An interventional study of Behaviorally Enhanced Training and Standard Didactic Training in Anxiety Disorders, sponsored by Bradley Hospital. Status unknown at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Bradley Hospital · Not applicable, Interventional, and Other
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 32 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Bradley Hospital is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
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Inclusion Criteria: Therapists
Exclusion Criteria:
Patient Participants: Age 5 - 17 years
Inclusion Criteria:
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: The first 12 exposure sessions with patients recruited to the study will be videotaped and coded, on average 3 months.
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.
Time frame: 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)
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.
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures, but not raw coding data, will be made available.
Supporting information: Study protocol
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