Psychological DistressEMBERNCT05477706
Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs
A study testing Personalized Support for Progress (PSP) and Tailored Referral (TR) in people with Psychological Distress and Depression, run by Syracuse VA Medical Center at 2 sites in United States.
Trial summary
This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Psychological Distress, Depression, PTSD
- What is being tested?
- Personalized Support for Progress (PSP) and Tailored Referral (TR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2021to 1 Oct 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran Inclusion:
- Veteran status (non-Veterans will not be enrolled in this trial)
- Identifies as a woman or as gender fluid
- Resides in a rural or highly rural area
- Psychological distress in the past 6 months as evidenced by a diagnosis in the electronic health record or elevated score on the PHQ-9, GAD-7 and/or PCL
- At least one social need in the past 6 months on the PRAPARE
Show all 22Show fewer
- Ability to communicate in English including reading, writing, hearing, and speaking well enough to complete research and intervention tasks.
- Providers Inclusion Criteria:
- Any provider (physician, social worker, therapist, etc. with experience working with rural women Veterans) employed by the VHA
- Peers inclusion criteria:
- •Any peer specialist employed by the VHA who identifies as a woman or as gender fluid
- Veteran Exclusion Criteria:
- Any Veteran with high suicide or homicide risk and/or evaluated by the PI or another clinician to be clinically unstable
- Veterans with impairment that would not allow them to engage in study activities including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in electronic health record or reported by a primary care clinician team member)
- Aim 2 (Randomized controlled trial of PSP compared to TR)
- Veteran status (non-Veterans will not be enrolled in this trial)
- Identifies as a woman or as gender fluid
- Resides in a rural or highly rural area
- Veteran must reside in Southeastern Texas, Arkansas or Louisiana
- Psychological distress in the past 6 months as evidenced by a diagnosis in the electronic health record or elevated score on the PHQ-9, GAD-7 and/or PCL
- At least one social need in the past 6 months on the PRAPARE
- 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 high suicide or homicide risk and/or evaluated by the PI or another clinician to be clinically unstable
- Veterans with impairment that would not allow them to engage in study activities including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in EMR or reported by a PACT member)
- 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
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Syracuse VA Medical Center
Syracuse, New York, 13210
About this study
Official title: Use of a Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs
This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social needs.
Read the detailed description
Not only do rural women Veterans report significant psychological distress (PTSD, anxiety, depression, suicide risk) and social needs (housing, transportation, material insecurity), they also experience substantial barriers accessing services which limits the Veteran Health Administration's (VHA) ability to address their needs. Personalized Support for Progress (PSP) is a virtually delivered intervention in which a Peer Specialist supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services. This trial is investigating whether PSP with rural women Veterans is associated with improved perceived access and actual engagement to mental health and social resource services, as well as high satisfaction and improved mental health, social needs and function outcomes. Rural women Veterans of color are more likely to be coping with psychological distress and social needs, as well as experiencing barriers to engagement and retention in services. Therefore this trial is designed to ensure that PSP delivery is tailored to increase rural women Veterans of color's acceptability.
The primary study design is a randomized controlled trial of Tailored Referral Information (TR) compared to Personalized Support for Progress (PSP) intervention for rural women Veterans with psychological distress and social needs (Aim 2). Prior to implementing the trial, focus groups and individual interviews will be conducted with women Veterans, Peer Specialists, and providers/stakeholders to determine any needed adaptations to determine any needed adaptations of PSP delivery for rural women Veterans and for PSP implementation in rural primary care clinics (Aim 1).
- Conditions
- Psychological Distress, Depression, PTSD, Anxiety
- Being tested
- Personalized Support for Progress (PSP), Tailored Referral (TR)
- Keywords
- Peer-delivered Intervention, Psychological Distress, Unmet social needs, Rural Women Veterans, PTSD, Depression, Suicide risk, Telehealth, Anxiety
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Support for Progress (PSP)Other
Personalized Support for Progress (PSP) is a Peer Specialist delivered intervention in which a peer supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services.
