Recruiting

CBT for Anxiety

Sponsor:

Bradley Hospital

Code:

NCT06934525

Conditions

Obsessive Compulsive Disorder (OCD)

Pediatric Anxiety Disorders

Anxiety Disorder

Anxiety

OCD

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Team-delivered, exposure-based CBT

Study Details

Brief summary:

The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., social worker) who also provides weekly supervision for the exposure coach. This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom.

Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health.

The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.

Conditions

Obsessive Compulsive Disorder (OCD)

Pediatric Anxiety Disorders

Anxiety Disorder

Anxiety

OCD

Study ID

NCT06934525

Start date

Nov 1, 2025

Status verified date

May, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Feb 1, 2029

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
  • 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

501 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Flexible

Families and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis.

other: In-person

Families will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office.

other: Telehealth

Families will only attend sessions via a secure remote video platform.

Interventions

Team-delivered, exposure-based CBT

Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy

Primary outcome measure

  • Top Problems Assessment- Caregiver report [ Time Frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months) ]
  • Child Sheehan Disability Scale (CSDS)- caregiver report [ Time Frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months) ]

Central Contacts and Locations

Central contacts

Locations

Bradley Hospital

Recruiting

East Providence, Rhode Island, United States, 02915

Contacts

More Information

Sponsor

Bradley Hospital

Last update posted

Jul 31, 2026

Last verified

May, 2026

Keywords

  • exposure therapy
  • cognitive behavioral therapy
  • anxiety treatment
  • exposure and response prevention therapy
  • ERP
  • pediatric anxiety treatment

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 2026-07-31.