Caring Letters for Military Suicide Prevention
Primary Purpose
Suicide, Suicide, Attempted
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Caring Letter (email)
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Suicide, Suicide, Attempted
Eligibility Criteria
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
Sites / Locations
- Palo Alto VAHCS
- Naval Medical Center San Diego (NMCSD)
- Tripler Army Medical Center (TAMC)
- VA Western New York, Buffalo VA Medical Center
- National Center for Telehealth and Technology
- Landstuhl Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Caring Letter Condition (CL)
Usual Care (UC)
Arm Description
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.
The participants in the Usual Care (UC) group will not receive the emails.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to Suicidal Behavior
This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utilization over the previous two years.
Full Information
NCT ID
NCT01473771
First Posted
November 14, 2011
Last Updated
August 21, 2018
Sponsor
National Center for Telehealth and Technology
Collaborators
United States Department of Defense, U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT01473771
Brief Title
Caring Letters for Military Suicide Prevention
Official Title
Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Telehealth and Technology
Collaborators
United States Department of Defense, U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide, Attempted
Keywords
Suicide, Suicide, Attempted
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caring Letter Condition (CL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
The participants in the Usual Care (UC) group will not receive the emails.
Intervention Type
Behavioral
Intervention Name(s)
Caring Letter (email)
Other Intervention Name(s)
CLP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicide Mortality Rates
Description
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.
Time Frame
Study Completion (2 years)
Secondary Outcome Measure Information:
Title
Time to Suicidal Behavior
Description
This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utilization over the previous two years.
Time Frame
Study Completion (2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David D Luxton, PhD
Organizational Affiliation
National Center for Telehealth and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto VAHCS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Naval Medical Center San Diego (NMCSD)
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Tripler Army Medical Center (TAMC)
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Facility Name
VA Western New York, Buffalo VA Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
National Center for Telehealth and Technology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Landstuhl Regional Medical Center
City
Landstuhl
ZIP/Postal Code
09180
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
Reger, MA, Luxton DD, Skopp, NA, Lee, JA, Gahm, GA. Department of Defense Suicide Event Report (DoDSER): Calendar Year 2008 Annual Report: National Center for Telehealth and Technology, Defense Centers of Excellence for Psychological Health and TBI; 2009
Results Reference
background
Citation
Luxton, DD, Skopp, NA, Kinn, JT, Bush, NE, Reger, MA, Gahm, GA. Department of Defense Suicide Event Report: Calendar Year 2009 Annual Report. Edited by Defense Centers of Excellence for Psychological Health & TBI (DCoE) National Center for Telehealth & Technology (T2); 2010.
Results Reference
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Citation
National Violent Death Reporting System: Centers for Disease Control and Prevention; 2009
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Citation
Joiner TE, Van Orden KA. The interpersonal-psychological theory of suicidal behavior indicates specific and crucial psychotherapeutic targets. International Journal of Cognitive Psychology 2008;1(1):80-89.
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PubMed Identifier
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Caring Letters for Military Suicide Prevention
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