Caring Letters for Military Suicide Prevention

NCT ID: NCT01473771

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Suicide Suicide, Attempted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Caring Letter (email)

Intervention Type BEHAVIORAL

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.

Usual Care (UC)

The participants in the Usual Care (UC) group will not receive the emails.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CLP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

National Center for Telehealth and Technology

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David D Luxton, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Telehealth and Technology

Locations

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Palo Alto VAHCS

Palo Alto, California, United States

Site Status

Naval Medical Center San Diego (NMCSD)

San Diego, California, United States

Site Status

Tripler Army Medical Center (TAMC)

Honolulu, Hawaii, United States

Site Status

VA Western New York, Buffalo VA Medical Center

Buffalo, New York, United States

Site Status

National Center for Telehealth and Technology

Tacoma, Washington, United States

Site Status

Landstuhl Regional Medical Center

Landstuhl, , Germany

Site Status

Countries

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United States Germany

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

National Violent Death Reporting System: Centers for Disease Control and Prevention; 2009

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16183654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18797646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12204927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11973116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16735333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12099084 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2749860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21827314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18229985 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 21940244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22846445 (View on PubMed)

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

Reference Type RESULT
PMID: 1023455 (View on PubMed)

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.

Reference Type RESULT
PMID: 16135629 (View on PubMed)

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.

Reference Type RESULT
PMID: 19628411 (View on PubMed)

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.

Reference Type RESULT
PMID: 18552315 (View on PubMed)

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.

Reference Type RESULT
PMID: 17568055 (View on PubMed)

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.

Reference Type RESULT
PMID: 11376235 (View on PubMed)

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.

Reference Type RESULT
PMID: 16342292 (View on PubMed)

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.

Reference Type RESULT

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(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

Other Identifiers

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MOMRP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH-11-2-0123

Identifier Type: -

Identifier Source: org_study_id

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