- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01473771
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Landstuhl, Germany, 09180
- Landstuhl Regional Medical Center
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California
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Palo Alto, California, United States, 94304
- Palo Alto VAHCS
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San Diego, California, United States, 92134
- Naval Medical Center San Diego (NMCSD)
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Hawaii
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Honolulu, Hawaii, United States, 96859
- Tripler Army Medical Center (TAMC)
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New York
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Buffalo, New York, United States, 14215
- VA Western New York, Buffalo VA Medical Center
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Washington
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Tacoma, Washington, United States, 98431
- National Center for Telehealth and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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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:
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No Intervention: Usual Care (UC)
The participants in the Usual Care (UC) group will not receive the emails.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide Mortality Rates
Time Frame: Study Completion (2 years)
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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.
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Study Completion (2 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Suicidal Behavior
Time Frame: Study Completion (2 years)
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This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utilization over the previous two years.
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Study Completion (2 years)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David D Luxton, PhD, National Center for Telehealth and Technology
Publications and helpful links
General Publications
- 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
- 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.
- National Violent Death Reporting System: Centers for Disease Control and Prevention; 2009
- 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.
- Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge project: randomised controlled trial of an intervention using postcards to reduce repetition of hospital treated deliberate self poisoning. BMJ. 2005 Oct 8;331(7520):805. doi: 10.1136/bmj.38579.455266.E0. Epub 2005 Sep 23.
- Fleischmann A, Bertolote JM, Wasserman D, De Leo D, Bolhari J, Botega NJ, De Silva D, Phillips M, Vijayakumar L, Varnik A, Schlebusch L, Thanh HT. Effectiveness of brief intervention and contact for suicide attempters: a randomized controlled trial in five countries. Bull World Health Organ. 2008 Sep;86(9):703-9. doi: 10.2471/blt.07.046995.
- De Leo D, Dello Buono M, Dwyer J. Suicide among the elderly: the long-term impact of a telephone support and assessment intervention in northern Italy. Br J Psychiatry. 2002 Sep;181:226-9. doi: 10.1192/bjp.181.3.226.
- Cedereke M, Monti K, Ojehagen A. Telephone contact with patients in the year after a suicide attempt: does it affect treatment attendance and outcome? A randomised controlled study. Eur Psychiatry. 2002 Apr;17(2):82-91. doi: 10.1016/s0924-9338(02)00632-6.
- Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5. doi: 10.1136/bmj.332.7552.1241.
- Gray GC, Chesbrough KB, Ryan MA, Amoroso P, Boyko EJ, Gackstetter GD, Hooper TI, Riddle JR; Millennium Cohort Study Group. The millennium Cohort Study: a 21-year prospective cohort study of 140,000 military personnel. Mil Med. 2002 Jun;167(6):483-8.
- Linehan MM, Comtois K. (1996). Lifetime Parasuicide History. University of Washington, Seattle, WA. Unpublished work.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Rudd MD. The prevalence of suicidal ideation among college students. Suicide Life Threat Behav. 1989 Summer;19(2):173-83. doi: 10.1111/j.1943-278x.1989.tb01031.x.
- Luxton DD, Rudd MD, Reger MA, Gahm GA. A psychometric study of the Suicide Ideation Scale. Arch Suicide Res. 2011;15(3):250-8. doi: 10.1080/13811118.2011.589720.
- Van Orden KA, Witte TK, Gordon KH, Bender TW, Joiner TE Jr. Suicidal desire and the capability for suicide: tests of the interpersonal-psychological theory of suicidal behavior among adults. J Consult Clin Psychol. 2008 Feb;76(1):72-83. doi: 10.1037/0022-006X.76.1.72.
- Joiner, TE. Why People Die by Suicide. Cambridge, MA: Harvard University Press; 2005.
- Luxton DD, Kinn JT, June JD, Pierre LW, Reger MA, Gahm GA. Caring Letters Project: a military suicide-prevention pilot program. Crisis. 2012 Jan 1;33(1):5-12. doi: 10.1027/0227-5910/a000093.
- Luxton DD, June JD, Comtois KA. Can postdischarge follow-up contacts prevent suicide and suicidal behavior? A review of the evidence. Crisis. 2013 Jan 1;34(1):32-41. doi: 10.1027/0227-5910/a000158.
- Motto JA. Suicide prevention for high-risk persons who refuse treatment. Suicide Life Threat Behav. 1976 Winter;6(4):223-30.
- Mahon MJ, Tobin JP, Cusack DA, Kelleher C, Malone KM. Suicide among regular-duty military personnel: a retrospective case-control study of occupation-specific risk factors for workplace suicide. Am J Psychiatry. 2005 Sep;162(9):1688-96. doi: 10.1176/appi.ajp.162.9.1688.
- Kang HK, Bullman TA. Is there an epidemic of suicides among current and former U.S. military personnel? Ann Epidemiol. 2009 Oct;19(10):757-60. doi: 10.1016/j.annepidem.2009.05.004. Epub 2009 Jul 22. No abstract available.
- Chun S, Lee Y. The experience of posttraumatic growth for people with spinal cord injury. Qual Health Res. 2008 Jul;18(7):877-90. doi: 10.1177/1049732308318028.
- Kaplan MS, Huguet N, McFarland BH, Newsom JT. Suicide among male veterans: a prospective population-based study. J Epidemiol Community Health. 2007 Jul;61(7):619-24. doi: 10.1136/jech.2006.054346. Erratum In: J Epidemiol Community Health. 2007 Aug;61(8):751.
- Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.
- Comtois KA, Linehan MM. Psychosocial treatments of suicidal behaviors: a practice-friendly review. J Clin Psychol. 2006 Feb;62(2):161-70. doi: 10.1002/jclp.20220.
- Wright KM, Cabrera OA, Bliese PD, Adler AB, Hoge CW, & Castro CA. Stigma and barriers to care in soldiers postcombat. Psychological Services 2009; 6, 108-116.
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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