Clinical trial NCT04840134: From Hardship to Hope: A Peer-led Intervention to Reduce Financial Hardship and Suicide Risk
Official title: From Hardship to Hope: A Peer-led Intervention to Reduce Financial Hardship and Suicide Risk
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Suicide
Suicide Ideation
Suicidal Behavior
Hope
Financial Stress
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
name: Baltic Street Wellness Solutions
First posted: 2021-04-09
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Financial hardship is an important risk factor for suicide. However, to date there are no evidence-based interventions to help individuals improve their financial situation and thus reduce suicide risk. The aim of our study is to develop a 24-week, peer-led intervention to reduce financial hardship for individuals experiencing financial difficulties and suicide risk, and to test whether it is feasible, acceptable to clients and achieves its desired effect. The intervention will support participants to address their financial difficulties (e.g., debt, inability to meet basic needs) by coaching them on financial management techniques, facilitating a financial wellness plan, and connecting them with community- based financial supports (e.g., free financial counseling).

The intervention will be facilitated by trained peer coaches. The intervention will consist of three phases: (1) intensive; (2) intermediate; and (3) follow-up. The 6-week intensive phase will include 6 weekly group sessions and 4 one-on-one coaching sessions. The intermediate phase will consist of 3 biweekly group sessions and either 3 biweekly or 2 monthly one-on-one coaching sessions, based on participant preference. The follow-up phase will include 3 monthly group sessions and either 3 monthly or 6 biweekly one-on-one coaching sessions, also depending on participant preference. This study will obtain input from stakeholders to develop the intervention (Step 1), pilot it with a small sample of participants (n=10; Step 2), use this information to revise the intervention (Step 3), test it in a larger sample of individuals with financial hardship and suicide risk (n=48; Step 4), and prepare a final version of the intervention manual (Step 5). To date, the study has completed Steps 1-3. The main outcome of this study will be a manualized intervention to lessen financial hardship as a risk factor for suicide.

Detailed description: Decades of research have shown that financial hardship is a key risk factor for suicide. Studies have consistently found higher prevalence of suicidal ideation, suicide attempts, and suicide death among individuals experiencing financial hardship, such as unmanageable debts and difficulty paying for basic needs (e.g., housing, food). Stressful financial events (e.g., loss of income, evictions) are well-documented reasons for and precipitants of suicidal behavior. An increase in suicidal behavior is not only associated with objective aspects of financial hardship (e.g., number of debts, income level), but also with how hardship is experienced by individuals (e.g., financial threat, financial shame). In fact, growing evidence suggests that subjective financial hardship mediates the relationship between objective financial hardship and suicidal behavior.

Despite overwhelming evidence about the economic determinants of suicide, evidence-based interventions to reduce suicide risk and financial hardship are unavailable. Suicide prevention interventions at the individual level have largely focused on identifying or treating symptoms of psychiatric distress and other immediate clinical factors. Ecological-level interventions have mostly focused on increasing suicide awareness and reducing access to the means of suicide.

To address this gap, our project aims to develop a peer-led intervention that includes strategies and tools to reduce objective and subjective financial hardship, with the goal of decreasing hopelessness, shame, and depression (risk factors for suicide), increasing hope and life satisfaction (protective factors for suicide), and thereby reducing suicidal ideation and behaviors.

The main outcome of this study will be a manualized intervention to lessen financial hardship as a risk factor for suicidal ideation and behavior. If the findings of this study support its feasibility, acceptability, satisfaction, and initial efficacy, the investigators will formalize a peer coach training program, further develop an intervention fidelity measure, and pursue a randomized controlled trial to test intervention efficacy.

Specific aims and hypothesis are as follows:

1. With multi-stakeholder input, develop and iteratively revise From Hardship to Hope, a peer-led financial empowerment intervention with group and individual components to reduce SI/behaviors and financial hardship.
2. Assess the feasibility, acceptability, and satisfaction of the intervention using qualitative and quantitative methods.
3. Examine its initial efficacy by regular evaluations over 24 weeks on suicidal ideation (SI) severity and intensity, objective and subjective financial hardship, protective factors of suicide (e.g., hope, life satisfaction), and risk factors of suicide (e.g., hopelessness, depression). We hypothesize that SI severity and intensity, hopelessness, and objective and subjective financial hardship will decrease after the intervention while financial self-efficacy and hope will increase.
4. Explore the intervention's mechanisms of action (e.g., level of participation, subjective financial hardship). We hypothesize that the amount of change in SI severity and intensity will be positively correlated with the change in subjective financial hardship, and both will be associated with the level of participation.

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)).

Primary outcomes:
measure: TFA: Theoretical Framework of Acceptability (TFA) Questionnaire Change
timeFrame: Week 1, Week 6, Week 12, Week 24
measure: TEI-SF: Treatment Evaluation Inventory Change
timeFrame: Week 1, Week 6, Week 12, Week 24
Secondary outcomes:
measure: Columbia-Suicide Severity Rating Scale - Intensity of Ideation Sub-scale Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Beck Scale for Suicidal Ideation Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Economic Hardship Questionnaire Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: E-FwT: ENGAGE Financial Wellness Tool Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: InCharge Financial Distress/Financial Well-Being Scale (IFDFW) Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Financial Hardship Screener
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
Other outcomes:
measure: Financial Satisfaction Scale
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Financial Threat Scale Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Satisfaction with Life Scale Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Medical Outcomes Survey Social Support Scale (MOS-SSS) Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: UCLA Loneliness Scale-8 (ULS-8) Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: State Shame and Guilt Scale (SSGS)
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Beck Hopelessness Scale Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: E-SF: The Entrapment Scale Short-Form
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: Patient Health Questionnaire (PHQ-9) Change
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
measure: GAD-7: Generalized Anxiety Disorder 7-item
timeFrame: Baseline, Week 6, Week 12, Week 18, Week 24
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute, Columbia University Irving Medical Center
name: Oscar G Jimenez-Solomon, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: