Clinical trial NCT01473771: Caring Letters for Military Suicide Prevention
Official title: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide, Attempted
Keywords: Suicide
Suicide, Attempted
Lead sponsor: National Center for Telehealth and Technology
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: U.S. Army Medical Research and Development Command
First posted: 2011-11-17
Enrollment: 1319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Suicide Mortality Rates
timeFrame: Study Completion (2 years)
Secondary outcomes:
measure: Time to Suicidal Behavior
timeFrame: Study Completion (2 years)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto VAHCS
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego (NMCSD)
state: California
city: Honolulu
country: United States
facility: Tripler Army Medical Center (TAMC)
state: Hawaii
city: Buffalo
country: United States
facility: VA Western New York, Buffalo VA Medical Center
state: New York
city: Tacoma
country: United States
facility: National Center for Telehealth and Technology
state: Washington
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
Study officials:
affiliation: National Center for Telehealth and Technology
name: David D Luxton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
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