Caring Letters for Military Suicide Prevention

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
National Center for Telehealth and Technology
ClinicalTrials.gov Identifier:
NCT01473771
First received: November 14, 2011
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Suicide
Suicide, Attempted
Behavioral: Caring Letter (email)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by National Center for Telehealth and Technology:

Primary Outcome Measures:
  • Suicide Mortality Rates [ Time Frame: Study Completion (2 years) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The PHQ-9 is the depression scale of the PHQ and consists of nine items that specifically target the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnositc criteria for major depressive disorder.

  • Suicide Ideation Scale (SIS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The 10 item Suicidal Ideation Scale (Rudd) provides critial information about the presence or absence of suicidal thinking, the intensity of those thoughts, and the presence or absence of prior suicide attempts.

  • Interpersonal Needs Questionnaire (INQ) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The 18 item Interpersonal Needs Questionnaire aims to measure the following two constructs: thwarted belongingness and perceived burdensomeness.

  • Acquired Capability for Suicide Scale (ACSS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The 20 item Acquired Capability for Suicide Scale aims to measure the construct of acquired capability for lethal self-injury.

  • Patient Satisfaction Survey [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Patient Satisfaction Survey includes 13 questions regarding satisfaction with the interview process.

  • Time to Suicidal Behavior [ Time Frame: Study Completion (2 years) ] [ Designated as safety issue: No ]
    This is a survey that will assess participant suicidal behaviors and medical/psychiatric treatment utlization over the previous two years.

  • Medically Admitted Self-Inflicted Injuries [ Time Frame: Study Completion (2 years) ] [ Designated as safety issue: No ]
    Suicide behaviors requiring hospital admission will be tracked by verifying patient electronic medical record with time to suicidal event will be longer among participants receiving the Caring Letters intervention compared to the ususal care condition.

  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Study Completion (2 years) ] [ Designated as safety issue: No ]
    The PHQ-9 is the depression scale of the PHQ and consists of nine items that specifically target the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnositc criteria for major depressive disorder.

  • Suicide Ideation Scale (SIS) [ Time Frame: Study Completion (2 years) ] [ Designated as safety issue: No ]
    The 10 item Suicidal Ideation Scale (Rudd) provides critial information about the presence or absence of suicidal thinking, the intensity of those thoughts, and the presence or absence of prior suicide attempts.

  • Interpersonal Needs Questionnaire (INQ) [ Time Frame: Study Completion (2 years) ] [ Designated as safety issue: No ]
    The 18 item Interpersonal Needs Questionnaire aims to measure the following two constructs: thwarted belongingness and perceived burdensomeness.

  • Acquired Capability for Suicide Scale (ACSS) [ Time Frame: Study Completion (2 years) ] [ Designated as safety issue: No ]
    The 20 item Acquired Capability for Suicide Scale aims to measure the construct of acquired capability for lethal self-injury.

  • Patient Satisfaction Survey [ Time Frame: Study Completion (2 Years) ] [ Designated as safety issue: No ]
    The Patient Satisfaction Survey includes 13 questions regarding satisfaction with the interview process.


Estimated Enrollment: 4730
Study Start Date: November 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: CLP
No Intervention: Usual Care (UC)
The participants in the Usual Care (UC) group will not receive the emails.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473771

Locations
United States, California
Palo Alto VAHCS
Palo Alto, California, United States, 94304
Naval Medical Center San Diego (NMCSD)
San Diego, California, United States, 92134
United States, Hawaii
Tripler Army Medical Center (TAMC)
Honolulu, Hawaii, United States, 96859
United States, New York
VA Western New York, Buffalo VA Medical Center
Buffalo, New York, United States, 14215
United States, Washington
National Center for Telehealth and Technology
Tacoma, Washington, United States, 98431
Germany
Landstuhl Regional Medical Center
Landstuhl, Germany, 09180
Sponsors and Collaborators
National Center for Telehealth and Technology
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: David D Luxton, PhD National Center for Telehealth and Technology
  More Information

Publications:
Luxton DD, Kinn JT, June JD, Pierre LW, Reger MA, Gahm GA. (in press). The Caring Letter Project: A Military Suicide Prevention Pilot Program. CRISIS: The Journal of Crisis Intervention and Suicide Prevention.
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.
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.
Luxton, D. D., Kinn, J. T., June, J. D., Pierre, L. W., Reger, M. A., Gahm, G. A., (2011). The Caring Letter Project: A Military Suicide Prevention Pilot Program. Crisis: The Journal of Crisis Intervention and Suicide Prevention, 33, 5-12.

Responsible Party: National Center for Telehealth and Technology
ClinicalTrials.gov Identifier: NCT01473771     History of Changes
Other Study ID Numbers: W81XWH-11-2-0123, MOMRP
Study First Received: November 14, 2011
Last Updated: September 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Center for Telehealth and Technology:
Suicide
Suicide, Attempted

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 31, 2014