Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03908190
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Emily M. Johnson, Syracuse VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Psychological Stress Life Stress Emotional Stress Behavioral: Personalized Support for Progress Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Masking Description: The interviewer evaluating progress towards goals will be blinded to condition.
Primary Purpose: Health Services Research
Official Title: Pilot Trial of Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
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
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 Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908190


Contacts
Layout table for location contacts
Contact: Emily M. Johnson, PhD 315-425-3487 emily.johnson1@va.gov

Locations
Layout table for location information
United States, New York
Syracuse VA Medical Center Recruiting
Syracuse, New York, United States, 13210
Contact: Emily M. Johnson, PhD         
Principal Investigator: Emily M. Johnson, PhD         
Sponsors and Collaborators
Syracuse VA Medical Center
US Department of Veterans Affairs

Layout table for additonal information
Responsible Party: Emily M. Johnson, Psychologist, Syracuse VA Medical Center
ClinicalTrials.gov Identifier: NCT03908190     History of Changes
Other Study ID Numbers: 1297981
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emily M. Johnson, Syracuse VA Medical Center:
Peer Support
Patient Navigators

Additional relevant MeSH terms:
Layout table for MeSH terms
Stress, Psychological
Behavioral Symptoms