PTSDNCT03591107
Trauma-informed Collaborative Care for Low-income African Americans With PTSD
A study testing PTSD Care Management (PCM) in people with PTSD, run by RAND at 1 site in United States.
Trial summary
The purpose of this study is to optimize, culturally adapt, implement, and pilot test a trauma-informed collaborative care intervention for low-income African Americans who receive care in Federally Qualified Health Centers (FQHCs) in New Orleans, Louisiana. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- PTSD Care Management (PCM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a scheduled or walk-in appointment with a primary care provider at the clinic
- Age 18 or over
- Self-identify as African American
- Consider clinic their usual source of care
- No physical or cognitive disabilities that would preclude completing assessments
Who cannot join
- Does not screen positive for probable PTSD on the PCL-5
Trial locations and contacts
1 site in 1 country.
United States1 site
EXCELth Family Health and Dental 70127New Orleans East
New Orleans, Louisiana, 70127
About this study
Official title: Trauma-informed Collaborative Care for Low-income African Americans With Posttraumatic Stress Disorder (PTSD)
The purpose of this study is to optimize, culturally adapt, implement, and pilot test a trauma-informed collaborative care intervention for low-income African Americans who receive care in Federally Qualified Health Centers (FQHCs) in New Orleans, Louisiana. We will randomize 40 patients to either a Posttraumatic Stress Disorder (PTSD) collaborative care intervention or to an enhanced usual care control and will evaluate the effectiveness of the intervention (including whether outcome expectancy, coping efficacy, and trust mediate the impact of the intervention) as well as its feasibility, tolerability, and acceptability.
Read the detailed description
Posttraumatic stress disorder (PTSD) is prevalent in the general population, especially among low-income African Americans. Within primary care settings, PTSD may affect as many as one in four patients. PTSD is among the most difficult and costly psychiatric disorders to treat because it is necessary to go beyond traditional medical care to also address the trauma in patients' lives that interferes with treatment and potentially attenuates treatment benefits. African Americans are also less likely to receive care for mental health problems. Several social psychological barriers (e,g., mistrust in healthcare providers, skepticism about treatment efficacy, negative beliefs in one's ability to cope with PTSD), and logistical barriers (e.g., limited access to care, lack of transportation and childcare, lack of financial resources) impede engagement into care. Thus, a trauma-informed approach to care that emphasizes the promotion of trust, safety, self-efficacy, peer support, cultural competency, collaboration, and coordinates with social services in the community to address logistical barriers is required to treat PTSD in low-income African Americans.
Growing evidence suggests that collaborative care for PTSD in primary care is effective. In two studies (Telemedicine-Based Collaborative Care for PTSD (TOP) and Stepped Enhancement of PTSD Services Using Primary CARE (STEPS-UP)) collaborative care significantly improved outcomes relative to usual care and attributed success in large part to the high levels of patient engagement (100%) associated with strategies to connect patients to care including behavioral activation, problem solving, and motivational interviewing. Three trials showed overall improvements but no relative advantage for collaborative care over usual care. The Coordinated Anxiety Learning and Management (CALM) study of anxiety disorders among civilians showed a trend favoring collaborative care (the effect in the PTSD subgroup was not statistically significant due to the insufficient sample size) but engagement was high (95%). Another trial for veterans Re-Engineering Systems for the Primary Care Treatment of PTSD (RESPECT-PTSD) found no difference between arms. Our recently completed Violence and Stress Assessment (ViStA) trial for low-income patients in Federally Qualified Health Centers (FQHCs) also found no differential effect. In both ViStA and RESPECT-PTSD, patient engagement was low - only 73% and 62% of patients initiated treatment, respectively. However, in both studies, use of mental health services was significantly higher among the patients who engaged in collaborative care suggesting that adding strategies to boost engagement would increase its effectiveness. Also in ViStA, prior to the intervention, there were significant disparities in care for the African Americans in our sample with rates of minimally adequate care of only 21% compared to Whites (33%). This suggests that a trauma-informed approach that addresses social psychological and logistical barriers may better engage patients, enhance collaborative care, and ultimately, improve outcomes.
