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CompletedNCT03591107Updated Dec 2, 2022Results posted

Trauma-informed Collaborative Care for Low-income African Americans With PTSD

An interventional study of PTSD Care Management (PCM) and Minimally Enhanced Usual Care (MEU) in PTSD, sponsored by RAND. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-02.

Sponsored by RAND · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • PTSD
03

In context

Lead sponsor

RAND is the lead sponsor of 110 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Does not screen positive for probable PTSD on the PCL-5
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    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.

    Other: PTSD Care Management (PCM)

  • Active comparator
    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.

    Other: Minimally Enhanced Usual Care (MEU)

Interventions

  • OtherPTSD 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

  • OtherMinimally Enhanced Usual Care (MEU)

    Education and feedback alone

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0 months

  2. 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)

    Time frame: 0 months

  3. 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

    Time frame: approximately 9 months

  4. 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)

    Time frame: approximately 9 months

07

Results

Posted Dec 2, 2022
Limitations and caveats
This pilot study was limited to a single clinic and may only generalize to settings that serve African Americans in New Orleans. The small sample size limits statistical conclusion validity, but patients were randomized to each arm so that internal validity was retained.

Participant flow

We completed patient recruitment across 70 days over the course of nine months from October 12, 2018, to July 2, 2019. Patients were approached in the primary care waiting area and if they met inclusion criteria they were asked to complete a brief PTSD symptom checklist, followed by a longer PTSD assessment. If patients met criteria for a provisional diagnosis of PTSD, they were invited to enroll in the study and asked for informed consent (n= 42) adult patients.

Participant flow — Overall Study
MilestonePTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)
Started2121
Completed2016
Not completed15
Withdrew: Same patient in both arms11
Withdrew: Sought care at other clinics02
Withdrew: Discharged from clinic01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryPCL-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

Time frame:
0 months
Reported as:
Mean · score on a scale
PCL-5 Symptom Score
score on a scalePTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)
PCL-5 Symptom Score73.32 ± 13.772.95 ± 14.3
PrimaryProvisional 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)

Time frame:
0 months
Reported as:
Count of participants · Participants
Provisional PTSD Diagnosis
ParticipantsPTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)
Provisional PTSD Diagnosis1921
PrimaryPCL-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

Time frame:
approximately 9 months
Reported as:
Mean · score on a scale
PCL-5 Symptom Score
score on a scalePTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)
PCL-5 Symptom Score37.07 ± 17.847.27 ± 15.5
PrimaryProvisional 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)

Time frame:
approximately 9 months
Reported as:
Count of participants · Participants
Provisional PTSD Diagnosis
ParticipantsPTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)
Provisional PTSD Diagnosis814

Adverse events

Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PTSD Care Management (PCM)0/19 (0%)3/19 (15.8%)1/19 (5.3%)
Minimally Enhanced Usual Care (MEU)0/21 (0%)5/21 (23.8%)0/21 (0%)
Most frequent serious events
Most frequent serious events
EventPTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)
Severe or significant emotional or psychological distressPsychiatric disorders3/195/21
Most frequent other events
Most frequent other events
EventPTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)
Release of PIIInvestigations1/190/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
<=18 years000
Between 18 and 65 years192140
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
Female161632
Male358
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
African American192140
Education
Education(Participants)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
< High school21012
High school graduate/GED8917
College degree or graduate9211
Marital status
Marital status(Participants)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
Single131023
Married or unmarried couple134
Separated/divorced/widowed5813
Type of medical insurance
Type of medical insurance(Participants)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
Medicaid151833
Medicare213
Employer/private112
Other (Medicaid and Medicare)011
No insurance101
Born in the United States
Born in the United States(Participants)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
Count of participants182139
Years lived in the United States
Years lived in the United States(Years)PTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
Mean39.84 ± 11.645.38 ± 12.542.75 ± 12.3

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • EXCELth Family Health and Dental 70127New Orleans East
    New Orleans, Louisiana 70127, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 15, 2017
  • Informed consent form · Sep 5, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03591107
Lead sponsor
RAND
Collaborators
Louisiana Public Health Institute
Responsible party
Lisa Meredith (Senior Behavioral Scientist, RAND) — Principal investigator
First posted
Jul 18, 2018
Start date
Oct 12, 2018
Primary completion
Jul 2, 2019
Completion
Mar 30, 2020
Results posted
Dec 2, 2022
Last update
Dec 2, 2022

Study contacts

Lisa S Meredith, PhD
principal investigator · RAND

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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