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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT02755103
Eligibility Criteria:
Inclusion Criteria:
* Women between 18 and 65 years of age enrolled in the Charleston Center (CC) intensive outpatient and New Life program treatment.
* Able to comprehend English.
* Meets fifth edition Diagnostic and Statistical Manual V (DSM V) criteria for current alcohol or substance use disorder and have used alcohol/substances in the 30 days prior to clinic treatment entry.
* Meets DSM V criteria for current PTSD with a score greater than or equal to 25 on the CAPS 5.0.
* Participants may also meet criteria for a mood or anxiety disorder. Participants on psychotropic medications for a mood or anxiety disorder must have been stabilized on medications for at least 4 weeks before therapy initiation.
* Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
* Willing to commit to 8 therapy sessions, baseline, weekly and follow-up assessments.
Exclusion Criteria:
* Current primary psychotic or thought disorder (i.e. Schizophrenia or schizoaffective disorder, mania), major depression with suicidal ideation, dissociative identity disorder and/or homicidal ideations.
* Present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study.
* In ongoing therapy for PTSD either within or outside of the CC, who are not willing to discontinue these therapies for the duration of the study therapy,
* Unstable medical condition or one that may require hospitalization during the course of the study.
* Women who are pregnant or planning to become pregnant.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02755103
Study Brief:
Protocol Section:
NCT02755103