Tailored Referral (TR)Other
TR consists of detailed resource information and referral, consistent with standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Support for Progress (PSP) | Experimental | PSP includes an initial 60-minute video or phone appointment and then follow-up tailored to the Veteran's preferences. The Peer Specialist guides the Veteran through a card-sorting task to prioritize concerns and then create a personalized care plan. The Peer then provides up to six months of outreach and support to implement the care plan. At the end of the six months, the Veteran and peer review the plan, determine next steps and consider other supports and resources to sustain progress made. Receives: Other: Personalized Support for Progress (PSP) |
| Tailored Referral (TR) | Active comparator | The Tailored Referral (TR) comparator will be comprised of written or emailed information describing resources and contact information for VHA and local social and mental health resources. Examples include information about the appropriate office/person to reach within the local VA or area, help scheduling an appointment, or information for a same-day Primary Care - Mental Health Integration (PCMHI) assessment. Receives: Other: Tailored Referral (TR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in actual engagement with social resource services and mental health treatment
VHA Administrative data will be used to assess face-to-face and digital visits (encounters) along with self-reported number of visits on the Epidemiological Catchment Area Survey (ECA).
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in perceived access to social resource services and mental health treatment
The Assessment of Perceived Access to Care (APAC) measure will be used to assess perceived access to social resource services and mental health treatment at each time-point with a scale of 1-5 so that higher total scores equals better access.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary outcomes (10)
Veteran satisfaction
Veteran satisfaction will be measures using the Client Satisfaction Questionnaire-8 (CSQ-8), an 8 item measure of participant satisfaction with services. An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: 6 Months (post-intervention) and 9 Months (3 Months post-intervention)
Change in depression symptoms
Change in depression symptoms for Veteran participants will be assessed using the Patient Health Questionnaire (PHQ)-9, a self-administered depression scale. The total score can range from 1 to 27 with a higher score indicating more severe depression.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in social needs
Change in social needs will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), a standardized tool for collecting social determinants of health (SDH) data including socioeconomic and psychosocial characteristics. The total score can range from 0 to 22 with the total cumulative score indicating presence of risk and unmet needs.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in greater perceived progress on needs
An adapted version of the Goal Attainment Scale (GAS) will be used to assess Veteran perceived progress on needs. The GAS is a functional scale used to measure the extent of progress towards individual goals during the course of an intervention. Each subject has their own outcome measures but they are scored in a standardized way. Scale items are based on current and expected levels of performance.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in functioning
The Brief Inventory of Psychosocial Functioning (B-IPF) will be used to measure change in functioning. The B-IPF is an 7-item self-report instrument measuring PTSD-related functional impairment in the past 30 days by looking at seven functional domains including romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care. Items are scored on a Likert scale from 0 to 6. The B-IPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100. The B-IPF represents an overall index of functioning, with higher scores indicating greater functional impairment.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in Perception of Quality of Life
The World Health Organization Quality of Life (WHO-QOL) measure will be used to assess quality of life (QOL) for each participant in the context of culture, value systems, personal goals, standards and concerns. The scale is scored between 0 to 100 with higher scores indicating a higher quality of life.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Stigma-related beliefs about mental health
The Endorsed and Anticipated Stigma Inventory (EASI) is a tool for assessing beliefs about mental illness and mental health treatment among Veterans. The scales are scored so that higher scores are indicative of greater stigma.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in perceived stress
The Perceived Stress Scale (PSS) will be used to measure each participants subjective understanding of their psychological stress level in the past month. Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in anxiety symptoms
Change in anxiety symptoms for Veteran participants will be assessed using the Generalized Anxiety Disorder (GAD)-7, a seven-item instrument used to measure the severity of generalized anxiety disorder (GAD). The total score can range from 0 to 21 with a higher score indicating a larger amount of anxiety symptoms.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in Post-Traumatic Stress Disorder (PTSD) symptoms
Change in PTSD symptoms for Veteran participants will be assessed using the Post Traumatic Stress Disorder (PTSD) Checklist (PCL-5), a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual-5 symptoms of PTSD. For this trial a score of 31 or higher indicates a positive screen for PTSD.
Measured: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Oct 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syracuse VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Ellen Poleshuck, PhD, Principal investigator, Syracuse VA Medical CenterDerrecka Boykin, PhD, Principal investigator, Michael E. DeBakey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477706
- Sponsor's protocol ID
- H-50334
- Other IDs
- 1652536
- Acronym
- EMBER
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all data collection is complete and the coded database is finalized, individual participant data (IPD) will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.
Publications
Fortney JC, Pyne JM, Hawrilenko M, Bechtel JM, Moore D, Nolan JP, Pfeiffer P, Shushan S, Shore JH, Bowen D. Psychometric Properties of the Assessment of Perceived Access to Care (APAC) Instrument. J Ambul Care Manage. 2021 Jan/Mar;44(1):31-45. doi: 10.1097/JAC.0000000000000358.
