Caring Letters for Military Suicide Prevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01473771|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : June 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Suicide Suicide, Attempted||Behavioral: Caring Letter (email)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4730 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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.
Behavioral: Caring Letter (email)
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 Name: CLP
No Intervention: Usual Care (UC)
The participants in the Usual Care (UC) group will not receive the emails.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473771
|United States, California|
|Palo Alto VAHCS|
|Palo Alto, California, United States, 94304|
|Naval Medical Center San Diego (NMCSD)|
|San Diego, California, United States, 92134|
|United States, Hawaii|
|Tripler Army Medical Center (TAMC)|
|Honolulu, Hawaii, United States, 96859|
|United States, New York|
|VA Western New York, Buffalo VA Medical Center|
|Buffalo, New York, United States, 14215|
|United States, Washington|
|National Center for Telehealth and Technology|
|Tacoma, Washington, United States, 98431|
|Landstuhl Regional Medical Center|
|Landstuhl, Germany, 09180|
|Principal Investigator:||David D Luxton, PhD||National Center for Telehealth and Technology|