ClinicalTrials.gg
CompletedNCT03908190Updated Mar 16, 2021

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

An interventional study of Personalized Support for Progress in Psychological Stress, Life Stress and Emotional Stress, sponsored by Syracuse VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by Syracuse VA Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psychological Stress
  • Life Stress
  • Emotional Stress

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Keywords

  • Peer Support
  • Patient Navigators
03

In context

Stress, Psychological

806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.

This study's enrollment of 28 is below the median of 84 across 651 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Syracuse VA Medical Center is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralPersonalized 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.

06

What researchers measure

Primary outcomes

  1. Assessment Retention Rate

    This is an assessment of trial feasibility.

    Time frame: 6 months

  2. Intervention Retention Rate

    This is an assessment of trial feasibility.

    Time frame: 6 months

  3. Client Satisfaction Questionnaire

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

    Time frame: 6 months

  4. Goal Attainment Scaling

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

    Time frame: 6 months

  5. Perceived Stress Scale (PSS-10)

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

    Time frame: 6 months

07

Study locations

1 site
  • Syracuse VA Medical Center
    Syracuse, New York 13210, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Nov 2020, 12 months.

Of 444 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 12 months is below that.

Counting every sponsor, half of 456 studies reached it within 13 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2018
First posted
Apr 9, 2019
StartActual
Nov 13, 2019
Primary completionActual
Nov 16, 2020
CompletionActual
Mar 3, 2021
Last update
Mar 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03908190
Lead sponsor
Syracuse VA Medical Center
Responsible party
Emily M. Johnson (Psychologist, Syracuse VA Medical Center) — Principal investigator
First posted
Apr 9, 2019
Start date
Nov 13, 2019
Primary completion
Nov 16, 2020
Completion
Mar 3, 2021
Last update
Mar 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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