PubMed 33165120Moreau JL, Cordasco KM, Young AS, Oishi SM, Rose DE, Canelo I, Yano EM, Haskell SG, Hamilton AB. The Use of Telemental Health to Meet the Mental Health Needs of Women Using Department of Veterans Affairs Services. Womens Health Issues. 2018 Mar-Apr;28(2):181-187. doi: 10.1016/j.whi.2017.12.005. Epub 2018 Jan 12.
PubMed 29339013Cordasco KM, Mengeling MA, Yano EM, Washington DL. Health and Health Care Access of Rural Women Veterans: Findings From the National Survey of Women Veterans. J Rural Health. 2016 Sep;32(4):397-406. doi: 10.1111/jrh.12197. Epub 2016 Jul 28.
PubMed 27466970McCarthy JF, Blow FC, Ignacio RV, Ilgen MA, Austin KL, Valenstein M. Suicide among patients in the Veterans Affairs health system: rural-urban differences in rates, risks, and methods. Am J Public Health. 2012 Mar;102 Suppl 1(Suppl 1):S111-7. doi: 10.2105/AJPH.2011.300463. Epub 2012 Jan 25.
PubMed 22390583Thomas KH, McDaniel, J.T., Haring, E.L., Albright, D.L., Fletcher, K.L. Mental health needs of military and veteran women: An assessment conducted by the Service Women's Action Network. Traumatology. 2018;24(2):104-112.
Thomas KH, Turner, L.W., Kaufman, E.M., Paschal, A., Knowlden, A.P., Birch, D.A., Leeper, J.D. Predictors of Depression Diagnoses and Symptoms in Veterans: Results From a National Survey. Military Behavioral Health. 2015;3(4):255-265.
Tsai J, Kasprow WJ, Kane V, Rosenheck RA. National comparison of literally homeless male and female VA service users: entry characteristics, clinical needs, and service patterns. Womens Health Issues. 2014 Jan-Feb;24(1):e29-35. doi: 10.1016/j.whi.2013.09.007. Epub 2013 Dec 15.
PubMed 24342077Brooks E, Novins DK, Thomas D, Jiang L, Nagamoto HT, Dailey N, Bair B, Shore JH. Personal characteristics affecting veterans' use of services for posttraumatic stress disorder. Psychiatr Serv. 2012 Sep 1;63(9):862-7. doi: 10.1176/appi.ps.201100444.
PubMed 22707088Renteria-Szelwach C, Steinkogler, J., Badger, E.R., & Muttukumaru, R. Transitioning to the Civilian Workforce: Issues Impacting the Reentry of Rural Women Veterans. Journal of Rural Social Sciences. 2011;26(3).
Lehavot K, Beckman KL, Chen JA, Simpson TL, Williams EC. Race/Ethnicity and Sexual Orientation Disparities in Mental Health, Sexism, and Social Support among Women Veterans. Psychol Sex Orientat Gend Divers. 2019;6(3):347-358. doi: 10.1037/sgd0000333.
PubMed 31435497Montgomery AE, Tsai J, Blosnich JR. Demographic Correlates of Veterans' Adverse Social Determinants of Health. Am J Prev Med. 2020 Dec;59(6):828-836. doi: 10.1016/j.amepre.2020.05.024. Epub 2020 Nov 18.
PubMed 33220754Montgomery AE, Szymkowiak, D., & Tsai, J. Housing Instability and Homeless Program Use Among Veterans: The Intersection of Race, Sex, and Homelessness. Housing Policy Debate. 2020;30(3):396-408.
Spoont M, Nelson D, van Ryn M, Alegria M. Racial and Ethnic Variation in Perceptions of VA Mental Health Providers are Associated With Treatment Retention Among Veterans With PTSD. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S33-S42. doi: 10.1097/MLR.0000000000000755.
PubMed 28806364Brooks E, Dailey N, Bair B, Shore J. Rural women veterans demographic report: defining VA users' health and health care access in rural areas. J Rural Health. 2014 Spring;30(2):146-52. doi: 10.1111/jrh.12037. Epub 2013 Jul 19.
PubMed 24689540Washington DL, Bean-Mayberry B, Riopelle D, Yano EM. Access to care for women veterans: delayed healthcare and unmet need. J Gen Intern Med. 2011 Nov;26 Suppl 2(Suppl 2):655-61. doi: 10.1007/s11606-011-1772-z.
PubMed 21989618
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs
- ClinicalTrials.gov ID
- NCT05477706
- Acronym / sponsor ID
- EMBER / H-50334
- Conditions
- Psychological Distress, Depression, PTSD, Anxiety
- Keywords
- Peer-delivered Intervention, Psychological Distress, Unmet social needs, Rural Women Veterans, PTSD, Depression, Suicide risk, Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Syracuse VA Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 28 Jul 2022 (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.
