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Quality Assessment in Exposure Therapy

B

Bradley Hospital

Status

Active, not recruiting

Conditions

Obsessive-Compulsive Disorder in Children

Treatments

Behavioral: Exposure Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03182101
1039342

Details and patient eligibility

About

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.

Full 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.

Enrollment

177 patients

Sex

All

Ages

5 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

177 participants in 1 patient group

Exposure Therapy with fidelity checklist
Experimental group
Description:
Therapist and parent/child participants will complete an Exposure Guide after each session.
Treatment:
Behavioral: Exposure Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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