Caring Letters for Military Suicide Prevention

Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1319

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Landstuhl, Germany, 09180
        • Landstuhl Regional Medical Center
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto VAHCS
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego (NMCSD)
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center (TAMC)
    • New York
      • Buffalo, New York, United States, 14215
        • VA Western New York, Buffalo VA Medical Center
    • Washington
      • Tacoma, Washington, United States, 98431
        • National Center for Telehealth and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caring Letter Condition (CL)
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.
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.
Other Names:
  • CLP
No Intervention: Usual Care (UC)
The participants in the Usual Care (UC) group will not receive the emails.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicide Mortality Rates
Time Frame: Study Completion (2 years)
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
Time Frame: Study Completion (2 years)
This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utilization over the previous two years.
Study Completion (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David D Luxton, PhD, National Center for Telehealth and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 16, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • W81XWH-11-2-0123
  • MOMRP (Other Grant/Funding Number: W81XWH-11-2-0123)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Caring Letter (email)

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