AnxietyNCT03354975
Experiential Training for Community Therapists
A study testing Experiential Training and Training-As-Usual in people with Anxiety, run by Temple University at 1 site in United States.
Trial summary
The primary goal of this study is to evaluate the feasibility and acceptability of employing an experiential training approach that targets community mental health therapists' attitudes toward and use of exposure therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Experiential Training and Training-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2018to 1 Nov 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be aged 21 and older with degrees (masters or doctorate) in a mental health field. They must be working in a community mental health clinic, currently treating at least one client with anxiety, and planning to continue providing therapy to at least one client with anxiety for the duration of the study. Participants must be interested in participating in a training workshop and able to commit to the time requirements for study completion. They must also be willing to provide an email or mailing address to complete study-related surveys. Finally, they must be able to read and speak English.
Who cannot join
- Participants cannot have previously attended a full day (8+ hours) workshop on exposure-based treatments for anxiety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dissemination of Exposure-Based Treatment for Anxiety: Experiential Training for Community Therapists
The primary goal of this study is to evaluate the feasibility and acceptability of employing an experiential training approach that targets community mental health therapists' attitudes toward and use of exposure therapy. In addition to assessing attitudes and use of exposure therapy, the study will evaluate the feasibility of recruitment, randomization, retention, and assessment processes, as well as the acceptability of the experiential training relative to training-as-usual. To assess these outcomes, community therapists will be randomized to experiential training or training-as-usual. A subset of therapists from each arm will also complete qualitative interviews to further assess acceptability of the training approaches. The training-as-usual condition will include a traditional one-day workshop that focuses on principles of exposure and incorporates active learning strategies. The experiential training will include a one-day workshop that teaches principles of exposure and has therapists themselves undergo a one-session phobia treatment for spiders. Therapists in both training conditions will be asked to attend weekly consultation phone calls for a three-month period following the trainings.
- Conditions
- Anxiety
- Being tested
- Experiential Training, Training-As-Usual
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiential TrainingBehavioural
Participants in the experiential training will be provided with information about using exposure therapy to treat patients with anxiety via lecture-style teaching. Then, they will themselves undergo a one-session phobia treatment for spiders.
Training-As-UsualBehavioural
The training-as-usual condition will incorporate passive and active learning components. The first half of the training will include lecture-style teaching about using exposure therapy to treat patients with anxiety. The second half of training will incorporate active learning components (e.g., role plays) to reinforce concepts discussed in the first half of training.
| Study group | Role | What they receive |
|---|---|---|
| Experiential Training | Experimental | Not described Receives: Behavioral: Experiential Training |
| Training-as-usual | Active comparator | Not described Receives: Behavioral: Training-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Therapist Beliefs about Exposure Scale (TBES) at 3-month follow-up
The Therapist Beliefs about Exposure Scale is a 21-item self-report measure that assesses therapists' negative beliefs about exposure therapy. Agreement with each item is rated on a 5-point scale ranging from 0 (disagree strongly) to 4 (agree strongly), yielding a total score ranging from 0 to 84. Higher scores indicate more negative beliefs about exposure.
Measured: Pre-training; 3-month follow-up
Change from baseline Exposure Therapy Clinical Use Survey (ETCUS) at 3-month follow-up
The ETCUS measures therapist-reported use of nine exposure therapy procedures, such as providing the rationale for exposure therapy, creating a hierarchy, and completing in-vivo exposures.
Measured: Pre-training; 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start23 Mar 2018
- Primary completion24 Jul 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354975
- Sponsor's protocol ID
- 260359
- Other IDs
- F31MH112211
- Status last verified
- Jan 2019
- First submitted
- 13 Nov 2017
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of Exposure-Based Treatment for Anxiety: Experiential Training for Community Therapists
- ClinicalTrials.gov ID
- NCT03354975
- Acronym / sponsor ID
- 260359
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 28 Nov 2017 (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 primary goal of this study is to evaluate the feasibility and acceptability of employing an experiential training approach that targets community mental health therapists' attitudes toward and use of exposure therapy. In addition to assessing attitudes and use of exposure therapy, the study will evaluate the feasibility of recruitment, randomization, retention, and assessment processes, as well as the acceptability of the experiential training relative to training-as-usual. To assess these outcomes, community therapists will be randomized to experiential training or training-as-usual. A subset of therapists from each arm will also complete qualitative interviews to further assess acceptability of the training approaches. The training-as-usual condition will include a traditional one-day workshop that focuses on principles of exposure and incorporates active learning strategies. The experiential training will include a one-day workshop that teaches principles of exposure and has therapists themselves undergo a one-session phobia treatment for spiders. Therapists in both training conditions will be asked to attend weekly consultation phone calls for a three-month period following the trainings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiential Training | Experimental | Behavioral: Experiential Training |
| Training-as-usual | Active comparator | Behavioral: Training-As-Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be aged 21 and older with degrees (masters or doctorate) in a mental health field. They must be working in a community mental health clinic, currently treating at least one client with anxiety, and planning to continue providing therapy to at least one client with anxiety for the duration of the study. Participants must be interested in participating in a training workshop and able to commit to the time requirements for study completion. They must also be willing to provide an email or mailing address to complete study-related surveys. Finally, they must be able to read and speak English.
Key exclusion criteria (1 listed)
- Participants cannot have previously attended a full day (8+ hours) workshop on exposure-based treatments for anxiety.
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 |
|---|---|---|
| Experiential TrainingParticipants in the experiential training will be provided with information about using exposure therapy to treat patients with anxiety via lecture-style teaching. Then, they will themselves undergo a one-session phobia treatment for spiders. | Behavioural | Experiential Training |
| Training-As-UsualThe training-as-usual condition will incorporate passive and active learning components. The first half of the training will include lecture-style teaching about using exposure therapy to treat patients with anxiety. The second half of training will incorporate active learning components (e.g., role plays) to reinforce concepts discussed in the first half of training. | Behavioural | Training-as-usual |
Primary outcome
Change from baseline Therapist Beliefs about Exposure Scale (TBES) at 3-month follow-up
Time frame: Pre-training; 3-month follow-up
The Therapist Beliefs about Exposure Scale is a 21-item self-report measure that assesses therapists' negative beliefs about exposure therapy. Agreement with each item is rated on a 5-point scale ranging from 0 (disagree strongly) to 4 (agree strongly), yielding a total score ranging from 0 to 84. Higher scores indicate more negative beliefs about exposure.
Change from baseline Exposure Therapy Clinical Use Survey (ETCUS) at 3-month follow-up
Time frame: Pre-training; 3-month follow-up
The ETCUS measures therapist-reported use of nine exposure therapy procedures, such as providing the rationale for exposure therapy, creating a hierarchy, and completing in-vivo exposures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiential Training and Training-As-Usual in people with Anxiety, run by Temple University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Therapist Beliefs about Exposure Scale (TBES) at 3-month follow-up (time frame: Pre-training; 3-month follow-up). The study lists 2 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 3 Jan 2019.