Overview

This trial is active, not recruiting.

Conditions suicide, suicide, attempted
Treatment caring letter (email)
Sponsor National Center for Telehealth and Technology
Collaborator United States Department of Defense
Start date November 2011
End date July 2017
Trial size 4730 participants
Trial identifier NCT01473771, MOMRP, W81XWH-11-2-0123

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(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.
caring letter (email) 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.
(No Intervention)
The participants in the Usual Care (UC) group will not receive the emails.

Primary Outcomes

Measure
Suicide Mortality Rates
time frame: Study Completion (2 years)

Secondary Outcomes

Measure
Patient Health Questionnaire (PHQ-9)
time frame: Baseline
Suicide Ideation Scale (SIS)
time frame: Baseline
Interpersonal Needs Questionnaire (INQ)
time frame: Baseline
Acquired Capability for Suicide Scale (ACSS)
time frame: Baseline
Patient Satisfaction Survey
time frame: Baseline
Time to Suicidal Behavior
time frame: Study Completion (2 years)
Medically Admitted Self-Inflicted Injuries
time frame: Study Completion (2 years)
Patient Health Questionnaire (PHQ-9)
time frame: Study Completion (2 years)
Suicide Ideation Scale (SIS)
time frame: Study Completion (2 years)
Interpersonal Needs Questionnaire (INQ)
time frame: Study Completion (2 years)
Acquired Capability for Suicide Scale (ACSS)
time frame: Study Completion (2 years)
Patient Satisfaction Survey
time frame: Study Completion (2 Years)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
Principal investigator David D Luxton, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by National Center for Telehealth and Technology.