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A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans (SH-SP)

Primary Purpose

TBI, Suicide Prevention, Veterans

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEP-Home-SP
Transition Assistance Program
VA Solid Start
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for TBI focused on measuring Veterans, TBI, Transdiagnostic, Intervention, Suicide Prevention, PTSD, Reintegration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Recently transitioned Veterans within one year of separation from military service Self-reported functional impairment or reintegration difficulties as measured by the Military-to-Civilian Questionnaire (any item score > 1 indicating "some difficulty"; M2CQ; [71]) Sufficient English fluency Agree to participate (informed consent/HIPAA) Exclusion Criteria: Active psychosis Imminent or acute high suicide risk requiring immediate crisis intervention (low-moderate non-imminent risk for suicide is allowed) Current moderate or severe substance use disorder Neurological diagnosis excluding TBI Participants with mild substance use disorder will be allowed Substance use is a common behavior that may contribute to reintegration difficulties and suicide risk

Sites / Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STEP-Home-SP + Usual Care

Usual Care

Arm Description

The core skills of emotional regulation and problem solving are introduced and integrated throughout all Veteran-specific reintegration content modules for practice and repetition for 12 weeks. Attention training augments emotional regulation and problem solving core skills and is interspersed throughout group and individual sessions. Additional 30-minute individual skill building and goal setting sessions occur ~4-6 times based on individual Veteran needs

UC will include the Transition Assistance Program (TAP) as scheduled by DOD prior to military separation, VA Solid Start post-separation, and educational augmentation post-separation.

Outcomes

Primary Outcome Measures

Feasibility- recruitment interest
ratio interested of those approached for the workshop
Feasibility- enrollment
Ratio enrolled (consented) of those approached, greater than 20% of those interested enroll in the proposed time frame
Feasibility- qualitative via Narrative Evaluation of Intervention Interview
Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview.
Feasibility- Treatment Fidelity/adherence
Supervisor and therapist Likert rating of adherence to content for core skills and treatment modules, less than 20% deviations on a treatment fidelity scale. Lower scores indicate stronger treatment fidelity, with each question being answered on a scale from 1 (Strongly Agree) to 5 (Strongly Disagree).
Acceptability- Veteran adherence
Attendance rate for the 12-session workshop
Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction. A priori criteria is that greater than 80% of participants will score greater that a 24 on the CSQ-8.
Reintegration status- Military to Civilian Questionnaire (M2CQ) Change
16 questions are answered on a scale from 0 (no difficulty) to 4 (extreme difficulty), with lower scores indicating more successful reintegration.

Secondary Outcome Measures

Engagement in VA Care
Electronic medical record data (if available) showing occurrence of one or more healthcare appointments

