Stress Disorders, TraumaticNCT06296030
Culturally Tailored ACT for Black Trauma
A study testing POOF ACT program and Classic ACT program in people with Stress Disorders, Traumatic and Anxiety, run by Azusa Pacific University at 1 site in United States.
Trial summary
Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Traumatic, Anxiety, Anxiety Disorders
- What is being tested?
- POOF ACT program and Classic ACT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Aug 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing/ desiring to commit to engagement in a 12-week tele-health anxiety group
- self-identifies as African American or of Black American heritage
- age 18 years or over
- age 65 years or younger
- English-speaking, writing, and understanding
- able to provide informed consent
- is experiencing mild or moderate anxiety or stress-related symptoms, based on pre-screening testing
- has experience with video-based social media, Zoom, or other synchronous video-based modalities
Who cannot join
- At the screening, those who state they have additional psychological, behavioral, or medical disorders (outside of anxiety, stress, or trauma-related disorders) as their primary concern. For instance, if a participant was diagnosed with major depressive disorder as primary and an anxiety disorder as secondary, they would be excluded from the study.
- At the screening, those who are experiencing anxiety due to a physical condition (due to a cancer diagnosis or some other physical diagnosis) would be excluded from this study.
- Individuals who are experiencing extreme psychological symptoms are not appropriate for a tele-health group format.
- Persons who are on medication for any psychological disorder at the time of screening may not be appropriate for this tele-health group format.
- Those who have not been introduced to web-based formats of live interaction prior to the study (if they have no experience with technology or they are not comfortable with technology) would not be appropriate for this particular tele-health pilot study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: POOF: A Culturally Tailored Intervention for African American Trauma Based on Acceptance and Commitment Therapy
Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.
Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:
Read more
Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.
Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.
The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact.
- Conditions
- Stress Disorders, Traumatic, Anxiety, Anxiety Disorders
- Being tested
- POOF ACT program, Classic ACT program
- Medical subject headings
- Stress Disorders, Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POOF ACT programBehavioural
Also called POOF, Pulling Out Of Fire
The goal of this study is to test this culturally tailored intervention (POOF) against classic ACT, to discover if POOF does better at decreasing race-based trauma in African Americans.Guided by the cultural humility framework and social determinants of health model, we examine POOF, a culturally-tailored ACT model for use with anxious African Americans. The POOF approach builds on research on ACT for the general population, an evidence-based intervention, by tailoring the language of ACT while retaining the fidelity of the ACT model. Our hypotheses examine acceptability and attitudes toward treatment, treatment outcomes for psychological symptoms (i.e., anxiety) and an ACT-related outcome (i.e., psychological flexibility), and a possible underlying mechanism of change (i.e., race-based stress).
Classic ACT programBehavioural
Also called Classic ACT, Traditional ACT
This protocol is for a classic, non-adapted ACT intervention.
| Study group | Role | What they receive |
|---|---|---|
| Classic ACT program | Experimental | Participants will engage in pre-test measures (anxiety, race-based stress, and psychological flexibility). Subjects will then participate in a 12-week telehealth group (once a week, 2 hours a week) with other group members where a classic Acceptance and Commitment Therapy protocol will be administered. After this, participants will engage in post-test measures. Receives: Behavioral: Classic ACT program |
| POOF ACT program | Experimental | Participants will engage in pre-test measures (anxiety, race-based stress, and psychological flexibility). Subjects will then participate in a 12-week telehealth group (once a week, 2 hours a week) with other group members where an Acceptance and Commitment Therapy protocol will be administered that has been culturally tailored to address African American racial trauma. After this, participants will engage in post-test measures. Receives: Behavioral: POOF ACT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Race-Based Traumatic Stress
The Race-Based Traumatic Stress Symptom Scale (RBTSSS)
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Why it stopped: Original PI, Dr. Jennifer Payne Shepard, transferred to another university. Study was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, TraumaticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This project's research design is a two-by-two factorial design. Factor one, the type of ACT intervention delivered, has two levels - POOF delivery (level 1) and a classic ACT delivery (level 2). Factor two, the facilitator's first group treatment delivery, also has two levels. There are four (4) group facilitators. The first two facilitators deliver traditional ACT first (level 1), and the second two facilitators deliver POOF first (level 2). Each facilitator providing group treatment will facilitate two groups (classic and POOF), one after the next. However, facilitators will be randomized to the order in which they deliver their first group to reduce experimenter/ clinician history bias. All of the facilitators are licensed, mental health clinicians.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azusa Pacific University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer S Payne, Ph.D., Principal investigator, Azusa Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296030
- Sponsor's protocol ID
- 22-0010
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POOF: A Culturally Tailored Intervention for African American Trauma Based on Acceptance and Commitment Therapy
- ClinicalTrials.gov ID
- NCT06296030
- Acronym / sponsor ID
- 22-0010
- Conditions
- Stress Disorders, Traumatic, Anxiety, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Original PI, Dr. Jennifer Payne Shepard, transferred to another university. Study was discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azusa Pacific UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 6 Mar 2024 (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.
Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.
Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:
Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.
Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.
The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This project's research design is a two-by-two factorial design. Factor one, the type of ACT intervention delivered, has two levels - POOF delivery (level 1) and a classic ACT delivery (level 2). Factor two, the facilitator's first group treatment delivery, also has two levels. There are four (4) group facilitators. The first two facilitators deliver traditional ACT first (level 1), and the second two facilitators deliver POOF first (level 2). Each facilitator providing group treatment will facilitate two groups (classic and POOF), one after the next. However, facilitators will be randomized to the order in which they deliver their first group to reduce experimenter/ clinician history bias. All of the facilitators are licensed, mental health clinicians.
| Arm | Type | Receives |
|---|---|---|
| Classic ACT program | Experimental | Behavioral: Classic ACT programParticipants will engage in pre-test measures (anxiety, race-based stress, and psychological flexibility). Subjects will then participate in a 12-week telehealth group (once a week, 2 hours a week) with other group members where a classic Acceptance and Commitment Therapy protocol will be administered. After this, participants will engage in post-test measures. |
| POOF ACT program | Experimental | Behavioral: POOF ACT programParticipants will engage in pre-test measures (anxiety, race-based stress, and psychological flexibility). Subjects will then participate in a 12-week telehealth group (once a week, 2 hours a week) with other group members where an Acceptance and Commitment Therapy protocol will be administered that has been culturally tailored to address African American racial trauma. After this, participants will engage in post-test measures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- willing/ desiring to commit to engagement in a 12-week tele-health anxiety group
- self-identifies as African American or of Black American heritage
- age 18 years or over
- age 65 years or younger
- English-speaking, writing, and understanding
Key exclusion criteria (5 listed)
- At the screening, those who state they have additional psychological, behavioral, or medical disorders (outside of anxiety, stress, or trauma-related disorders) as their primary concern. For instance, if a participant was diagnosed with major depressive disorder as primary and an anxiety disorder as secondary, they would be excluded from the study.
- At the screening, those who are experiencing anxiety due to a physical condition (due to a cancer diagnosis or some other physical diagnosis) would be excluded from this study.
- Individuals who are experiencing extreme psychological symptoms are not appropriate for a tele-health group format.
- Persons who are on medication for any psychological disorder at the time of screening may not be appropriate for this tele-health group format.
- Those who have not been introduced to web-based formats of live interaction prior to the study (if they have no experience with technology or they are not comfortable with technology) would not be appropriate for this particular tele-health pilot study.
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 |
|---|---|---|
| POOF ACT programAlso: POOF, Pulling Out Of FireThe goal of this study is to test this culturally tailored intervention (POOF) against classic ACT, to discover if POOF does better at decreasing race-based trauma in African Americans.Guided by the cultural humility framework and social determinants of health model, we examine POOF, a culturally-tailored ACT model for use with anxious African Americans. The POOF approach builds on research on ACT for the general population, an evidence-based intervention, by tailoring the language of ACT while retaining the fidelity of the ACT model. Our hypotheses examine acceptability and attitudes toward treatment, treatment outcomes for psychological symptoms (i.e., anxiety) and an ACT-related outcome (i.e., psychological flexibility), and a possible underlying mechanism of change (i.e., race-based stress). | Behavioural | POOF ACT program |
| Classic ACT programAlso: Classic ACT, Traditional ACTThis protocol is for a classic, non-adapted ACT intervention. | Behavioural | Classic ACT program |
Primary outcome
Race-Based Traumatic Stress
Time frame: 12-weeks
The Race-Based Traumatic Stress Symptom Scale (RBTSSS)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Jennifer S Payne, Ph.D. principal investigator
Azusa Pacific University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POOF ACT program and Classic ACT program in people with Stress Disorders, Traumatic and Anxiety, run by Azusa Pacific 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 8 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Mar 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Race-Based Traumatic Stress (time frame: 12-weeks). 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 6 Mar 2024.