The Institute of Medicine has prioritized effective delivery approaches that engage individuals with PTSD. We propose to optimize, culturally adapt, and pilot test a collaborative care intervention that uses a trauma-informed approach to identify specific target mechanisms to improve treatment engagement, and reduce PTSD diagnosis and symptoms in primary care settings that serve low-income African Americans. Specifically, we will test the effectiveness of collaborative care, optimized based on lessons from previous studies, adapted to be culturally relevant for this population, and will directly address target mechanisms (outcome expectancy, coping efficacy, and trust). All components of collaborative care will be delivered by African American care managers (CMs) with the guidance of a local, African American community workgroup. We will compare this PTSD collaborative care with a CM (PCM) approach to minimally enhanced usual care (MEU). We submit this R34 application in response to RFA-MH-16-410, which elicits pilot effectiveness trials for treatment, preventive and services intervention. This proposal is an excellent fit for this funding opportunity because our intervention has potential to substantially impact practice and public health by improving mental health outcomes among African Americans with PTSD in New Orleans FQHCs using an empirically grounded approach. Our three Specific Aims are to:
Aim 1: Optimize, culturally adapt, and implement an evidence-based trauma-informed model of PTSD collaborative care (PCM) compared with MEU for underserved African Americans. We will recruit patients at two FQHCs in New Orleans, LA to assess the feasibility, tolerability, and acceptability of PCM.
Aim 2: Conduct a pilot randomized trial of the optimized/adapted PCM intervention compared with MEU in two FQHCs with 40 African American patients to evaluate its impact on social psychological target mechanisms - outcome expectancy, coping efficacy, and trust in facilitating treatment engagement.
Aim 3: Evaluate the effectiveness of the PCM intervention (compared with MEU) on outcomes - PTSD diagnosis and symptoms (primary outcomes) and use of mental health care and non-medical community services and resources (secondary outcomes) either directly or indirectly as mediated by the target mechanisms before and one year after the start of the intervention.
Preliminary data from this pilot effectiveness trial will pave the way for a larger-scale intervention.
- Conditions
- PTSD
- Being tested
- PTSD Care Management (PCM), Minimally Enhanced Usual Care (MEU)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSD Care Management (PCM)Other
Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
Minimally Enhanced Usual Care (MEU)Other
Education and feedback alone
| Study group | Role | What they receive |
|---|---|---|
| PTSD Care Management (PCM) | Experimental | In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist. Receives: Other: PTSD Care Management (PCM) |
| Minimally Enhanced Usual Care (MEU) | Active comparator | The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient. Receives: Other: Minimally Enhanced Usual Care (MEU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCL-5 Symptom Score
total count of 20 PTSD symptom ratings on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome
Measured: 0 months
Provisional PTSD Diagnosis
count/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)
Measured: 0 months
PCL-5 Symptom Score
total count of PTSD symptom scores on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome
Measured: approximately 9 months
Provisional PTSD Diagnosis
count/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)
Measured: approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start12 Oct 2018
- Primary completion2 Jul 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana Public Health Institute
- Responsible party
- Principal investigator, Lisa Meredith, RAND
- Investigators
- Lisa S Meredith, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591107
- Sponsor's protocol ID
- 1R34MH111860
- Status last verified
- Nov 2022
- First submitted
- 6 Jul 2018
- Last updated
- 2 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-informed Collaborative Care for Low-income African Americans With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT03591107
- Acronym / sponsor ID
- 1R34MH111860
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Louisiana Public Health Institute
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Posted 2 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to optimize, culturally adapt, implement, and pilot test a trauma-informed collaborative care intervention for low-income African Americans who receive care in Federally Qualified Health Centers (FQHCs) in New Orleans, Louisiana. We will randomize 40 patients to either a Posttraumatic Stress Disorder (PTSD) collaborative care intervention or to an enhanced usual care control and will evaluate the effectiveness of the intervention (including whether outcome expectancy, coping efficacy, and trust mediate the impact of the intervention) as well as its feasibility, tolerability, and acceptability.
Detailed description
Posttraumatic stress disorder (PTSD) is prevalent in the general population, especially among low-income African Americans. Within primary care settings, PTSD may affect as many as one in four patients. PTSD is among the most difficult and costly psychiatric disorders to treat because it is necessary to go beyond traditional medical care to also address the trauma in patients' lives that interferes with treatment and potentially attenuates treatment benefits. African Americans are also less likely to receive care for mental health problems. Several social psychological barriers (e,g., mistrust in healthcare providers, skepticism about treatment efficacy, negative beliefs in one's ability to cope with PTSD), and logistical barriers (e.g., limited access to care, lack of transportation and childcare, lack of financial resources) impede engagement into care. Thus, a trauma-informed approach to care that emphasizes the promotion of trust, safety, self-efficacy, peer support, cultural competency, collaboration, and coordinates with social services in the community to address logistical barriers is required to treat PTSD in low-income African Americans.