Full Information

First Posted
June 20, 2023
Last Updated
August 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05995678
Brief Title
A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans
Acronym
SH-SP
Official Title
A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2024 (Anticipated)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.
Detailed Description
Veterans face a "deadly gap" during their first year of transition from military to civilian life with limited available psychiatric services and increased suicide risk factors. During this critical transition period, Veteran suicide rate is double that of active service members and the general Veteran population. An average of 20 Veterans die from suicide each day, but only 6 of the 20 use VA services. VA care engagement has been shown to mitigate suicide risk; therefore, promoting engagement during the "deadly gap" could be essential to suicide prevention. Transitioning Veterans require outreach and services to provide them with support in their access to VA healthcare, suicide prevention education, and skills to manage their transition effectively. This proposal would bridge this important healthcare gap using STEP-Home. STEP-Home is an evidence-based, transdiagnostic, video telehealth rehabilitation workshop to improve reintegration, social support, and functioning among Veterans with high clinical comorbidity. STEP-Home is non-clinical, cost-effective, and skills-focused to maximally engage Veterans not participating in treatment who may be resistant to traditional "mental health" diagnostically focused approaches. To date, STEP-Home has not been adapted for the unique needs of recently transitioning Veterans or augmented for suicide prevention. This proposal will adapt and refine STEP-Home specifically for recently transitioning Veterans and add suicide prevention content and skills to create STEP-Home-SP. The proposed pilot study is designed to support STEP-Home and suicide prevention content experts in their refinement and evaluation of STEP-Home-SP. The investigators will utilize the VA/Department of Defense Identity Repository (VADIR) to recruit recently transitioned Veterans nationwide. In Aim 1, the investigators will develop STEP-Home-SP by adapting the STEP-Home telehealth intervention to specifically target recently transitioned Veterans and augment the workshop to include suicide prevention. In Aim 2, the investigators will conduct a two-arm proof-of-concept acceptability and feasibility randomized controlled trial (RCT) of STEP-Home-SP versus Enhanced Usual Care (EUC=current standard of care + educational packet on suicide risk and connection to VA care) in recently transitioned Veterans. Lastly, the investigators will explore reintegration status, VA care initiation, and candidate outcomes for STEP-Home-SP relative to EUC to inform a future full-scale RCT. If successful, fostering social, vocational, and community connection; building emotion regulation and impulse control skills; facilitating safety planning; and providing education and access to VA care upstream should result in decreased suicide risk during this critical transition and beyond.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI, Suicide Prevention, Veterans, PTSD, Transdiagnostic, Anger
Keywords
Veterans, TBI, Transdiagnostic, Intervention, Suicide Prevention, PTSD, Reintegration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Following T1 baseline assessment, participants will be randomized to STEP-Home-SP + Usual Care or Usual Care (UC) using randomly permuted block sizes stratified by presence or absence of SI.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEP-Home-SP + Usual Care
Arm Type
Experimental
Arm Description
The core skills of emotional regulation and problem solving are introduced and integrated throughout all Veteran-specific reintegration content modules for practice and repetition for 12 weeks. Attention training augments emotional regulation and problem solving core skills and is interspersed throughout group and individual sessions. Additional 30-minute individual skill building and goal setting sessions occur ~4-6 times based on individual Veteran needs
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
UC will include the Transition Assistance Program (TAP) as scheduled by DOD prior to military separation, VA Solid Start post-separation, and educational augmentation post-separation.
Intervention Type
Behavioral
Intervention Name(s)
STEP-Home-SP
Intervention Description
This group will meet for ~1.5 hours/week for 12 weeks. The core skills of Emotional Regulation (ER) and Problem Solving (PS) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention training augments ER and PS skills and is interspersed throughout the group and individual sessions. Additional 30-minute individual skills building and goal setting sessions occur up to 6 times based on individual Veteran needs. STEP-Home staff will work in pairs to run workshops per established protocols. Workshops will be conducted via VA approved video telehealth.
Intervention Type
Behavioral
Intervention Name(s)
Transition Assistance Program
Other Intervention Name(s)
TAP
Intervention Description
Provides training, skills, and information to help transitioning service members and their families prepare for the military to civilian transition. Each service member works with a TAP counselor to identify needs and post transition goals to build an Individual Transition Plan, in addition to TAP core curriculum courses.
Intervention Type
Behavioral
Intervention Name(s)
VA Solid Start
Intervention Description
VA Solid Start includes a series of outreach calls and emails to all Veterans at 90-, 180-, and 365-days post service separation. Callers follow a standard script to describe services available through VA and provide contact information for desired services.
Primary Outcome Measure Information:
Title
Feasibility- recruitment interest
Description
ratio interested of those approached for the workshop
Time Frame
Through study completion, an average of one year.
Title
Feasibility- enrollment
Description
Ratio enrolled (consented) of those approached, greater than 20% of those interested enroll in the proposed time frame
Time Frame
Through study completion, an average of one year.
Title
Feasibility- qualitative via Narrative Evaluation of Intervention Interview
Description
Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview.
Time Frame
Through study completion, an average of 3 months.
Title
Feasibility- Treatment Fidelity/adherence
Description
Supervisor and therapist Likert rating of adherence to content for core skills and treatment modules, less than 20% deviations on a treatment fidelity scale. Lower scores indicate stronger treatment fidelity, with each question being answered on a scale from 1 (Strongly Agree) to 5 (Strongly Disagree).
Time Frame
Through study completion, an average of 1 week.
Title
Acceptability- Veteran adherence
Description
Attendance rate for the 12-session workshop
Time Frame
Through study completion, an average of one year.
Title
Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
Description
Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction. A priori criteria is that greater than 80% of participants will score greater that a 24 on the CSQ-8.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Reintegration status- Military to Civilian Questionnaire (M2CQ) Change
Description
16 questions are answered on a scale from 0 (no difficulty) to 4 (extreme difficulty), with lower scores indicating more successful reintegration.
Time Frame
Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks)
Secondary Outcome Measure Information:
Title
Engagement in VA Care
Description
Electronic medical record data (if available) showing occurrence of one or more healthcare appointments
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Other Pre-specified Outcome Measures:
Title
Difficulties in Emotional Regulation Scale (DERS)
Description
36 statements are each ranked on the following scale by participants: 1 almost never (0-10%), 2 sometimes (11-35%), 3 about half the time (36-55%), 4 most of the time (66-90%), or 5 almost always (91-100%). This produces scores for 6 subscales: nonacceptance of emotional responses; difficulty engaging in goal-directed behavior; impulse control difficulties; lack of emotional awareness; limited access to emotion regulation strategies; lack of emotional clarity.
Time Frame
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Problem Solving Inventory (PSI)
Description
Participants rank 35 statements on a Likert scale from 1 (strongly agree) to 6 (strongly disagree). This generates a total score and 3 subscale scores for the following categories: Approach Avoidance, Personal Control, and Problem Solving Confidence.
Time Frame
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Attention-Related Cognitive Errors Scale (ARCES)
Description
12 questions are ranked on a Likert Scale from 1 (never) to 5 (very often) with higher scores indicating more frequent attention related cognitive errors.
Time Frame
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Suicidal Ideation- The Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Participants are asked 5 questions designed to assess severity of suicide risk. Questions are answered yes or no, with endorsement of active suicidal ideation with intent being considered high risk and suicidal ideation without intent considered moderate risk.
Time Frame
Assessed at screening, baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks). Will also be administered as needed following workshop sessions.
Title
Post-deployment Readjustment Inventory (PDRI)
Description
36 statements are ranked by participants on a scale from 1 (not at all) to 5 (extremely). Total score is calculated by the sum of each of the subscales: Career, Health, Intimate relationships, social readjustment, concerns about deployment, and PTSD symptoms. Higher scores indicate less successful post-deployment readjustment.
Time Frame
Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
State-Trait Anger Expression Inventory (STAXI-2)
Description
Measures the experience, expression, and control of anger. Participants rank each of the statements on a scale of 1 (not at all) to 4 (very much so) for section 1 and 1 (almost never) to 4 (almost always) for sections 2 and 3. Higher scores indicate high experience/expression and low control of anger.
Time Frame
Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Functional status measured using the WHO Disability Assessment Schedule 2.0 12-item (WHODAS-2.0)
Description
Participants indicate how much difficulty they have had in the last 30 days for each of the statements on the assessment on a scale from 0 (none) to 4 (Extreme/cannot do). Higher scores indicate greater levels of disability.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Stigma- Perceived Barriers to Care Survey
Description
Participants rank each of the survey items on the scale from 1 (strongly agree) to 5 (strongly disagree) with lower scores indicating that the item is a greater barrier to care.
