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Substance Use DisorderSTART-VETNCT04366531

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

A study testing START-VET and Treatment as usual in people with Substance Use Disorder and Mental Illness, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This study will develop prison reentry materials for Veterans leaving prison. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
START-VET and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
3 Aug 2020to 1 Jun 2027
Phase
Interventional

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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Veteran with mental illness and/or substance use disorder released from prison within the past 36 months

Who cannot join

  • Psychosis or cognitive impairment precluding active participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

April Crawford, MS contact

(214) 857-2571

april.crawford@va.gov

United States1 site, 1 recruiting
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167

    April Crawford, MS, (214) 857-2571, april.crawford@va.gov

    James P. LePage, PhD

    Recruiting

Other trials in United States

About this study

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

This study will develop prison reentry materials for Veterans leaving prison.

Read the detailed description

This study will be conducted in three phases:

Phase 1 is 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

Being tested
START-VET, Treatment as usual
Keywords
reentry, Mental illness, prison, substance use disorder
Medical subject headings
Substance-Related Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • START-VETBehavioural

    prison reentry program

  • Treatment as usualOther

    This intervention involves no additional services above what is provided by the local health care system

Study groups in NCT04366531
Study groupRoleWhat they receive
Monitoring/Treatment as usualNo interventionVeterans will not receive any study related interventions.
Reentry ProgramActive comparatorVeterans will receive the START-VET reentry program
Receives: Behavioral: START-VET; Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The Brief Symptom Inventory will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks.

  2. 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.

    Measured: 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.

  3. 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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start3 Aug 2020
  3. Primary completion5 Feb 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04366531
Sponsor's protocol ID
D3225-R
Other IDs
5I01RX003225-03
Acronym
START-VET
Status last verified
Oct 2026
First submitted
22 Apr 2020
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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