Clinical trial NCT04035057: Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy
Official title: Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: Therapist Training
Exposure Therapy
Experimental Therapeutics
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in therapist reservations about exposure
timeFrame: Baseline (pre-workshop) & End of the 1.5 day Training Workshop
measure: Change in therapist reservations about exposure
timeFrame: End of 1.5 day Training Workshop & End of Therapist Participation in the Study, on average 1 year.
measure: Therapist Delivery Behavior
timeFrame: The first 12 exposure sessions with patients recruited to the study will be videotaped and coded, on average 3 months.
Secondary outcomes:
measure: Change in Patients' Symptoms of Anxiety
timeFrame: Independent raters will administer the PARS at pre-treatment and post-treatment, on average 3 months
measure: Change in Patients' Symptoms of Obsessive-Compulsive Disorder (OCD)
timeFrame: Independent raters will administer the CY-BOCS at pre-treatment and post-treatment, on average 3 months.
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
affiliation: Bradley Hospital
name: Joshua Kemp, PhD
role: PRINCIPAL_INVESTIGATOR
References: