Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT04007666
Eligibility Criteria:
Inclusion criteria for all participants:
* 18 years of age or older
* Able to understand and speak English
* Able to give informed consent
Inclusion criteria for key stakeholders/informants participating in Aims 1-3 (additional requirements):
* All items listed in "Inclusion criteria for all participants"
* Invited by the PI to participate, due to specific role within project sites (e.g., current Warden, treatment staff member, officer, study therapist)
Inclusion criteria for prisoners completing formative evaluation interviews in Aim 1 and pre-treatment assessments in Aim 3 (additional requirements):
* All items listed in "Inclusion criteria for all participants"
* Incarcerated in either East Central Arkansas Community Correction Center (ECACCC) or Northeast Arkansas Community Correction Center (NEACCC)
* Have a pre-incarceration history of substance use disorder
* Have a history of traumatic event exposure and self-report ongoing trauma-related difficulties
* Be within 9 months of release from incarceration
* Expect to reside in Arkansas throughout the study period
Inclusion criteria for prisoners to enroll in the Hybrid Trial in Aim 3 (additional requirements):
* All items listed in "Inclusion criteria for all participants"
* All items listed in "Inclusion criteria for prisoners completing pre-treatment assessments in Aim 3"
* Evidence clinically significant PTSD symptoms during pre-treatment (baseline) assessment per the Structured Clinical Interview for the DSM
* Have a pre-incarceration history of substance use disorder (confirmed by clinical interview)
Exclusion criteria for prisoners to enroll in the Hybrid Trial in Aim 3 (additional requirements):
* Unwilling to consent to randomization
* Unable to provide locator information for post-release assessments
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04007666
Study Brief:
Protocol Section:
NCT04007666