Psychological StressNCT03908190
Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic
A study testing Personalized Support for Progress in people with Psychological Stress and Life Stress, run by Syracuse VA Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress, Life Stress, Emotional Stress
- What is being tested?
- Personalized Support for Progress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 3 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse VA Medical Center
Syracuse, New York, 13210
About this study
Official title: Pilot Trial of 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.
- Conditions
- Psychological Stress, Life Stress, Emotional Stress
- Being tested
- Personalized Support for Progress
- Keywords
- Peer Support, Patient Navigators
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Support for ProgressBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | No intervention | 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. |
| Treatment As Usual Plus Personalized Support for Progress | Experimental | In addition to treatment as usual, women will receive the Personalized Support for Progress intervention. Receives: Behavioral: Personalized Support for Progress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment Retention Rate
This is an assessment of trial feasibility.
Measured: 6 months
Intervention Retention Rate
This is an assessment of trial feasibility.
Measured: 6 months
Client Satisfaction Questionnaire
This scale measures satisfaction and ranges from 8-24 with higher scores indicating higher satisfaction.
Measured: 6 months
Goal Attainment Scaling
This interview assesses progress toward individualized goals on a -2 to 2 scale with higher scores indicating more progress toward goals.
Measured: 6 months
Perceived Stress Scale (PSS-10)
This scale evaluates perceived stress and ranges from 0-40 with lower scores indicating lower levels of perceived stress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start13 Nov 2019
- Primary completion16 Nov 2020
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Emily M. Johnson, Syracuse VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908190
- Sponsor's protocol ID
- 1297981
- Status last verified
- Mar 2021
- First submitted
- 24 Oct 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Personalized Support for Progress (PSP) in a VA Women's Wellness Clinic
- ClinicalTrials.gov ID
- NCT03908190
- Acronym / sponsor ID
- 1297981
- Conditions
- Psychological Stress, Life Stress, Emotional Stress
- Keywords
- Peer Support, Patient Navigators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Syracuse VA Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | No intervention | –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. |
| Treatment As Usual Plus Personalized Support for Progress | Experimental | Behavioral: Personalized Support for ProgressIn addition to treatment as usual, women will receive the Personalized Support for Progress intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Support for ProgressParticipants 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. | Behavioural | Treatment As Usual Plus Personalized Support for Progress |
Primary outcome
Assessment Retention Rate
Time frame: 6 months
This is an assessment of trial feasibility.
Intervention Retention Rate
Time frame: 6 months
This is an assessment of trial feasibility.
Client Satisfaction Questionnaire
Time frame: 6 months
This scale measures satisfaction and ranges from 8-24 with higher scores indicating higher satisfaction.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Support for Progress in people with Psychological Stress and Life Stress, run by Syracuse VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment Retention Rate (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.