Caring for Vets and Service Members: Caring Contacts for Stressed and Distressed Veterans and Service Members

Study Overview
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Brief Summary
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The goal of this clinical trial is to study stressed or distressed veterans and service members. Researchers will compare Caring Contacts plus best available resources to best available resources alone to see if reduces distress and prevents thoughts of suicide.

Detailed Description
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The objective of this study is to evaluate whether Caring Contacts via text message are beneficial to veterans and service members experiencing stress or distress. In the past, Caring Contacts interventions have focused on individuals who are already suicidal and not a more general population. In addition, a core objective of this study is to understand the mechanisms of action of Caring Contacts and thus has included an ecological momentary assessment (EMA) component that will allow us to determine when and how Caring Contacts is making an impact. Study aims are to Evaluate if stressed or distressed veterans receiving Caring Contacts are at greater or less risk of suicidal ideation or behavior as evidenced by: Decreased mean and reduction in variability of indicators of suicide risk (motivation to live, passive ideation, active ideation, suicide intent, and urges to harm self) acquired during Ecological Momentary Assessment periods. Reduced risk of suicidal ideation (HASS-I) and cognitions (SCS-R) during follow-up. Examine diverse veterans' experiences with Caring Contacts (i.e., access, satisfaction, preferences, potential mechanisms) Evaluate if veterans receiving Caring Contacts will show a decrease in distress (i.e., isolation, depression, substance use, loneliness, defeat, hopelessness, and psychological pain) Identify potential mechanisms of action for Caring Contacts by exploring the relationship between potential mechanisms (i.e., mattering, connectedness, social responsibility, and entrapment), distress, and suicide risk observed during ecological momentary assessment periods to identify potential mechanisms of action of Caring Contacts on decreasing distress and suicide risk

Official Title
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COVE (Caring for Vets and Service Members)

Conditions
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Stress, Distress, Emotional

Intervention / Treatment
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* Behavioral: Caring Contacts
* Behavioral: Best Available Resources Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: US service member or veteran 18 years or older Lives in the United States Stressed (recent separation from or in transition out of the military, unemployment, financial strain, unhoused, or suicide loss, etc.) or distressed (isolation, depression, substance use, loneliness, defeat, hopelessness, psychological pain, or suicidal ideation, etc.) Willingness to be contacted periodically by text message and either email or postal mail Exclusion Criteria: - Unable to consent due to inability to understand the consent form due to cognitive limitations or insufficient English (as determined by inability to pass the consent quiz items)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Condition<br>Caring Contacts plus best available resources | Behavioral: Caring Contacts<br>* Caring Contacts are brief, periodic messages sent over 1 year that express unconditional care and concern<br>Behavioral: Best Available Resources Alone<br>* Participants will be offered information about best available resources and will receive an email summarizing the resources with links and contact information. These resources are tailored to best serve the participant based on information they share during the online survey or during conversations with study staff.<br>|
| Active Comparator: Control Condition<br>Best available resources | Behavioral: Best Available Resources Alone<br>* Participants will be offered information about best available resources and will receive an email summarizing the resources with links and contact information. These resources are tailored to best serve the participant based on information they share during the online survey or during conversations with study staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide risk Visual Analog Scales (VAS) | Suicide risk indicators rated on Visual Analog Scales (VAS; 0-100) acquired during Ecological Momentary Assessment periods. Core constructs of suicide risk selected and worded to maximize face validity: motivation to live, passive ideation, active ideation, and urges for suicide. Higher scores indicate higher suicidal risk (motivation to live is reverse coded). | 3 EMA assessments/day for 7 days/month over 12 months | 
| Suicidal Ideation | Harkavy-Asnis Suicide Scale (HASS-I), adapted version for study procedures. Min=0, max=60, higher scores indicate higher suicidal ideation. | Baseline and 12 month follow-up | 
| Suicide Cognitions | Suicide Cognitions Scale - Revised, Min=16, max=80, higher scores indicate more suicidal cognitions. | Baseline and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of receiving Caring Contacts | Participants will be asked to describe their experiences with Caring Contacts via an online survey and a qualitative interview with a subset of participants | 12 month follow-up | 
| Depression | Patient Health Questionnaire-9 (PHQ-9), Min=0, max=30, higher scores indicate higher degree of depression severity. | Baseline and 12 month-up | 
| Substance Abuse | Short Inventory of Problems - Alcohol and Drugs (SIP-AD) | Baseline and 12 month follow-up | 
| Loneliness | NIH Loneliness Scale, Min=5, max=25, higher scores indicate increased loneliness. | Baseline and 12 month follow-up | 
| Defeat | The Defeat Scale, Min=0, max=64, higher scores indicate greater defeat. | Baseline and 12 month follow-up | 
| Hopelessness | Beck's Hopelessness Scale (BHS), Min=0, max=20, higher scores indicate greater hopelessness. | Baseline and 12 month follow-up | 
| Psychological Pain | Unbearable Psychache Scale-3 (UPS-3), Min=3, max=15, higher scores indicate greater psychological pain. | Baseline and 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suicidal ideation, suicide cognitions