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| Name | Class |
|---|---|
| Face the Fight | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Condition with intensive assessment | Experimental | Caring Contacts plus best available resources, with monthly EMAs during study year |
|
| Control Condition with intensive assessment | Active Comparator | Best available resources, with monthly EMAs during study year |
|
| Experimental Condition without intensive assessment | Experimental | Caring Contacts plus best available resources, without monthly EMAs during study year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caring Contacts | Behavioral | Caring Contacts are brief, periodic messages sent over 1 year that express unconditional care and concern |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suicide risk Visual Analog Scales (VAS) | Suicide risk indicators rated on Visual Analog Scales (VAS; 0-10) 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 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Potential Mechanism: Entrapment | A single item, "I feel trapped," acquired during Ecological Momentary Assessment periods. Min=1, max=7, higher score indicates increased feelings of entrapment. | 3 EMA assessments/day for 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition) |
Inclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Comtois, PhD/MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40801426 | Derived | Wright B, Evanson A, Casey C, Law KC, Rogers AH, Comtois KA. Exploring the Impact of the Caring Contacts Intervention on the Stress and Distress of Veterans and Service Members: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 13;14:e72140. doi: 10.2196/72140. |
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We will only make de-identified data and associated documentation available to users outside the research team under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Randomized Controlled Trial
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All outcome measures are completed by the participant via online survey.
| Best Available Resources Alone | Behavioral | 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. |
|
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 |
| Potential Mechanism: Personal and Social Responsibility | Responsibility Scale acquired during Ecological Momentary Assessment periods. Min=8, max=40, higher scores indicate greater sense personal and social responsibility. | 3 EMA assessments/day for 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition) |
| Potential Mechanism: Mattering | General Mattering Scale acquired during Ecological Momentary Assessment periods. Min=5, max=20, higher scores indicate greater sense of mattering. | 3 EMA assessments/day for 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition) |
| Potential Mechanism: Perceived Burdensomeness | A single item, "I felt that I was a burden to other people, or that they would be better off without me," acquired during Ecological Momentary Assessment periods. Min=1, max=7, higher score indicates increased feelings of burdensomeness. | 3 EMA assessments/day for 14 days at baseline; then either 3 EMA assessments/day for 7 days at 12 months OR 3 EMA assessments/day for 7 days/month for 12 months (depending on EMA condition) |