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Completed

NCT Number: NCT03908190

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.

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Emotional Stress Life Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Assessment Retention Rate

    Time frame: 6 months

    This is an assessment of trial feasibility.

  2. Intervention Retention Rate

    Time frame: 6 months

    This is an assessment of trial feasibility.

  3. Client Satisfaction Questionnaire

    Time frame: 6 months

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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Syracuse VA Medical Center

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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