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

Trauma-informed Collaborative Care for Low-income African Americans With Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03591107
Enrollment
42
Registered
2018-07-18
Start date
2018-10-12
Completion date
2020-03-30
Last updated
2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Brief 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.

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.

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

Sponsors

Louisiana Public Health Institute
CollaboratorOTHER
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Recruitment Coordinators/Data Collectors will only recruit at one of the two sites. The baseline assessment will be conducted prior to random assignment. After the assessment, they will be aware of study assignment which is necessary for connecting patients assigned to the PCM arm to connect patients to the Care Manager. However, they will only conduct 6-month assessments with patients from the other site and therefore will not be aware of the assignments for those patients.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
PCL-5 Symptom Score0 monthstotal 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 Diagnosis0 monthscount/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)

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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. 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
19
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. Minimally Enhanced Usual Care (MEU): Education and feedback alone
21
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDischarged from clinic01
Overall StudySame patient in both arms11
Overall StudySought care at other clinics02
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicPTSD Care Management (PCM)Minimally Enhanced Usual Care (MEU)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
19 Participants21 Participants40 Participants
Born in the United States18 Participants21 Participants39 Participants
Education
College degree or graduate
9 Participants2 Participants11 Participants
Education
< High school
2 Participants10 Participants12 Participants
Education
High school graduate/GED
8 Participants9 Participants17 Participants
Health comorbidity
Alcohol use
0 Participants1 Participants1 Participants
Health comorbidity
Cancer
0 Participants0 Participants0 Participants
Health comorbidity
Depression
6 Participants5 Participants11 Participants
Health comorbidity
Diabetes
6 Participants6 Participants12 Participants
Health comorbidity
Drug use
0 Participants0 Participants0 Participants
Health comorbidity
Heart conditions
0 Participants1 Participants1 Participants
Health comorbidity
Hypertension
2 Participants2 Participants4 Participants
Health comorbidity
Neurological disorders
0 Participants0 Participants0 Participants
Health comorbidity
Psychoses (
0 Participants4 Participants4 Participants
Marital status
Married or unmarried couple
1 Participants3 Participants4 Participants
Marital status
Separated/divorced/widowed
5 Participants8 Participants13 Participants
Marital status
Single
13 Participants10 Participants23 Participants
Race/Ethnicity, Customized
African American
19 Participants21 Participants40 Participants
Sex: Female, Male
Female
16 Participants16 Participants32 Participants
Sex: Female, Male
Male
3 Participants5 Participants8 Participants
Type of medical insurance
Employer/private
1 Participants1 Participants2 Participants
Type of medical insurance
Medicaid
15 Participants18 Participants33 Participants
Type of medical insurance
Medicare
2 Participants1 Participants3 Participants
Type of medical insurance
No insurance
1 Participants0 Participants1 Participants
Type of medical insurance
Other (Medicaid and Medicare)
0 Participants1 Participants1 Participants
Years lived in the United States39.84 Years
STANDARD_DEVIATION 11.6
45.38 Years
STANDARD_DEVIATION 12.5
42.75 Years
STANDARD_DEVIATION 12.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 21
other
Total, other adverse events
1 / 190 / 21
serious
Total, serious adverse events
3 / 195 / 21

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
PTSD Care Management (PCM)PCL-5 Symptom Score73.32 score on a scaleStandard Deviation 13.7
Minimally Enhanced Usual Care (MEU)PCL-5 Symptom Score72.95 score on a scaleStandard Deviation 14.3
Primary

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

ArmMeasureValue (MEAN)Dispersion
PTSD Care Management (PCM)PCL-5 Symptom Score37.07 score on a scaleStandard Deviation 17.8
Minimally Enhanced Usual Care (MEU)PCL-5 Symptom Score47.27 score on a scaleStandard Deviation 15.5
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PTSD Care Management (PCM)Provisional PTSD Diagnosis19 Participants
Minimally Enhanced Usual Care (MEU)Provisional PTSD Diagnosis21 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PTSD Care Management (PCM)Provisional PTSD Diagnosis8 Participants
Minimally Enhanced Usual Care (MEU)Provisional PTSD Diagnosis14 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026