Growing evidence suggests that collaborative care for PTSD in primary care is effective. In two studies (Telemedicine-Based Collaborative Care for PTSD (TOP) and Stepped Enhancement of PTSD Services Using Primary CARE (STEPS-UP)) collaborative care significantly improved outcomes relative to usual care and attributed success in large part to the high levels of patient engagement (100%) associated with strategies to connect patients to care including behavioral activation, problem solving, and motivational interviewing. Three trials showed overall improvements but no relative advantage for collaborative care over usual care. The Coordinated Anxiety Learning and Management (CALM) study of anxiety disorders among civilians showed a trend favoring collaborative care (the effect in the PTSD subgroup was not statistically significant due to the insufficient sample size) but engagement was high (95%). Another trial for veterans Re-Engineering Systems for the Primary Care Treatment of PTSD (RESPECT-PTSD) found no difference between arms. Our recently completed Violence and Stress Assessment (ViStA) trial for low-income patients in Federally Qualified Health Centers (FQHCs) also found no differential effect. In both ViStA and RESPECT-PTSD, patient engagement was low - only 73% and 62% of patients initiated treatment, respectively. However, in both studies, use of mental health services was significantly higher among the patients who engaged in collaborative care suggesting that adding strategies to boost engagement would increase its effectiveness. Also in ViStA, prior to the intervention, there were significant disparities in care for the African Americans in our sample with rates of minimally adequate care of only 21% compared to Whites (33%). This suggests that a trauma-informed approach that addresses social psychological and logistical barriers may better engage patients, enhance collaborative care, and ultimately, improve outcomes.
The Institute of Medicine has prioritized effective delivery approaches that engage individuals with PTSD. We propose to optimize, culturally adapt, and pilot test a collaborative care intervention that uses a trauma-informed approach to identify specific target mechanisms to improve treatment engagement, and reduce PTSD diagnosis and symptoms in primary care settings that serve low-income African Americans. Specifically, we will test the effectiveness of collaborative care, optimized based on lessons from previous studies, adapted to be culturally relevant for this population, and will directly address target mechanisms (outcome expectancy, coping efficacy, and trust). All components of collaborative care will be delivered by African American care managers (CMs) with the guidance of a local, African American community workgroup. We will compare this PTSD collaborative care with a CM (PCM) approach to minimally enhanced usual care (MEU). We submit this R34 application in response to RFA-MH-16-410, which elicits pilot effectiveness trials for treatment, preventive and services intervention. This proposal is an excellent fit for this funding opportunity because our intervention has potential to substantially impact practice and public health by improving mental health outcomes among African Americans with PTSD in New Orleans FQHCs using an empirically grounded approach. Our three Specific Aims are to:
Aim 1: Optimize, culturally adapt, and implement an evidence-based trauma-informed model of PTSD collaborative care (PCM) compared with MEU for underserved African Americans. We will recruit patients at two FQHCs in New Orleans, LA to assess the feasibility, tolerability, and acceptability of PCM.
Aim 2: Conduct a pilot randomized trial of the optimized/adapted PCM intervention compared with MEU in two FQHCs with 40 African American patients to evaluate its impact on social psychological target mechanisms - outcome expectancy, coping efficacy, and trust in facilitating treatment engagement.
Aim 3: Evaluate the effectiveness of the PCM intervention (compared with MEU) on outcomes - PTSD diagnosis and symptoms (primary outcomes) and use of mental health care and non-medical community services and resources (secondary outcomes) either directly or indirectly as mediated by the target mechanisms before and one year after the start of the intervention.
Preliminary data from this pilot effectiveness trial will pave the way for a larger-scale intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD Care Management (PCM) | Experimental | Other: PTSD Care Management (PCM)In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist. |
| Minimally Enhanced Usual Care (MEU) | Active comparator | Other: Minimally Enhanced Usual Care (MEU)The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a scheduled or walk-in appointment with a primary care provider at the clinic
- Age 18 or over
- Self-identify as African American
- Consider clinic their usual source of care
- No physical or cognitive disabilities that would preclude completing assessments
Key exclusion criteria (1 listed)
- Does not screen positive for probable PTSD on the PCL-5
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 |
|---|---|---|
| PTSD Care Management (PCM)Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback | Other | PTSD Care Management (PCM) |
| Minimally Enhanced Usual Care (MEU)Education and feedback alone | Other | Minimally Enhanced Usual Care (MEU) |
Primary outcome
PCL-5 Symptom Score
Time frame: 0 months
total count of 20 PTSD symptom ratings on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome
Provisional PTSD Diagnosis
Time frame: 0 months
count/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)
PCL-5 Symptom Score
Time frame: approximately 9 months
total count of PTSD symptom scores on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome
Provisional PTSD Diagnosis
Time frame: approximately 9 months
count/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Lisa S Meredith, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD Care Management (PCM) in people with PTSD, run by RAND 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 5 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 2 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PCL-5 Symptom Score (time frame: 0 months). The study lists 4 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 2 Dec 2022.