Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs

Depression Clinical Trial

— EMBER  

Official title:

Use of a Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05477706
• Other study ID #: H-50334
• Secondary ID: 1652536
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2022
• Source: Syracuse VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 needs.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: October 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Aim 1 (Focus groups and interviews with women Veterans, Peer Specialists, and Providers to assess adaptations needed for PSP prior to the intervention trial) Inclusion Criteria:

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
• 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)

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
• 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.

Exclusion:

• 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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Distress
• PTSD

Intervention

Other:
• 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.
• Tailored Referral (TR)
TR consists of detailed resource information and referral, consistent with standard practice.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
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, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Therapeutic alliance	The Kim Alliance Scale (KAS-R) will be used to assess the quality of the therapeutic alliance between the Veteran and provider along with patient empowerment and satisfaction with the relationship.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Other	Perceived Confidence	The Perceived Confidence Scale will be used to assess each participants' feelings of confidence in engaging in tasks independently.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Other	Autonomy Support	The Autonomy Support Questionnaire will be used to assess each participants perceptions of autonomy support from their provider or peer.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Primary	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).	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Primary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	6 Months (post-intervention) and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)
Secondary	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.	Baseline, 6 Months (post-intervention), and 9 Months (3 Months post-intervention)