NCT05477706

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

July 6, 2022

Last Update Submit

July 25, 2022

Conditions

Keywords

Peer-delivered InterventionPsychological DistressUnmet social needsRural Women VeteransPTSDDepressionSuicide riskTelehealthAnxiety

Outcome Measures

Primary Outcomes (2)

  • Change in actual engagement with social resource services and mental health treatment

    VHA Administrative data will be used to assess face-to-face and digital visits (encounters) along with self-reported number of visits on the Epidemiological Catchment Area Survey (ECA).

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

  • Change in perceived access to social resource services and mental health treatment

    The Assessment of Perceived Access to Care (APAC) measure will be used to assess perceived access to social resource services and mental health treatment at each time-point with a scale of 1-5 so that higher total scores equals better access.

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

Secondary Outcomes (10)

  • Veteran satisfaction

    6 Months (post-intervention) and 9 Months (3 Months post-intervention)

  • Change in depression symptoms

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

  • Change in social needs

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

  • Change in greater perceived progress on needs

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

  • Change in functioning

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

  • +5 more secondary outcomes

Other Outcomes (3)

  • Therapeutic alliance

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

  • Perceived Confidence

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

  • Autonomy Support

    Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)

Study Arms (2)

Personalized Support for Progress (PSP)

EXPERIMENTAL

PSP includes an initial 60-minute video or phone appointment and then follow-up tailored to the Veteran's preferences. The Peer Specialist guides the Veteran through a card-sorting task to prioritize concerns and then create a personalized care plan. The Peer then provides up to six months of outreach and support to implement the care plan. At the end of the six months, the Veteran and peer review the plan, determine next steps and consider other supports and resources to sustain progress made.

Other: Personalized Support for Progress (PSP)

Tailored Referral (TR)

ACTIVE COMPARATOR

The Tailored Referral (TR) comparator will be comprised of written or emailed information describing resources and contact information for VHA and local social and mental health resources. Examples include information about the appropriate office/person to reach within the local VA or area, help scheduling an appointment, or information for a same-day Primary Care - Mental Health Integration (PCMHI) assessment.

Other: Tailored Referral (TR)

Interventions

Personalized Support for Progress (PSP) is a Peer Specialist delivered intervention in which a peer supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services.

Personalized Support for Progress (PSP)

TR consists of detailed resource information and referral, consistent with standard practice.

Tailored Referral (TR)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identification as woman or gender fluid
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Any provider (physician, social worker, therapist, etc. with experience working with rural women Veterans) employed by the VHA
  • Any peer specialist employed by the VHA who identifies as a woman or as gender fluid

You may not qualify if:

  • 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)
  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (53)

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MeSH Terms

Conditions

DepressionStress Disorders, Post-TraumaticAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Ellen Poleshuck, PhD

    Syracuse VA Medical Center

    PRINCIPAL INVESTIGATOR
  • Derrecka Boykin, PhD

    Michael E. DeBakey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 28, 2022

Study Start

October 1, 2021

Primary Completion

January 1, 2024

Study Completion

October 1, 2024

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Once all data collection is complete and the coded database is finalized, individual participant data (IPD) will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
The data will be available once the database is finalized and will remain available in the future.
Access Criteria
Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.

Locations