Caring Letters for Military Suicide Prevention

Study Overview
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Brief Summary
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The purpose of this multi-site randomized controlled trial is to determine if the Caring Letters intervention is effective in preventing suicide and suicidal behaviors among U.S. Service Members and Veterans. The primary aim of this project is determine whether caring communications following inpatient psychiatric treatment reduce suicide and self-inflicted injuries among U.S. military personnel and Veterans. The investigators will also explore treatment utilization by comparing the frequency of treatment visits after enrollment into the study. The following specific hypotheses will be tested: Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency of suicide will be lower among participants in the Caring Letters group compared to those in the Usual Care group. Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower in the Caring Letters group compared to the Usual Care group. Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be longer among participants in the Caring Letters group compared to the Usual Care group.

Detailed Description
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This social/ behavioral study is a five year multi-site randomized controlled trial that will compare the Caring Letters intervention (with usual care) to usual care without the caring letters. Participants will be recruited from inpatient psychiatry units of collaborating military and Veterans Affairs (VA) sites and randomized to either a group that receives letters (Caring Letters group) or a group that does not receive letters (Usual Care group). The methodology of the intervention is updated with emails instead of postal letters. This study fills an important gap in the evidence base for the Caring Letter intervention through a methodologically rigorous research design.

Official Title
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Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

Conditions
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Suicide, Suicide, Attempted

Intervention / Treatment
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* Behavioral: Caring Letter (email)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current psychiatric inpatients Possess an active email account Informed consent Active duty military, Veteran, Retiree, National Guard or Reserves status Exclusion Criteria: Not competent to consent Adverse behavioral problems The primary psychiatric nurse or attending psychiatrist considers that study to be clinically inappropriate Currently under arrest/incarceration Involuntary committed for psychiatric care status

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caring Letter Condition (CL)<br>In the Caring Letters (CL) group, participants will be emailed letters for two years on a planned schedule. The emailed letters are simple expressions of care and include standard contact information for available health care services. | Behavioral: Caring Letter (email)<br>* Participants will be emailed letters for two years. The first letter will be sent one week afer discharge from the inpatient psychiatric unit. There will be four subsequent email letters sent every month starting from the day of discharge, then another four every two months. The last four email letters will be sent every three months for the remainder of the two year period.<br>* Other names: CLP;|
| No Intervention: Usual Care (UC)<br>The participants in the Usual Care (UC) group will not receive the emails. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide Mortality Rates | Death Certificates as recorded in the Center for Disease Control (CDC's) National Death Index Plus(NDI-Plus) will be reviewed. The Social Security Administration Master Death File will also be used. | Study Completion (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Suicidal Behavior | This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utilization over the previous two years. | Study Completion (2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide, Suicide, Attempted