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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT04840134
Eligibility Criteria:
Inclusion Criteria:
* Working age (Self-reported age between 18-64).
* Provides informed consent (Self report: individual signs and dates Informed Consent Form).
* Stated willingness to comply with all study procedures and availability for the duration of the study (Self report).
* Lives or works in NYC (Self-report).
* Willing to receive referral to financial counseling (Self report).
* Objective financial hardship (Reports one or more types of financial hardship on the Financial Wellness Tool (FwTool), an 11-item assessment that measures overall financial hardship, food insecurity, housing hardship, difficulty paying for utilities, medical hardship, and indebtedness).
* Subjective financial hardship (Reports a Financial Threat score of 13 or higher \[5-25\] on the Financial Threat Scale (FTS), five-item scale that measures worry, fear, uncertainty, and preoccupation about one's financial situation).
* Moderate-to-high suicide risk as measured by the Columbia-Suicide Severity Rating Scale (C- SSRS) Screener administered by trained research staff (Endorses active suicidal ideation with or without a method or with some intent (items 2, 3, 4 on the C-SSRS) in the past 3 months, OR suicidal ideation with a plan or suicidal behavior (5 or 6 on the C-SSRS) in the past 3 months but NOT in the past month, confirmed by the study clinician during psychiatric evaluation).
* Receiving clinical treatment (Self-reports as currently enrolled in therapy or otherwise receiving treatment from a licensed mental health clinician; alternatively, willing to begin mental health treatment prior to the start of the intervention. Study participants will be asked to provide the name, phone number and email address for the treating clinician).
* Willing to participate in a financial wellness intervention via HIPAA-compliant videoconference platform (Self-report).
* Internet connection and video-capable device to participate in group sessions via HIPAA-compliant videoconference platform (Self-report).
Exclusion Criteria:
* Active SI with plan and intent in the past month (C-SSRS Screener administered by research staff and confirmed by study clinician (Yes to item 5, i.e., active suicidal ideation with plan and intent in the past month)).
* Recent suicidal behavior within the past month (C-SSRS Screener administered by research staff and confirmed by study clinician (Yes to item 6, i.e., has engaged in suicidal behaviors in the past month)).
* Florid psychosis or acute intoxication in need of detoxification (Clinical assessment by licensed study clinician during clinical evaluation).
* Cognitive impairment for those over age 60 (Montreal Cognitive Assessment - Blind Version (MoCA) conducted by research staff for those over age 60. (MoCA score below 19)).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04840134
Study Brief:
Protocol Section:
NCT04840134