Clinical trial NCT03672565: SMART ERP for the Behavioral Treatment of Youth With Obsessive Compulsive Disorder (OCD)
Official title: Flexibly Dosed Intensive Exposure and Response Prevention as a Means to Maximize Outcomes for Youth With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Exposure and Response prevention ERP
Cognitive-behavioural therapy
Pediatric OCD
Childhood-onset OCD
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Michael Smith Foundation for Health Research
First posted: 2018-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Obsessive compulsive disorder (OCD) is a highly debilitating psychiatric disorder that affects many youth. Despite strong empirical support that exposure and response prevention (ERP) is an efficacious and tolerable treatment of pediatric OCD including when presented in intensive formats, most individuals simply do not access or receive this treatment.

The dissemination of efficient interventions is of high public health priority, and graduated, or stepped care, models may be the answer. However, initial interventions within a graduated approach must be appropriate for the severity of the condition, given that unnecessary delays to an optimal dose may result in escalating burden on families and ultimately health services. Indeed, low intensity online CBT and self-help have so far had limited efficacy with less than one third of patients deemed responsive to treatment.

In contrast, brief intensive ERP is likely an efficient and effective alternative to flexibly dosing the level of intervention to the participant's needs. In fact, a recent pilot study (n = 10) providing two 3-hour ERP sessions to youth with OCD observed 60% post-treatment, and 70% 6-month follow-up, remission rates among participants. Extending on this study's findings, by utilizing more conservative remission criteria and providing access to additional doses of intensive ERP to youth not yet achieving remission, holds promise in identifying the level of services utilized by families to achieve meaningful treatment outcomes.

Above and beyond the use of a graduated dose model, many questions remain regarding optimal implementation methods for the behavioral treatment of pediatric OCD. In particular, the impact of treatment setting (i.e. community versus clinic) on response has not been systematically studied within this population. Given increased setting relevance and opportunity for in vivo learning, community exposures may be expected to be more effective; however, as they are associated with additional challenges (e.g., transportation time), their contribution to improvement needs to be directly verified and weighed against these costs.

Therefore, the present study seeks to determine the feasibility of implementing a sequential, multiple assignment, randomized trial (SMART) for the behavioral treatment of youth with OCD. The study focuses on evaluating the benefits from a minimum initial dose of intensive exposure and response prevention (ERP) as well as the demand for, and benefits from, additional ERP sessions by still-affected OCD families. In addition, via randomization, the study examines the influence of treatment setting (community vs hospital) on response. Primary outcomes include the impact of treatment on symptom severity and other relevant clinical outcomes (e.g., quality of life, youth- and family-functioning) as well as patient decisions/treatment utilization. Participant perspectives on study/treatment procedures (e.g., acceptability, optimal components) as well as cost-effectiveness (e.g., travel expenses, staff time, service utilization) will also be recorded.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 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)
timeFrame: Baseline Assessment (Week1/Day1), Post-treatment Assessment 1 (Week3/Day14)
measure: Change in OCD symptom severity between pre- and post-treatment for both treatment phases both within and between treatment settings
timeFrame: 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)
measure: Number of sessions utilized by families used within treatment phase two both within and between treatment settings
timeFrame: TDP (Weeks4-9/Day18,25,32,39,46,or53)
Secondary outcomes:
measure: Patient satisfaction and treatment tolerability
timeFrame: Treatment expectancy at Baseline Assessment; treatment perspectives at one-month follow-up following treatment completion
measure: Cost-effectiveness
timeFrame: After study completion
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: Study Principal Investigator
name: Evelyn S. Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.