Quality Assessment in Exposure Therapy

NCT03182101 | Unknown DMC

• 1 other identifier: 1039342
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

This project will test a measure of treatment quality, Exposure Guide, for therapists using exposure therapy for youths and young adults with anxiety or OCD. We anticipate that users of this measure will be able to complete it reliably, find it acceptable, and that the measure will predict patient outcome. This project will include 40 therapists treating 300 anxious youth and young adults ages 5-25 at a large community mental health agency. Results of this study will establish the Exposure Guide as a measure of exposure quality in real world settings.

Conditions

Obsessive-Compulsive Disorder in Children

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Scales

  The Clinical Global Impression Scales (CGI) are brief, clinician-rated measures of global severity and improvement in treatment for children and adults.

  Through study completion, an average of 6 months

Study Arms (1)

Exposure Therapy with fidelity checklist

EXPERIMENTAL

Therapist and parent/child participants will complete an Exposure Guide after each session.

Behavioral: Exposure Therapy

Interventions

Exposure Therapy BEHAVIORAL

Exposure Therapy is a form of Cognitive Behavioral Therapy. There is strong evidence for exposure as a necessary and primary ingredient for treating anxiety and OCD, and exposure is the most common practice element in treatment protocols for anxiety.

Exposure Therapy with fidelity checklist

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient at a Community Mental Health Agency that is partnering with this study
• Primary or co-primary diagnosis of OCD, Separation Anxiety, Social Anxiety, Panic Disorder, or Specific Phobia.
• Children \< age 12 have a caretaker available to participate in treatment
• Patient and parent/legal guardian are English speaking

You may not qualify if:

• Concurrent psychotherapy for treatment of anxiety
• Psychosis, Pervasive Developmental Disorder, or Mental Retardation

Sponsors & Collaborators

• Bradley Hospital: lead

Study Sites (1)

Emma Pendleton Bradley Hospital

Riverside, Rhode Island, 02915, United States

Location

MeSH Terms

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kristen Benito, PhD

  The Warren Alpert Medical School of Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 9, 2017
• Study Start: September 13, 2017
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Secondary outcome data will be uploaded biannually beginning in January of 2018. Primary outcomes will be made available within 6 months of study completion.

Locations

US (1)