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

Psychological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908190
• Other study ID #: 1297981
• Status: Completed
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: March 3, 2021

Study information

• Verified date: March 2021
• Source: Syracuse VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 3, 2021
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emotional Stress
• Life Stress
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Personalized 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.

Locations

Country	Name	City	State
United States	Syracuse VA Medical Center	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Syracuse VA Medical Center	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment Retention Rate	This is an assessment of trial feasibility.	6 months
Primary	Intervention Retention Rate	This is an assessment of trial feasibility.	6 months
Primary	Client Satisfaction Questionnaire	This scale measures satisfaction and ranges from 8-24 with higher scores indicating higher satisfaction.	6 months
Primary	Goal Attainment Scaling	This interview assesses progress toward individualized goals on a -2 to 2 scale with higher scores indicating more progress toward goals.	6 months
Primary	Perceived Stress Scale (PSS-10)	This scale evaluates perceived stress and ranges from 0-40 with lower scores indicating lower levels of perceived stress.	6 months