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Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy (STRIVE)

Primary Purpose

Anxiety Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behaviorally Enhanced Training
Standard Didactic Training
Sponsored by
Bradley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety Disorders focused on measuring Therapist Training, Exposure Therapy, Experimental Therapeutics

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Therapists

  • Agency hours >8 hours a week.

Exclusion Criteria:

  • Training procedure are unacceptable to therapist

Patient Participants: Age 5 - 17 years

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Bradley HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behaviorally Enhanced Training Strategies

Standard Didactic Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change in Patients' Symptoms of Anxiety
Patients with symptoms of anxiety will be administered the Pediatric Anxiety Rating Scale (PARS), which is a clinician-rated measure of anxiety symptom severity for use with multiple anxiety disorders. The measure consists of a symptom checklist and seven symptom severity items. The symptom severity items are rated using a 0 to 5 scale with lower ratings indicating less severity. Scores are summed and range from 0 to 35.
Change in Patients' Symptoms of Obsessive-Compulsive Disorder (OCD)
Patients presenting with symptoms of OCD will be administered the Child Yale-Brown Obsessive-Compulsive Scales (CY-BOCS)61: the clinician-administered, "gold standard" assessment of OCD symptom severity with excellent psychometric properties. Total scores for obsession and compulsion subscales range from 0 (no symptoms) to 40 (severe).

Full Information

First Posted
April 29, 2019
Last Updated
July 24, 2019
Sponsor
Bradley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04035057
Brief Title
Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy
Acronym
STRIVE
Official Title
Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bradley Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Following decades of psychosocial treatment research the field has established numerous evidence-based practices (EBPs) for mental disorders, but has struggled to widely disseminate these practices in community settings. Exposure therapy for anxiety disorders represents one of the most glaring examples of this research to practice gap. A well-known barrier to the dissemination and quality delivery of exposure therapy is therapists' negative beliefs about its potential danger or intolerability for patients. These beliefs are common even among therapists who report receiving specialized training; thus, research is needed to develop targeted training strategies for reducing negative beliefs and improving delivery quality. Preliminary research suggests specific behavioral strategies (i.e., self-exposure) may reduce negative beliefs above and beyond standard didactic trainings (Farrell, Kemp et al., 2016). Building upon these findings, the investigators propose a novel experimental therapeutics approach to developing and testing a targeted behavioral training for augmenting negative beliefs in a sample of community mental health professionals. The first phase of the study is a case-series analysis for establishing target engagement (i.e., belief reduction) and determining adequate dosing of the behavioral strategies. Phase two is a randomized trial of the behaviorally-enhanced training strategies (BeTS) against a standard didactic protocol. Therapist will complete a day-long workshop followed by weekly consultation while delivering exposure for children with anxiety disorders. In-session delivery behavior will be recorded and examined using a validated micro-analytic coding system. It is hypothesized that therapists in the BeTS condition will evidence significantly lower negative beliefs about exposure relative to the didactic condition, at 1) post-workshop, and 2) end of study. IT is also hypothesized that the degree of negative belief reduction following the initial workshop training will be associated with 1) higher rates of optimal in-session delivery behaviors, and 2) lower rates of suboptimal delivery behaviors as measured by both self-report and observational coding data. This study will establish an innovative model for developing a targeted training intervention capable of increasing the dissemination and quality of exposure therapy and other EBPs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Therapist Training, Exposure Therapy, Experimental Therapeutics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Therapist participants who are completing the training intervention are blind to the other training condition
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behaviorally Enhanced Training Strategies
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Didactic Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Behaviorally Enhanced Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Didactic Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in therapist reservations about exposure
Description
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.
Time Frame
Baseline (pre-workshop) & End of the 1.5 day Training Workshop
Title
Change in therapist reservations about exposure
Description
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.
Time Frame
End of 1.5 day Training Workshop & End of Therapist Participation in the Study, on average 1 year.
Title
Therapist Delivery Behavior
Description
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.
Time Frame
The first 12 exposure sessions with patients recruited to the study will be videotaped and coded, on average 3 months.
Secondary Outcome Measure Information:
Title
Change in Patients' Symptoms of Anxiety
Description
Patients with symptoms of anxiety will be administered the Pediatric Anxiety Rating Scale (PARS), which is a clinician-rated measure of anxiety symptom severity for use with multiple anxiety disorders. The measure consists of a symptom checklist and seven symptom severity items. The symptom severity items are rated using a 0 to 5 scale with lower ratings indicating less severity. Scores are summed and range from 0 to 35.
Time Frame
Independent raters will administer the PARS at pre-treatment and post-treatment, on average 3 months
Title
Change in Patients' Symptoms of Obsessive-Compulsive Disorder (OCD)
Description
Patients presenting with symptoms of OCD will be administered the Child Yale-Brown Obsessive-Compulsive Scales (CY-BOCS)61: the clinician-administered, "gold standard" assessment of OCD symptom severity with excellent psychometric properties. Total scores for obsession and compulsion subscales range from 0 (no symptoms) to 40 (severe).
Time Frame
Independent raters will administer the CY-BOCS at pre-treatment and post-treatment, on average 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Therapists Agency hours >8 hours a week. Exclusion Criteria: Training procedure are unacceptable to therapist Patient Participants: Age 5 - 17 years Inclusion Criteria: 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 Exclusion Criteria: Concurrent psychotherapy for treatment of anxiety Psychosis, Pervasive Developmental Disorder, or Mental Retardation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Kemp, PhD
Phone
401-432-1466
Email
joshua.kemp@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Edwards, B.S.
Phone
401-432-1468
Email
ledwards@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Kemp, PhD
Organizational Affiliation
Bradley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bradley Hospital
City
Riverside
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Kemp, PhD
Phone
401-432-1466
Email
joshua.kemp@lifespan.org
First Name & Middle Initial & Last Name & Degree
Joshua Kemp, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures, but not raw coding data, will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

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Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy

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