Clinical trial NCT01829620: Military Continuity Project
Official title: Military Continuity Project (MCP): A Suicide Prevention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation Active
Suicidal and Self-injurious Behavior
Keywords: suicide
suicide intervention
suicide prevention
military
military suicide
caring letters
caring contacts
text messages
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Military Suicide Research Consortium
name: United States Department of Defense
First posted: 2013-04-11
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to utilize text messaging to create and investigate the efficacy of a Continuing Contacts via Text (CCVT) intervention that extends the continuity of care for Service Members with a recent suicide attempt and/or reported suicidal ideation by sending them non-demanding caring text messages at regular intervals over a 12-month period. Participants will be randomly assigned to receive Continuing Contacts via Text (CCVT) in addition to Treatment as Usual (TAU) or TAU alone.

Aim 1: To determine if the addition of 12 months of CCVT to TAU (CCVT+TAU) results in lower rates of suicidal ideation and behavior relative to TAU alone.

* Hypothesis 1a: Participants assigned to CCVT+TAU compared to TAU alone will experience reduced suicidal ideation at 12-month follow-up.
* Hypothesis 1b: Over the 12 months following study enrollment, a smaller proportion of participants assigned to CCVT+TAU vs. TAU alone will have suicide risk incidents (i.e., those requiring medical evacuation or hospital admission).
* Hypothesis 1c: Over the 12 months following study enrollment, CCVT+TAU vs. TAU alone will have fewer total number of suicide risk incidents requiring medical evacuation or hospital admission.

Aim 2: To test two proposed mechanisms of action of CCVT outcome: 1) reduced "thwarted belongingness" and 2) increased engagement in behavioral health services.

* Hypothesis 2a: The effect of CCVT+TAU compared to TAU alone will be mediated by reductions in "thwarted belongingness" from pre to post-study.
* Hypothesis 2b: The effect of CCVT+TAU compared to TAU alone will be mediated by increased use of outpatient behavioral health services in the CCVT+TAU condition.

Detailed description: Apparent increases in suicide attempts and death by suicide among active duty Service Members have gained considerable attention from the media, members of Congress, and the Department of Defense. Identifying and intervening with individuals thinking of suicide (as well as those engaging in suicidal behavior) is key to preventing suicide in Service Members. Intervention through caring contacts (e.g., letters, phone calls) have efficacy showing they may be an important adjunct or alternative to outpatient care. Caring contact interventions have been shown in previous studies to decrease suicidal ideation and attempts and initial pilot data have shown positive results in military populations.

Text messaging, a low-cost means of sending brief messages (160 characters) to any owner of a mobile phone, has been investigated as an intervention for improving attendance to medical appointments and adherence to treatment in medical populations. As our current military population is a young, mobile, and increasingly technologically savvy population, and with the growing support behind text messaging as a feasible and effective mode of behavioral intervention, the pairing of text messaging and caring contact interventions warrants further research.

The investigators plan to randomize 800 participating Service Members to one of the two treatment conditions (i.e., CCVT+TAU or TAU alone) to test the efficacy of this intervention. Measured endpoints will include suicide risk incident requiring medical evacuation or hospitalization, suicidal ideation as identified by the follow-up assessment battery, "thwarted belongingness" as identified by The Interpersonal Needs Questionnaire, outpatient behavioral health care utilization, and death.

Eligibility criteria: INCLUSION CRITERIA:

* Active duty, Reserve, National Guard
* 18 or more years of age
* Identification to a behavioral health, counseling, or medical service (inpatient, outpatient, or emergency) with suicidal ideation or a suicide attempt
* Has current suicidal ideation as defined by the Scale for Suicidal Ideation-Current (SSI-C)
* Has mobile phone or pager where he or she can receive 11 text messages in a year free of cost or at a fee he or she does not consider burdensome

EXCLUSION CRITERIA:

* Does not speak and read English well enough to consent and to understand texts in English
* Too cognitively impaired at best mental status during treatment to consent to participate (i.e., brain damage, psychosis, dementia, or other cause)
* Treating clinician evaluates the intervention as contra-indicated (e.g., paranoia exacerbated by being contacted)
* Prisoner or otherwise under judicial order where study participation could not be considered to be truly voluntary

Primary outcomes:
measure: Scale for Suicide Ideation - Current (SSI-C)
timeFrame: 12 months
measure: Treatment History Interview (THI)
timeFrame: 12 months
Secondary outcomes:
measure: Suicide Attempt Self-Injury Count (SASI-Count)
timeFrame: 12 months
measure: Scale for Suicide Ideation - Worst (SSI-W)
timeFrame: 12 months
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: 12 months
measure: Treatment History Interview (THI)
timeFrame: 12 months
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 12 months
Other outcomes:
measure: Demographic Data Schedule (DDS)
timeFrame: Baseline
measure: Mobile Phone Use Questionnaire
timeFrame: 12 months
measure: Military Suicide Research Consortium Common Data Elements (MRSC CDE)
timeFrame: 12 months
measure: Text Message Reception Survey
timeFrame: 12 months
Locations:
city: Twentynine Palms
country: United States
facility: Marine Corps Air Ground Combat Center Twentynine Palms
state: California
city: Camp Lejeune
country: United States
facility: Marine Corps Base Camp Lejeune
state: North Carolina
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: University of Washington
name: Katherine Anne Comtois, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Richard K Ries, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Motto JA. Suicide prevention for high-risk persons who refuse treatment. Suicide Life Threat Behav. 1976 Winter;6(4):223-30.
citation: 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.
citation: Comtois KA, Kerbrat AH, DeCou CR, Atkins DC, Majeres JJ, Baker JC, Ries RK. Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial. JAMA Psychiatry. 2019 May 1;76(5):474-483. doi: 10.1001/jamapsychiatry.2018.4530.