Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy

NCT04035057 | Unknown DMC

• 1 other identifier: R34MH118199
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test a targeted training for overcoming known barriers to the uptake and quality delivery of exposure therapy among community mental health providers. The first phase (Year 1) of the study is a case-series analysis of six therapists with the goal of determining whether the targeted training strategies (i.e., exposure to exposure) are capable of engaging therapists' reservations about exposure. Information from the first phase will be used to optimize the behavioral training strategies to be tested in the second phase. The second phase (Years 2 \& 3) will be a randomized trial of training conditions comparing Behaviorally Enhanced Training Strategies to a Standard Didactic Training. After an initial workshop training, therapists in the second phase will receive ongoing consultation while they deliver exposure therapy with their anxious patients. Sessions will be video-recorded and therapist behaviors will be coded to assess for differences in the manner in which exposure is delivered between training conditions.

Conditions

Anxiety Disorders

Keywords

Therapist Training; Exposure Therapy; Experimental Therapeutics

Outcome Measures

Primary Outcomes (3)

• Change in therapist reservations about exposure

  The Therapist Beliefs about Exposure (TBES) will be administered to assess the extent to which therapists harbor negative perceptions of exposure therapy and its tolerability among their patients. The TBES is a 21-item scale with a 0 ("Disagree Strongly") to 4 ("Strongly Agree") rating scale. TBES scores are summed and range from 0 to 84, with lower scores indicating less reservations.

  Baseline (pre-workshop) & End of the 1.5 day Training Workshop

• Change in therapist reservations about exposure

  The Therapist Beliefs about Exposure (TBES) will be administered to assess the extent to which therapists harbor negative perceptions of exposure therapy and its tolerability among their patients. The TBES is a 21-item scale with a 0 ("Disagree Strongly") to 4 ("Strongly Agree") rating scale. TBES scores are summed and range from 0 to 84, with lower scores indicating less reservations.

  End of 1.5 day Training Workshop & End of Therapist Participation in the Study, on average 1 year.

• Therapist Delivery Behavior

  We will apply a validated microanalytic coding system to determine the extent to which therapists' in-session behavior aligns with indicators of "optimal" and "suboptimal" delivery. Videotaped delivery behaviors are coded and time-stamped. Categories of delivery behavior are then summed within and across sessions.

  The first 12 exposure sessions with patients recruited to the study will be videotaped and coded, on average 3 months.

Secondary Outcomes (2)

• Change in Patients' Symptoms of Anxiety

  Independent raters will administer the PARS at pre-treatment and post-treatment, on average 3 months

• Change in Patients' Symptoms of Obsessive-Compulsive Disorder (OCD)

  Independent raters will administer the CY-BOCS at pre-treatment and post-treatment, on average 3 months.

Study Arms (2)

Behaviorally Enhanced Training Strategies

EXPERIMENTAL

Both training conditions will receive a 1.5 day training followed by ongoing supervision while they implement exposure therapy with patients recruited to the study. The first full day will consist of the same foundational information in both conditions. The two conditions will differ in their training focus during the subsequent half-day training. The Behaviorally Enhanced condition will involve therapist engagement in repeated self-exposure and partner-exposure exercises with the goal of targeting and reducing therapists' reservations about using exposure with their patients. The focus of ongoing supervision following the initial 1.5 day training workshop will also differ by condition. The Behaviorally Enhanced condition will include regular sampling and feedback on therapists' remaining reservations about exposure in additional to counseling the implementation of exposure with therapists' patients.

Other: Behaviorally Enhanced Training

Standard Didactic Training

ACTIVE COMPARATOR

Both training conditions will receive a 1.5 day training followed by ongoing supervision while they implement exposure therapy with patients recruited to the study. The first full day will consist of the same foundational information in both conditions.The two conditions will differ in their training focus during the subsequent half-day training. The Standard Didactic condition will involve additional didactic instruction related to common barriers and more advanced delivery concepts than will be presented in the half-day training for the Behaviorally Enhanced condition. The focus of ongoing supervision following the initial 1.5 day training workshop will also differ by condition. The Standard Didactic condition will involve counseling on the implementation of exposure with therapists' patients without explicit focus on therapists' remaining reservations about exposure.

Other: Standard Didactic Training

Interventions

Behaviorally Enhanced Training OTHER

Therapists in the Behaviorally Enhanced Training will receive the same didactic instruction as those in the Standard Didactic Training arm during the first full day of training. In the second half-day training, those in the Behaviorally Enhanced Training arm will focus on behavioral strategies (i.e., exposure to exposure) that provide direct experience with the process of treatment delivery.

Behaviorally Enhanced Training Strategies

Standard Didactic Training OTHER

Therapists in the Standard Didactic Training arm will complete training as usual, consisting of PowerPoint and video training tasks instructing the delivery of exposure therapy for anxious youth.

Standard Didactic Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agency hours \>8 hours a week.

You may not qualify if:

• Training procedure are unacceptable to therapist
• Patient Participants: Age 5 - 17 years
• Primary or co-primary diagnosis of Separation Anxiety Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, or OCD
• Children \< age 12 have a caretaker available to participate in treatment
• Patient and at least one parent are English speaking
• Concurrent psychotherapy for treatment of anxiety
• Psychosis, Pervasive Developmental Disorder, or Mental Retardation.

Sponsors & Collaborators

• Bradley Hospital: lead

Study Sites (1)

Bradley Hospital

Riverside, Rhode Island, 02915, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Joshua Kemp, PhD

  Bradley Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Kemp, PhD

CONTACT

401-432-1466; joshua.kemp@lifespan.org

Lauren Edwards, B.S.

CONTACT

401-432-1468; ledwards@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Therapist participants who are completing the training intervention are blind to the other training condition
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two phases: Phase I is a case-series analysis to determine the necessary dosage to engage the training intervention target (i.e., therapist negative beliefs). Phase II is a randomized trial of a behaviorally-enhanced training versus standard didactic training.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: July 29, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

US (1)