Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic
Primary Purpose
Psychological Stress, Life Stress, Emotional Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Support for Progress
Sponsored by
About this trial
This is an interventional health services research trial for Psychological Stress focused on measuring Peer Support, Patient Navigators
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)
Sites / Locations
- Syracuse VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment As Usual
Treatment As Usual Plus Personalized Support for Progress
Arm Description
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.
In addition to treatment as usual, women will receive the Personalized Support for Progress intervention.
Outcomes
Primary Outcome Measures
Assessment Retention Rate
This is an assessment of trial feasibility.
Intervention Retention Rate
This is an assessment of trial feasibility.
Client Satisfaction Questionnaire
This scale measures satisfaction and ranges from 8-24 with higher scores indicating higher satisfaction.
Goal Attainment Scaling
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)
This scale evaluates perceived stress and ranges from 0-40 with lower scores indicating lower levels of perceived stress.
Secondary Outcome Measures
Full Information
NCT ID
NCT03908190
First Posted
October 24, 2018
Last Updated
March 15, 2021
Sponsor
Syracuse VA Medical Center
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT03908190
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
March 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse VA Medical Center
Collaborators
US Department of Veterans Affairs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Life Stress, Emotional Stress
Keywords
Peer Support, Patient Navigators
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
The interviewer evaluating progress towards goals will be blinded to condition.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment As Usual Plus Personalized Support for Progress
Arm Type
Experimental
Arm Description
In addition to treatment as usual, women will receive the Personalized Support for Progress intervention.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Support for Progress
Intervention Description
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 Outcome Measure Information:
Title
Assessment Retention Rate
Description
This is an assessment of trial feasibility.
Time Frame
6 months
Title
Intervention Retention Rate
Description
This is an assessment of trial feasibility.
Time Frame
6 months
Title
Client Satisfaction Questionnaire
Description
This scale measures satisfaction and ranges from 8-24 with higher scores indicating higher satisfaction.
Time Frame
6 months
Title
Goal Attainment Scaling
Description
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
Title
Perceived Stress Scale (PSS-10)
Description
This scale evaluates perceived stress and ranges from 0-40 with lower scores indicating lower levels of perceived stress.
Time Frame
6 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Any Veterans enrolled for care in the Syracuse VA Women's Wellness clinic because of biological sex or gender identity are eligible.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Syracuse VA Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic
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