This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social needs.
Detailed description
Not only do rural women Veterans report significant psychological distress (PTSD, anxiety, depression, suicide risk) and social needs (housing, transportation, material insecurity), they also experience substantial barriers accessing services which limits the Veteran Health Administration's (VHA) ability to address their needs. Personalized Support for Progress (PSP) is a virtually delivered intervention in which a Peer Specialist supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services. This trial is investigating whether PSP with rural women Veterans is associated with improved perceived access and actual engagement to mental health and social resource services, as well as high satisfaction and improved mental health, social needs and function outcomes. Rural women Veterans of color are more likely to be coping with psychological distress and social needs, as well as experiencing barriers to engagement and retention in services. Therefore this trial is designed to ensure that PSP delivery is tailored to increase rural women Veterans of color's acceptability.
The primary study design is a randomized controlled trial of Tailored Referral Information (TR) compared to Personalized Support for Progress (PSP) intervention for rural women Veterans with psychological distress and social needs (Aim 2). Prior to implementing the trial, focus groups and individual interviews will be conducted with women Veterans, Peer Specialists, and providers/stakeholders to determine any needed adaptations to determine any needed adaptations of PSP delivery for rural women Veterans and for PSP implementation in rural primary care clinics (Aim 1).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Personalized Support for Progress (PSP) | Experimental | Other: Personalized Support for Progress (PSP)PSP includes an initial 60-minute video or phone appointment and then follow-up tailored to the Veteran's preferences. The Peer Specialist guides the Veteran through a card-sorting task to prioritize concerns and then create a personalized care plan. The Peer then provides up to six months of outreach and support to implement the care plan. At the end of the six months, the Veteran and peer review the plan, determine next steps and consider other supports and resources to sustain progress made. |
| Tailored Referral (TR) | Active comparator | Other: Tailored Referral (TR)The Tailored Referral (TR) comparator will be comprised of written or emailed information describing resources and contact information for VHA and local social and mental health resources. Examples include information about the appropriate office/person to reach within the local VA or area, help scheduling an appointment, or information for a same-day Primary Care - Mental Health Integration (PCMHI) assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Veteran status (non-Veterans will not be enrolled in this trial)
- Identifies as a woman or as gender fluid
- Resides in a rural or highly rural area
- Psychological distress in the past 6 months as evidenced by a diagnosis in the electronic health record or elevated score on the PHQ-9, GAD-7 and/or PCL
- At least one social need in the past 6 months on the PRAPARE
Key exclusion criteria (3 listed)
- Any Veteran with high suicide or homicide risk and/or evaluated by the PI or another clinician to be clinically unstable
- Veterans with impairment that would not allow them to engage in study activities including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in EMR or reported by a PACT member)
- Veterans who have current VA or non-VA peer support engagement (an appointment within the last month and/or additional follow-up scheduled)
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 Progress (PSP)Personalized Support for Progress (PSP) is a Peer Specialist delivered intervention in which a peer supports Veterans in prioritizing their needs and attaining access to the Veterans' preferred services. | Other | Personalized Support for Progress (PSP) |
| Tailored Referral (TR)TR consists of detailed resource information and referral, consistent with standard practice. | Other | Tailored Referral (TR) |
Primary outcome
Change in actual engagement with social resource services and mental health treatment
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
VHA Administrative data will be used to assess face-to-face and digital visits (encounters) along with self-reported number of visits on the Epidemiological Catchment Area Survey (ECA).
Change in perceived access to social resource services and mental health treatment
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
The Assessment of Perceived Access to Care (APAC) measure will be used to assess perceived access to social resource services and mental health treatment at each time-point with a scale of 1-5 so that higher total scores equals better access.
10 secondary outcomes
Veteran satisfaction
Time frame: 6 Months (post-intervention) and 9 Months (3 Months post-intervention)
Change in depression symptoms
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in social needs
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in greater perceived progress on needs
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in functioning
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in Perception of Quality of Life
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Stigma-related beliefs about mental health
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in perceived stress
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in anxiety symptoms
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Change in Post-Traumatic Stress Disorder (PTSD) symptoms
Time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 33165120Fortney JC, Pyne JM, Hawrilenko M, Bechtel JM, Moore D, Nolan JP, Pfeiffer P, Shushan S, Shore JH, Bowen D. Psychometric Properties of the Assessment of Perceived Access to Care (APAC) Instrument. J Ambul Care Manage. 2021 Jan/Mar;44(1):31-45. doi: 10.1097/JAC.0000000000000358.
- Background: PubMed 29339013Moreau JL, Cordasco KM, Young AS, Oishi SM, Rose DE, Canelo I, Yano EM, Haskell SG, Hamilton AB. The Use of Telemental Health to Meet the Mental Health Needs of Women Using Department of Veterans Affairs Services. Womens Health Issues. 2018 Mar-Apr;28(2):181-187. doi: 10.1016/j.whi.2017.12.005. Epub 2018 Jan 12.
- Background: PubMed 27466970Cordasco KM, Mengeling MA, Yano EM, Washington DL. Health and Health Care Access of Rural Women Veterans: Findings From the National Survey of Women Veterans. J Rural Health. 2016 Sep;32(4):397-406. doi: 10.1111/jrh.12197. Epub 2016 Jul 28.
- Background: PubMed 22390583McCarthy JF, Blow FC, Ignacio RV, Ilgen MA, Austin KL, Valenstein M. Suicide among patients in the Veterans Affairs health system: rural-urban differences in rates, risks, and methods. Am J Public Health. 2012 Mar;102 Suppl 1(Suppl 1):S111-7. doi: 10.2105/AJPH.2011.300463. Epub 2012 Jan 25.
- BackgroundThomas KH, McDaniel, J.T., Haring, E.L., Albright, D.L., Fletcher, K.L. Mental health needs of military and veteran women: An assessment conducted by the Service Women's Action Network. Traumatology. 2018;24(2):104-112.
- BackgroundThomas KH, Turner, L.W., Kaufman, E.M., Paschal, A., Knowlden, A.P., Birch, D.A., Leeper, J.D. Predictors of Depression Diagnoses and Symptoms in Veterans: Results From a National Survey. Military Behavioral Health. 2015;3(4):255-265.
- Background: PubMed 24342077Tsai J, Kasprow WJ, Kane V, Rosenheck RA. National comparison of literally homeless male and female VA service users: entry characteristics, clinical needs, and service patterns. Womens Health Issues. 2014 Jan-Feb;24(1):e29-35. doi: 10.1016/j.whi.2013.09.007. Epub 2013 Dec 15.
- Background: PubMed 22707088Brooks E, Novins DK, Thomas D, Jiang L, Nagamoto HT, Dailey N, Bair B, Shore JH. Personal characteristics affecting veterans' use of services for posttraumatic stress disorder. Psychiatr Serv. 2012 Sep 1;63(9):862-7. doi: 10.1176/appi.ps.201100444.
- BackgroundRenteria-Szelwach C, Steinkogler, J., Badger, E.R., & Muttukumaru, R. Transitioning to the Civilian Workforce: Issues Impacting the Reentry of Rural Women Veterans. Journal of Rural Social Sciences. 2011;26(3).
- Background: PubMed 31435497Lehavot K, Beckman KL, Chen JA, Simpson TL, Williams EC. Race/Ethnicity and Sexual Orientation Disparities in Mental Health, Sexism, and Social Support among Women Veterans. Psychol Sex Orientat Gend Divers. 2019;6(3):347-358. doi: 10.1037/sgd0000333.
- Background: PubMed 33220754Montgomery AE, Tsai J, Blosnich JR. Demographic Correlates of Veterans' Adverse Social Determinants of Health. Am J Prev Med. 2020 Dec;59(6):828-836. doi: 10.1016/j.amepre.2020.05.024. Epub 2020 Nov 18.
- BackgroundMontgomery AE, Szymkowiak, D., & Tsai, J. Housing Instability and Homeless Program Use Among Veterans: The Intersection of Race, Sex, and Homelessness. Housing Policy Debate. 2020;30(3):396-408.
- Individual participant dataSharing planned: Yes. Once all data collection is complete and the coded database is finalized, individual participant data (IPD) will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.
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Breast Cancer
Not yet recruiting
Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates
Psychological Distress
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.
Ellen Poleshuck, PhD principal investigator
Syracuse VA Medical Center
Derrecka Boykin, PhD principal investigator
Michael E. DeBakey Medical Center
2 sites 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 (PSP) and Tailored Referral (TR) in people with Psychological Distress and Depression, run by Syracuse VA Medical Center at 2 sites 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 22 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Change in actual engagement with social resource services and mental health treatment (time frame: Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477706, which also lists 53 linked publications.
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 28 Jul 2022.