phase one pre- and post-treatment is assessed at Baseline assessment (BA) and PA1 while phase two pre- and post-treatment is assessed at Treatment Decision Point (TDP) and Post-treatment assessment 2 (PA2).

  Phase 1: BA (Week1/Day1), PA1 (Week3/Day14) | Phase 2: TDP (weeks4-9/days18,25,32,39,46,53), PA2 (Week4-10/Day21,28,35,42,49,or60)

• Number of sessions utilized by families used within treatment phase two both within and between treatment settings

  Following treatment phase one, families will decide between the following options at Treatment Decision Points (TDP): A) The family may select that they would like to receive and complete the next ERP session and can select to receive up to four additional 3-hour ERP sessions during Treatment Phase Two. B) The family may opt to delay receiving a treatment session by one week for any reason (e.g., prior engagement/holiday, additional time to evaluate symptoms). Families will be allowed to take a week off up to two times during Treatment Phase Two. C) The family may select to end their participation in Treatment Phase Two at any decision point and for any reason (e.g., don't perceive it as helpful, have improved substantially, have already utilized two weeks off and do not wish to have an additional session).

  TDP (Weeks4-9/Day18,25,32,39,46,or53)

Secondary Outcomes (2)

• Patient satisfaction and treatment tolerability

  Treatment expectancy at Baseline Assessment; treatment perspectives at one-month follow-up following treatment completion

• Cost-effectiveness

  After study completion

Study Arms (2)

Hospital setting

ACTIVE COMPARATOR

ERPs may be conducted in various settings on hospital grounds (e.g., cafeteria, hallways) but will not be conducted off property.

Behavioral: Phase One: Standardized Brief Intensive ERP; Behavioral: Phase Two: Flexible Patient Driven Intensive ERP; Behavioral: Follow-Up Phase: Booster Calls

Community setting

ACTIVE COMPARATOR

Community ERP sessions will be conducted locations deemed most relevant to the child's symptom presentation such as in the home or at other community locations (e.g., church, downtown).

Behavioral: Phase One: Standardized Brief Intensive ERP; Behavioral: Phase Two: Flexible Patient Driven Intensive ERP; Behavioral: Follow-Up Phase: Booster Calls

Interventions

Phase One: Standardized Brief Intensive ERP BEHAVIORAL

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.

Community setting; Hospital setting

Phase Two: Flexible Patient Driven Intensive ERP BEHAVIORAL

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).

Community setting; Hospital setting

Follow-Up Phase: Booster Calls BEHAVIORAL

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.

Community setting; Hospital setting

Eligibility Criteria

• Age: 7 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be between the ages of 7 - 19 years
• Have a primary diagnosis of OCD
• Have a score of equal to, or greater than, 16 on the Children's Yale - Brown Obsessive Compulsive Scale
• Be, and have a parent/guardian, willing to participate in treatment
• Be stable on psychotropic medication as demonstrated by at least 10 weeks since first initiation of an serotonin reuptake inhibitor (SRI) and 4 weeks since initiation of any other psychotropic medications as well as 4 weeks since any dose adjustment of any psychotropic medications.
• Have sufficient English capabilities to complete questionnaires
• Live within the Greater Vancouver Area (within approximately 60 minutes drive of BC Children's Hospital)

You may not qualify if:

• Meet diagnostic criteria for bipolar disorder, psychosis, intellectual disability, substance dependence/abuse, or autism spectrum disorder (\> level 1 impairment)
• Demonstrate alternate psychiatric symptoms of a more pressing nature than the OCD symptoms (e.g. suicidal intent in the context of comorbid depression)
• Youth or parents refusing to engage in treatment
• Initiation of an antidepressant within 10 weeks or an alternate psychotropic medication within 4 weeks or adjusted dosage within 4 weeks
• Family lives outside of the Greater Vancouver Area (longer than 60 minutes drive of BC Children's Hospital)

Sponsors & Collaborators

• University of British Columbia: lead
• Michael Smith Foundation for Health Research: collaborator

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Selles RR, Naqqash Z, Best JR, Franco-Yamin D, Qiu ST, Ferreira JS, Deng X, Hannesdottir DK, Oberth C, Belschner L, Negreiros J, Farrell LJ, Stewart SE. Effects of Treatment Setting on Outcomes of Flexibly-Dosed Intensive Cognitive Behavioral Therapy for Pediatric OCD: A Randomized Controlled Pilot Trial. Front Psychiatry. 2021 May 17;12:669494. doi: 10.3389/fpsyt.2021.669494. eCollection 2021.

  PMID: 34079488 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Evelyn S. Stewart, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: October 1, 2018
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

CA (1)