Recruiting

Observational Study

Sponsor:

Bradley Hospital

Code:

NCT03528109

Conditions

Obsessive-Compulsive Disorder

Anxiety Disorders

Pediatric Disorder

Anxiety

OCD

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Exposure Therapy

Study Details

Brief summary:

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

Conditions

Obsessive-Compulsive Disorder

Anxiety Disorders

Pediatric Disorder

Anxiety

OCD

Study ID

NCT03528109

Start date

Jul 1, 2018

Status verified date

Aug, 2022

Completion date

Feb 1, 2025

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 5-18 inclusive
  • primary or co-primary DSM-V diagnosis of anxiety or OCD
  • symptom duration of at least 3 months
  • outpatient care needed
  • presence of a stable parent, or guardian, who can participate in treatment

Exclusion Criteria:

  • other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
  • documented mental retardation
  • thought disorder or psychotic symptoms
  • conduct disorder
  • acute suicidality
  • concurrent psychotherapy
  • chronic medical illness that would preclude their active participation in treatment
  • treatment with psychotropic medication that is not stable

Study Design

Enrollment

379 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: patient-centered home CBT

60 minute office-based exposure therapy with a PhD psychologist once per month and a 90 minute community-based CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week)

active comparator: Provider-centered

60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)

experimental: patient-centered telehealth CBT

60 minute telehealth exposure therapy with a PhD psychologist once per month and a 90 minute telehealth CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week). Patient-centered telehealth was closed when the recruitment goal was met in May 2021.

Interventions

Exposure Therapy

A type of Cognitive Behavioral Therapy shown to be effective in the treatment of pediatric OCD and anxiety

Primary outcome measure

  • Children's Yale-Brown Obsessive-Compulsive Scale [ Time Frame: In-treatment and follow-up (6-12 months) ]
  • Pediatric Anxiety Rating Scale [ Time Frame: In-treatment and follow-up (6-12 months) ]

Central Contacts and Locations

Central contacts

Locations

Bradley Hospital

Recruiting

Riverside, Rhode Island, United States, 02915

Contacts

More Information

Sponsor

Bradley Hospital

Last update posted

Aug 3, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bradley Hospital on 2022-08-03.