Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic

NCT03908190 | Completed

• 1 other identifier: 1297981
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the Personalized Support for Progress (PSP) intervention in a Veterans Health Administration (VHA) Women's Wellness Clinic. PSP uses a peer support provider to help women identify their primary concern, develop a personalized plan to help address that concern, and provide practical and emotional support to implement the plan. The primary aim is to evaluate the feasibility, acceptability, and utility of PSP and the research protocol.

Conditions

Psychological Stress; Life Stress; Emotional Stress

Keywords

Peer Support; Patient Navigators

Outcome Measures

Primary Outcomes (5)

• Assessment Retention Rate

  This is an assessment of trial feasibility.

  6 months

• Intervention Retention Rate

  This is an assessment of trial feasibility.

  6 months

• Client Satisfaction Questionnaire

  This scale measures satisfaction and ranges from 8-24 with higher scores indicating higher satisfaction.

  6 months

• Goal Attainment Scaling

  This interview assesses progress toward individualized goals on a -2 to 2 scale with higher scores indicating more progress toward goals.

  6 months

• Perceived Stress Scale (PSS-10)

  This scale evaluates perceived stress and ranges from 0-40 with lower scores indicating lower levels of perceived stress.

  6 months

Study Arms (2)

Treatment As Usual

NO INTERVENTION

Participants will receive treatment as usual within the VHA Women's Wellness Clinic including any appropriate treatment or treatments for their medical and psychosocial concerns as determined by their primary care teams.

Treatment As Usual Plus Personalized Support for Progress

EXPERIMENTAL

In addition to treatment as usual, women will receive the Personalized Support for Progress intervention.

Behavioral: Personalized Support for Progress

Interventions

Personalized Support for Progress BEHAVIORAL

Participants will receive the Personalized Support for Progress Intervention from a peer support provider including sessions with the peer support provider to complete a prioritization task, develop a personalized care plan, and receive support for implementing the personalized care plan.

Treatment As Usual Plus Personalized Support for Progress

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Any Veterans enrolled for care in the Syracuse VA Women's Wellness clinic because of biological sex or gender identity are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran status (non-Veterans will not be enrolled in this trial)
• Enrollment in the Syracuse VA Medical Center Women's Wellness Clinic
• Report high stress within the last month (Perceived Stress Scale \[PSS-10\] \> 18)
• Primary Care Provider approval for participation
• Ability to communicate in English including reading, writing, hearing, and speaking well enough to complete research and intervention tasks.

You may not qualify if:

• Any Veteran with "higher" suicide risk on the P4 or Veterans with "lower" suicide risk on the P4 and evaluated by the PI or another clinician to be clinically unstable or at risk
• Homicidality (screened via adaptation of the P4 screener and evaluated on the same criteria above)
• Homelessness (including literally homeless, imminent risk of homelessness, or fleeing/attempting to flee domestic violence per VA definitions)
• Veterans who are enrolled in or have had psychotherapy or changes to psychotropic medications in the last 12 weeks
• Veterans with impairment that would not allow them to engage in PSP including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in CPRS or reported by a PACT member)
• Veterans who are not available for outpatient PSP meetings (e.g., in a residential program)
• Veterans who have current VA or non-VA peer support engagement (an appointment within the last month and/or additional follow-up scheduled)

Sponsors & Collaborators

• Syracuse VA Medical Center: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The interviewer evaluating progress towards goals will be blinded to condition.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: April 9, 2019
• Study Start: November 13, 2019
• Primary Completion: November 16, 2020
• Study Completion: March 3, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

US (1)