Caring Letters for Military Suicide Prevention

Suicide Clinical Trial

Official title:

Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473771
• Other study ID #: W81XWH-11-2-0123
• Secondary ID: MOMRP
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: National Center for Telehealth and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1319
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
Germany	Landstuhl Regional Medical Center	Landstuhl
United States	VA Western New York, Buffalo VA Medical Center	Buffalo	New York
United States	Tripler Army Medical Center (TAMC)	Honolulu	Hawaii
United States	Palo Alto VAHCS	Palo Alto	California
United States	Naval Medical Center San Diego (NMCSD)	San Diego	California
United States	National Center for Telehealth and Technology	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
National Center for Telehealth and Technology	U.S. Army Medical Research and Materiel Command, United States Department of Defense

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (26)

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. Epub 2005 Sep 23. — View Citation

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. — View Citation

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. — View Citation

Comtois KA, Linehan MM. Psychosocial treatments of suicidal behaviors: a practice-friendly review. J Clin Psychol. 2006 Feb;62(2):161-70. Review. — View Citation

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. — View Citation

Fleischmann A, Bertolote JM, Wasserman D, De Leo D, Bolhari J, Botega NJ, De Silva D, Phillips M, Vijayakumar L, Värnik 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. — View Citation

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. — View 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.

Joiner, TE. Why People Die by Suicide. Cambridge, MA: Harvard University Press; 2005.

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. Review. — View Citation

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. Erratum in: J Epidemiol Community Health. 2007 Aug;61(8):751. — View Citation

Karch DL, Dahlberg LL, Patel N, Davis TW, Logan JE, Hill HA, Ortega L; Centers for Disease Control and Prevention (CDC). Surveillance for violent deaths--national violent death reporting system, 16 States, 2006. MMWR Surveill Summ. 2009 Mar 20;58(1):1-44. — View Citation

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. — View Citation

Linehan MM, Comtois K. (1996). Lifetime Parasuicide History. University of Washington, Seattle, WA. Unpublished work.

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. Review. — View Citation

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. — View Citation

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. — View 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.

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. — View Citation

Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. — View Citation

Motto JA. Suicide prevention for high-risk persons who refuse treatment. Suicide Life Threat Behav. 1976 Winter;6(4):223-30. — View 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

Rudd MD. The prevalence of suicidal ideation among college students. Suicide Life Threat Behav. 1989 Summer;19(2):173-83. — View Citation

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. — View Citation

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. — View Citation

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.

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Study Completion (2 years)
Secondary	Time to Suicidal Behavior	This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utilization over the previous two years.	Study Completion (2 years)