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Clinical Trials/NCT03908190
NCT03908190CompletedNot Applicable

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

Syracuse VA Medical Center2 sites in 1 country28 target enrollmentStarted: November 13, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Locations
2
Primary Endpoint
Assessment Retention Rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Masking Description

The interviewer evaluating progress towards goals will be blinded to condition.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Assessment Retention Rate

Time Frame: 6 months

This is an assessment of trial feasibility.

Intervention Retention Rate

Time Frame: 6 months

This is an assessment of trial feasibility.

Client Satisfaction Questionnaire

Time Frame: 6 months

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

Goal Attainment Scaling

Time Frame: 6 months

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

Perceived Stress Scale (PSS-10)

Time Frame: 6 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Syracuse VA Medical Center
Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Emily M. Johnson

Psychologist

Syracuse VA Medical Center

Study Sites (2)

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