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

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

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.

Study Overview

• Status: Completed
• Conditions: Emotional Stress; Psychological Stress; Life Stress
• Intervention / Treatment: Behavioral: Personalized Support for Progress

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • Syracuse VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual; 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.
Experimental: Treatment As Usual Plus Personalized Support for Progress; In addition to treatment as usual, women will receive the Personalized Support for Progress intervention.	Behavioral: Personalized Support for Progress; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Syracuse VA Medical Center
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Peer Support; Patient Navigators
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 1297981

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No