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SuicideNCT01473771

Caring Letters for Military Suicide Prevention

A study testing Caring Letter (email) in people with Suicide and Suicide, Attempted, run by National Center for Telehealth and Technology at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide, Suicide, Attempted
What is being tested?
Caring Letter (email)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,319 participants
Where
6 sitesin 2 countries
Study dates
Nov 2011to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • VA Western New York, Buffalo VA Medical Center

    Buffalo, New York, 14215

  • Tripler Army Medical Center (TAMC)

    Honolulu, Hawaii, 96859

  • Palo Alto VAHCS

    Palo Alto, California, 94304

  • Naval Medical Center San Diego (NMCSD)

    San Diego, California, 92134

  • National Center for Telehealth and Technology

    Tacoma, Washington, 98431

Other trials in United States

Germany1 site

  • Landstuhl Regional Medical Center

    Landstuhl, 09180

Other trials in Germany

About this study

Official title: 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.

Read more

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.

Read the detailed 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.

Being tested
Caring Letter (email)
Keywords
Suicide, Suicide, Attempted
Medical subject headings
Suicide, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caring Letter (email)Behavioural

    Also called CLP

    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.

Study groups in NCT01473771
Study groupRoleWhat they receive
Caring Letter Condition (CL)ExperimentalIn 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.
Receives: Behavioral: Caring Letter (email)
Usual Care (UC)No interventionThe participants in the Usual Care (UC) group will not receive the emails.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Study Completion (2 years)

Secondary outcomes (1)

  1. Time to Suicidal Behavior

    This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utilization over the previous two years.

    Measured: Study Completion (2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01473771
Sponsor's protocol ID
W81XWH-11-2-0123
Other IDs
MOMRP
Status last verified
Aug 2018
First submitted
14 Nov 2011
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 16183654

  • 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.

    PubMed 18797646

  • 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.

    PubMed 12204927

  • 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.

    PubMed 11973116

  • 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.

    PubMed 16735333

  • 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.

    PubMed 12099084

  • 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.

    PubMed 11556941

  • 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.

    PubMed 2749860

  • 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.

    PubMed 21827314

  • 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.

    PubMed 18229985

Questions about this trial

What is this clinical trial studying?

A study testing Caring Letter (email) in people with Suicide and Suicide, Attempted, run by National Center for Telehealth and Technology at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicide Mortality Rates (time frame: Study Completion (2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01473771, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.

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