Quality Assessment in Exposure Therapy

Obsessive-Compulsive Disorder in Children Clinical Trial

Official title:

Quality Assessment in Exposure Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03182101
• Other study ID #: 1039342
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Bradley Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Empirically supported behavioral treatments cannot be effectively disseminated without understanding key quality components. Mechanism-informed quality measures have extraordinary potential to enhance pragmatism by eliminating unnecessary elements and targeting multiple problems and populations, and to enhance predictive value by detecting mechanism engagement early in treatment. Community Mental Health Agencies (CMHAs), however, are often ill-equipped to use such measures of treatment quality due to burden and limited resources. Exposure therapy for anxiety is an ideal prototype for testing a practical, mechanism-informed quality measure in CMHAs given its potential for public health impact and clear theory of mechanism. The Exposure Guide (EG), a brief quality tool measuring therapist behaviors and mechanism, was developed based on microanalytic coded data showing a strong link between therapist behavior and patient outcome across three RCTs of exposure therapy in youth. Initial psychometrics for the EG using these RCT data are promising showing reliability, construct validity, and predictive validity, and pilot data suggests it may be acceptable and feasible in a community setting. Building upon these findings, we propose to test this novel measure of exposure quality, EG, in a community setting including its reliability and validity, its pragmatism, and which community end-users can become reliable and valid reporters. Therapists at a large local CMHA (N = 40) treating anxious youth and young adults ages 5-25 (N = 300) will participate in this study. The EG will be completed by 1) agency supervisors monthly, 2) therapists per session, 3) patient/families per session, and 4) study raters per session. Results from this study will establish an innovative model for measuring therapeutic elements that trigger mechanism of change in real-world therapy as well as inform future use of EG as a training tool to improve exposure quality in community settings.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: December 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Concurrent psychotherapy for treatment of anxiety

• Psychosis, Pervasive Developmental Disorder, or Mental Retardation

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder in Children

Intervention

Behavioral:
• Exposure Therapy
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.

Locations

Country	Name	City	State
United States	Emma Pendleton Bradley Hospital	Riverside	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Bradley Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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