Anxiety DisordersSTRIVENCT04035057
Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy
A study testing Behaviorally Enhanced Training and Standard Didactic Training in people with Anxiety Disorders, run by Bradley Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Behaviorally Enhanced Training and Standard Didactic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agency hours >8 hours a week.
- 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
Who cannot join
- Training procedure are unacceptable to therapist
- Patient Participants: Age 5 - 17 years
- Concurrent psychotherapy for treatment of anxiety
- Psychosis, Pervasive Developmental Disorder, or Mental Retardation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bradley Hospital
Riverside, Rhode Island, 02915
Joshua Kemp, PhD, 401-432-1466, joshua.kemp@lifespan.org
Joshua Kemp, PhD
About this study
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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- Behaviorally Enhanced Training, Standard Didactic Training
- Keywords
- Therapist Training, Exposure Therapy, Experimental Therapeutics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviorally Enhanced TrainingOther
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.
Standard Didactic TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Didactic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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).
Measured: Independent raters will administer the CY-BOCS at pre-treatment and post-treatment, on average 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Kemp, Bradley Hospital
- Investigators
- Joshua Kemp, PhD, Principal investigator, Bradley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035057
- Sponsor's protocol ID
- R34MH118199
- Acronym
- STRIVE
- Status last verified
- Jul 2019
- First submitted
- 29 Apr 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures, but not raw coding data, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Behavioral Strategies for Enhancing Therapists' Delivery of Exposure Therapy
- ClinicalTrials.gov ID
- NCT04035057
- Acronym / sponsor ID
- STRIVE / R34MH118199
- Conditions
- Anxiety Disorders
- Keywords
- Therapist Training, Exposure Therapy, Experimental Therapeutics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behaviorally Enhanced Training Strategies | Experimental | Other: Behaviorally Enhanced TrainingBoth 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. |
| Standard Didactic Training | Active comparator | Other: Standard Didactic TrainingBoth 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agency hours >8 hours a week.
- 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
Key exclusion criteria (4 listed)
- Training procedure are unacceptable to therapist
- Patient Participants: Age 5 - 17 years
- Concurrent psychotherapy for treatment of anxiety
- Psychosis, Pervasive Developmental Disorder, or Mental Retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviorally Enhanced TrainingTherapists 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. | Other | Behaviorally Enhanced Training Strategies |
| Standard Didactic TrainingTherapists 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. | Other | Standard Didactic Training |
Primary outcome
Change in therapist reservations about exposure
Time frame: Baseline (pre-workshop) & End of the 1.5 day Training Workshop
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
Time frame: End of 1.5 day Training Workshop & End of Therapist Participation in the Study, on average 1 year.
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
Time frame: The first 12 exposure sessions with patients recruited to the study will be videotaped and coded, on average 3 months.
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.
2 secondary outcomes
Change in Patients' Symptoms of Anxiety
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)
Time frame: Independent raters will administer the CY-BOCS at pre-treatment and post-treatment, on average 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures, but not raw coding data, will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Kemp, PhD principal investigator
Bradley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviorally Enhanced Training and Standard Didactic Training in people with Anxiety Disorders, run by Bradley Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Kemp, PhD (401-432-1466, joshua.kemp@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in therapist reservations about exposure (time frame: Baseline (pre-workshop) & End of the 1.5 day Training Workshop). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.