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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT05427734
Eligibility Criteria:
Inclusion Criteria:
* Resides in the United States
* 22+ years of age
* English speaking
* At risk for suicide, as evidenced by at least one of the following:
* One or more lifetime suicide attempts (ASQ item 4)
* Endorsement of any ASQ items 1 -3 (expanded from "past few weeks" in ASQ to "past 30 days" in our measures)
* Item 1: In the past 30 days, have you wished you were dead?
* Item 2: In the past 30 days, have you felt that you or your family would be better off if you were dead?
* Item 3: In the 30 days, have you been having thoughts about killing yourself?
* Currently has a primary care provider and sought care from them in the past year
* Possesses and is the primary user of an Android- or iPhone-based smartphone with a data plan
Given that alcohol misuse exponentially increases the risk of death by suicide, can exacerbate other problems, and interfere with effective treatment, we will over-recruit individuals who misuse alcohol to ensure relevance of the tool for them. No fewer than 35% of the sample will be comprised of individuals who score 8 or more on the Alcohol Use Disorders Identification Test (AUDIT), indicating a harmful or hazardous level of drinking.
To ensure a sufficient sample of individuals who misuse alcohol, no fewer than 35% of the sample will be comprised of individuals who score 8 or more on the Alcohol Use Disorders Identification Test (AUDIT), indicating a harmful or hazardous level of drinking.
Exclusion Criteria:
* Severe depression (PHQ-9 score of 20 or greater)
* Alcohol dependence (AUDIT score of 32 or greater)
* Acutely suicidal (affirms item 5 of the Ask Suicide Screening Questions; Are you having thoughts of killing yourself right now? Followed by endorsing intent; Have you intended to act on urges to kill yourself in the past 30 days? or planning within the past 30 days; Have you made a plan to kill yourself in the past 30 days?)
* Significant drug abuse problems (scores 6 or greater on the DAST-10)
Individuals who are excluded because of the severity of their depression, suicide acuity, and/or degree of substance use disorder will be provided with resources (i.e., the Suicide and Crisis Lifeline (988), SAMHSA's National Helpline) and encouraged to reach out to their primary care or mental/behavioral health provider.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05427734
Study Brief:
Protocol Section:
NCT05427734