Clinical trial NCT03908190: Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic
Official title: Pilot Trial of Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Life Stress
Emotional Stress
Keywords: Peer Support
Patient Navigators
Lead sponsor: Syracuse VA Medical Center
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2019-04-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment Retention Rate
timeFrame: 6 months
measure: Intervention Retention Rate
timeFrame: 6 months
measure: Client Satisfaction Questionnaire
timeFrame: 6 months
measure: Goal Attainment Scaling
timeFrame: 6 months
measure: Perceived Stress Scale (PSS-10)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center
state: New York
Study officials:
References: