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Behavioral Intervention
STEP Home Workshop for Veteran Reintegration and Suicide Prevention (SH-SP Trial)
N/A
Recruiting
Led By Catherine B Fortier, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one year.
Awards & highlights
No Placebo-Only Group
Summary
This trial will develop a workshop to help transitioning Veterans get suicide prevention education, skills to manage transition, & support for VA healthcare to reduce suicide risk.
Who is the study for?
This trial is for recently transitioned Veterans within one year of leaving military service who are facing challenges adapting to civilian life. They must understand English well and agree to participate. Those with active psychosis, immediate high suicide risk, severe substance abuse (except mild cases), or neurological issues other than TBI cannot join.
What is being tested?
The STEP Home Workshop aims to help these Veterans by providing education on preventing suicide, skills for a smoother transition back into civilian life, support in accessing VA healthcare services, and reducing social isolation which could lower the risk of suicide.
What are the potential side effects?
Since this intervention is educational and supportive rather than medical or pharmaceutical, there may not be traditional side effects; however, discussing sensitive topics like suicide might cause emotional discomfort or distress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of one year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of one year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
Acceptability- Veteran adherence
Feasibility- Treatment Fidelity/adherence
+4 moreSecondary study objectives
Engagement in VA Care
Other study objectives
Attention-Related Cognitive Errors Scale (ARCES)
Depression- Patient Health Questionnaire (PHQ-9)
Difficulties in Emotional Regulation Scale (DERS)
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: STEP-Home-SP + Usual CareExperimental Treatment3 Interventions
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
Group II: Usual CareActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transition Assistance Program
2018
N/A
~350
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,663 Total Patients Enrolled
4 Trials studying Anger
313 Patients Enrolled for Anger
Catherine B Fortier, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
221 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I left the military service less than a year ago.I have a neurological condition, but it's not a traumatic brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: STEP-Home-SP + Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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