NCT01473771

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

6.8 years

First QC Date

November 14, 2011

Last Update Submit

August 21, 2018

Conditions

Keywords

SuicideSuicide, Attempted

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time to Suicidal Behavior

    Study Completion (2 years)

Study Arms (2)

Caring Letter Condition (CL)

EXPERIMENTAL

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)

Usual Care (UC)

NO INTERVENTION

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

Interventions

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.

Also known as: CLP
Caring Letter Condition (CL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current psychiatric inpatients
  • Possess an active email account
  • Informed consent
  • Active duty military, Veteran, Retiree, National Guard or Reserves status

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Palo Alto VAHCS

Palo Alto, California, 94304, United States

Location

Naval Medical Center San Diego (NMCSD)

San Diego, California, 92134, United States

Location

Tripler Army Medical Center (TAMC)

Honolulu, Hawaii, 96859, United States

Location

VA Western New York, Buffalo VA Medical Center

Buffalo, New York, 14215, United States

Location

National Center for Telehealth and Technology

Tacoma, Washington, 98431, United States

Location

Landstuhl Regional Medical Center

Landstuhl, 09180, Germany

Location

Related Publications (27)

  • 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

    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.

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

    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.

    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.

    PMID: 16183654BACKGROUND
  • 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.

    PMID: 18797646BACKGROUND
  • 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.

    PMID: 12204927BACKGROUND
  • 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.

    PMID: 11973116BACKGROUND
  • 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.

    PMID: 16735333BACKGROUND
  • 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.

    PMID: 12099084BACKGROUND
  • Linehan MM, Comtois K. (1996). Lifetime Parasuicide History. University of Washington, Seattle, WA. Unpublished work.

    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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 2749860BACKGROUND
  • 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.

    PMID: 21827314BACKGROUND
  • 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.

    PMID: 18229985BACKGROUND
  • Joiner, TE. Why People Die by Suicide. Cambridge, MA: Harvard University Press; 2005.

    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.

    PMID: 21940244BACKGROUND
  • 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.

    PMID: 22846445BACKGROUND
  • 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.

  • 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.

    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.

MeSH Terms

Conditions

SuicideSuicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • David D Luxton, PhD

    National Center for Telehealth and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations