Successful Transitions and Reintegration Tools for Veterans (START-VETS)

Study Overview
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Brief Summary
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This study will develop prison reentry materials for Veterans leaving prison.

Detailed Description
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This study will be conducted in three phases Phase 1is to collect qualitative data from Veterans who have recently been released from prison. The data will focus on their transition experience, stigma (both self and from others), and behaviors that interfered with success. Phase 2a will be to develop a transition program based around the needs identified in phase 1 Phase 2b will be to develop assessment tools to be used with the program Phase 3 will be to perform a two group randomized cross over design pilot study to assess the program

Official Title
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Development of a Psycho-social Transition Program and Transition Assessment Tools for Veterans With Mental Illness and/or Substance Use Disorders Leaving Prison

Conditions
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Substance Use Disorder, Mental Illness, Recently Incarcerated

Intervention / Treatment
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* Behavioral: START-VET
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran with mental illness and/or substance use disorder released from prison within the past 36 months Exclusion Criteria: psychosis or cognitive impairment precluding active participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Veterans will be randomly assigned to either begin an eight week (actual number of weeks is to be determined based on phase 2) active treatment program or to a no treatment phase. At eight weeks veterans will switch the condition they were assigned.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Monitoring/Treatment as usual<br>Veterans will not receive any study related interventions. | |
| Active Comparator: Reentry Program<br>Veterans will receive the START-VET reentry program | Behavioral: START-VET<br>* prison reentry program<br>Other: Treatment as usual<br>* This intervention involves no additional services above what is provided by the local health care system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Brief Symptom Inventory -18 | The Brief Symptom Inventory - 18 evaluates the domains of Somatization, Depression, and Anxiety. Each scale has 6 items, with a range of 0-24. Higher indicates a higher amount of the identified construct, i.e a worse outcome. | The Brief Symptom Inventory will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks. | 
| Change in the World Health Organization Quality of Life 100 | The World Health Organization Quality of Life 100 is a overall measure quality of life for participants. It has 5 domains: Physical (12 items, range 12-60), Psychological (18 items, range 18-90), Independence (16 items, range 16 - 80), Social (12 items, range 12-60), Environment (32 items, range 32-160), and Spiritual (4 items, range 4-20). Higher indicates higher levels of quality of life. | The World Health Organization Quality of Live 100 will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks. | 
| Inventory of Criminal Thinking Style | The Inventory of Criminal Thinking Styles (PICTS) is an 80-item self-report inventory designed to measure eight thinking styles presumed to reinforce, support, and maintain a criminal lifestyle. The eight thinking styles assessed by the PICTS are Mollification, Cutoff, Entitlement, Power Orientation, Superoptimism, Sentimentality, Cognitive Indolence, and Discontinuity. There are 10 items on each scale with scale scores ranging from 0 - 30. Higher indicates worse outcomes | The Inventory of Criminal Thinking Style will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reentry, Mental illness, prison, substance use disorder