Time Frame
Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Quality of Life Scale (QOLS)
Description
Participants answer each question on a 7 point scale. It is scored by adding up the score on each item to get a minimum potential score of 16 and a maximum total score of 112. Higher scores indicate a higher quality of life.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Psychosocial Functioning- The Brief Inventory of Psychosocial Functioning (IPF-Brief)
Description
Participants rank each of the 7 statements based on their overall experience over the past month on a scale from 0 (not at all) to 6 (very much). 7 is marked if the statement is not applicable. Higher scores indicate more impaired psychosocial functioning.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Social support subscale of the Deployment Risk and Resilience Inventory (DRRI-2)
Description
Participants rank each of the ten questions from this subscale on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree) and total subscale score is calculated by adding up the responses from each of the questions. Lower scores indicate lower levels of social support.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Interpersonal Needs Questionnaire (INQ)
Description
Each of the 15 questions are answered on a scale from 1 (Not at all true for me) to 7 (very true for me). 6 out of the 15 questions are reverse coded. Higher scores indicate that more interpersonal needs are not met.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Depression- Patient Health Questionnaire (PHQ-9)
Description
Participants rank 9 questions on a scale from 0 (not at all) to 3 (Nearly every day) based on how often in the last 2 weeks they have been bothered by the problems listed. Then they rate the severity of the difficulty any problems they have experienced are causing on a scale from "not difficult at all" to "extremely difficult." Higher scores indicate higher depression severity.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Hopelessness- Beck Hopelessness Scale
Description
Participants answer 20 true or false questions that are scored based on an answer key. Answers that indicate hopelessness are added up, with higher scores indicating higher levels of hopelessness/pessimism.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Self-injurious thoughts and behaviors interview (SITBI)
Description
This interview asks a wide variety of questions related to suicidal ideations, plans, gestures, attempts, and non-suicidal self injurious behaviors. There are 72 possible questions, but some are only asked if a specific behavior is endorsed. Higher scores indicate higher levels of thoughts and feelings related to suicide and self-injurious behaviors.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Suicide Coping/Safety Behaviors- Suicide Related Coping Scale (SRCS)
Description
Participants answer 17 questions on a 5 point Likert scale from 0-4 (Strongly Disagree to Strongly Agree). Total score is determined by reverse scoring negatively worded items and then summing the items. Higher scores indicate better coping skills.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Gateway to vocational and community activities- Treatment & Activities Survey
Description
Treatment & Activities Survey developed by STEP-Home staff asks participants to list the types of treatment (psychotherapy, medication, group therapy) that they have participated in within the last month, what they receive the treatment for, and whether it is administered by the VA or outside of the VA. Participants also answer if they have participated in other activities in the last month (school, work, community, etc.) and whether those activities are at or outside of the VA.
Time Frame
Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Title
Kessler-6 brief mental health screen
Description
The Kessler Psychological Distress Scale (K6) is a 6 item measure of participants' emotional state. Questions are scored from 0 (none of the time) to 4 (all of the time) with a minimum score of 0 and a maximum score of 24. Higher scores indicate higher levels of psychological distress.
Time Frame
Baseline (0 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Recently transitioned Veterans within one year of separation from military service Self-reported functional impairment or reintegration difficulties as measured by the Military-to-Civilian Questionnaire (any item score > 1 indicating "some difficulty"; M2CQ; [71]) Sufficient English fluency Agree to participate (informed consent/HIPAA) Exclusion Criteria: Active psychosis Imminent or acute high suicide risk requiring immediate crisis intervention (low-moderate non-imminent risk for suicide is allowed) Current moderate or severe substance use disorder Neurological diagnosis excluding TBI Participants with mild substance use disorder will be allowed Substance use is a common behavior that may contribute to reintegration difficulties and suicide risk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine B Fortier, PhD
Phone
(857) 364-4361
Email
catherine.fortier@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine B Fortier, PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine B Fortier, PhD
Phone
857-364-4361
Email
catherine.fortier@va.gov
First Name & Middle Initial & Last Name & Degree
Catherine B Fortier, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.

Learn more about this trial

A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

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