Clinical trial NCT05477706: Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs
Official title: Use of a Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Distress
Depression
PTSD
Anxiety
Keywords: Peer-delivered Intervention
Psychological Distress
Unmet social needs
Rural Women Veterans
PTSD
Depression
Suicide risk
Telehealth
Anxiety
Lead sponsor: Syracuse VA Medical Center
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2022-07-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social needs.

Detailed description: Not only do rural women Veterans report significant psychological distress (PTSD, anxiety, depression, suicide risk) and social needs (housing, transportation, material insecurity), they also experience substantial barriers accessing services which limits the Veteran Health Administration's (VHA) ability to address their needs. Personalized Support for Progress (PSP) is a virtually delivered intervention in which a Peer Specialist supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services. This trial is investigating whether PSP with rural women Veterans is associated with improved perceived access and actual engagement to mental health and social resource services, as well as high satisfaction and improved mental health, social needs and function outcomes. Rural women Veterans of color are more likely to be coping with psychological distress and social needs, as well as experiencing barriers to engagement and retention in services. Therefore this trial is designed to ensure that PSP delivery is tailored to increase rural women Veterans of color's acceptability.

The primary study design is a randomized controlled trial of Tailored Referral Information (TR) compared to Personalized Support for Progress (PSP) intervention for rural women Veterans with psychological distress and social needs (Aim 2). Prior to implementing the trial, focus groups and individual interviews will be conducted with women Veterans, Peer Specialists, and providers/stakeholders to determine any needed adaptations to determine any needed adaptations of PSP delivery for rural women Veterans and for PSP implementation in rural primary care clinics (Aim 1).

Eligibility criteria: Aim 1 (Focus groups and interviews with women Veterans, Peer Specialists, and Providers to assess adaptations needed for PSP prior to the intervention trial)

Inclusion Criteria:

Veteran Inclusion:

* Veteran status (non-Veterans will not be enrolled in this trial)
* Identifies as a woman or as gender fluid
* Resides in a rural or highly rural area
* Psychological distress in the past 6 months as evidenced by a diagnosis in the electronic health record or elevated score on the PHQ-9, GAD-7 and/or PCL
* At least one social need in the past 6 months on the PRAPARE
* Ability to communicate in English including reading, writing, hearing, and speaking well enough to complete research and intervention tasks.

Providers Inclusion Criteria:

• Any provider (physician, social worker, therapist, etc. with experience working with rural women Veterans) employed by the VHA

Peers inclusion criteria:

•Any peer specialist employed by the VHA who identifies as a woman or as gender fluid

Veteran Exclusion Criteria:

* Any Veteran with high suicide or homicide risk and/or evaluated by the PI or another clinician to be clinically unstable
* Veterans with impairment that would not allow them to engage in study activities including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in electronic health record or reported by a primary care clinician team member)

Aim 2 (Randomized controlled trial of PSP compared to TR)

Inclusion:

* Veteran status (non-Veterans will not be enrolled in this trial)
* Identifies as a woman or as gender fluid
* Resides in a rural or highly rural area
* Veteran must reside in Southeastern Texas, Arkansas or Louisiana
* Psychological distress in the past 6 months as evidenced by a diagnosis in the electronic health record or elevated score on the PHQ-9, GAD-7 and/or PCL
* At least one social need in the past 6 months on the PRAPARE
* Ability to communicate in English including reading, writing, hearing, and speaking well enough to complete research and intervention tasks.

Exclusion:

* Any Veteran with high suicide or homicide risk and/or evaluated by the PI or another clinician to be clinically unstable
* Veterans with impairment that would not allow them to engage in study activities including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in EMR or reported by a PACT member)
* Veterans who have current VA or non-VA peer support engagement (an appointment within the last month and/or additional follow-up scheduled)

Primary outcomes:
measure: Change in actual engagement with social resource services and mental health treatment
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in perceived access to social resource services and mental health treatment
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary outcomes:
measure: Veteran satisfaction
timeFrame: 6 Months (post-intervention) and 9 Months (3 Months post-intervention)
measure: Change in depression symptoms
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in social needs
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in greater perceived progress on needs
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in functioning
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in Perception of Quality of Life
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Stigma-related beliefs about mental health
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in perceived stress
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in anxiety symptoms
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Change in Post-Traumatic Stress Disorder (PTSD) symptoms
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Other outcomes:
measure: Therapeutic alliance
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Perceived Confidence
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
measure: Autonomy Support
timeFrame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center
state: New York
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Syracuse VA Medical Center
name: Ellen Poleshuck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michael E. DeBakey Medical Center
name: Derrecka Boykin, PhD
role: PRINCIPAL_INVESTIGATOR
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