Military Continuity Project

Suicidal and Self-injurious Behavior Clinical Trial

— MCP  

Official title:

Military Continuity Project (MCP): A Suicide Prevention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829620
• Other study ID #: STUDY00001901
• Secondary ID: W81XWH1020181/08
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2018

Study information

• Verified date: June 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: April 2018
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicidal and Self-injurious Behavior
• Suicidal Ideation
• Suicidal Ideation Active

Intervention

Behavioral:
• TAU
This is standard outpatient mental health care that is routinely provided in study site outpatient clinics.
• CCVT+TAU
Participants in the CCVT + TAU condition will receive caring texts at 1 day, 1 week, 1, 2, 3, 4, 6, 8, 10, & 12 months, and on their birthday. Text messages will indicate a general concern for the individual and a link to a website with general resources including behavioral health and crisis services. Participants in both conditions will continue to receive usual behavioral health care according to standard operating procedures.

Locations

Country	Name	City	State
United States	Marine Corps Base Camp Lejeune	Camp Lejeune	North Carolina
United States	Womack Army Medical Center	Fort Bragg	North Carolina
United States	Marine Corps Air Ground Combat Center Twentynine Palms	Twentynine Palms	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Military Suicide Research Consortium, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. — View Citation

Motto JA. Suicide prevention for high-risk persons who refuse treatment. Suicide Life Threat Behav. 1976 Winter;6(4):223-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic Data Schedule (DDS)	The DDS obtains a wide range of demographic data.	Baseline
Other	Mobile Phone Use Questionnaire	A series of questions characterizing the Service Member's mobile and texting capacity and history will be included to determine that they are likely to receive the study texts and contextualize the receipt of these texts in terms of their frequency of text, phone, and other technology use.	12 months
Other	Military Suicide Research Consortium Common Data Elements (MRSC CDE)	The MRSC CDE includes items regarding suicidal behavior, behavioral health and traumatic brain injury symptoms, and hopelessness that are to be included in all MRSC-funded studies.	12 months
Other	Text Message Reception Survey	The Text Message Reception Survey is a short questionnaire regarding whether or not the participant received text messages from the study staff, and attitudes about the text messages.	12 months
Primary	Scale for Suicide Ideation - Current (SSI-C)	The SSI-C is an interviewer-administered scale that measures a Service Member's suicidal ideation at its worst point in the past 2 weeks.	12 months
Primary	Treatment History Interview (THI)	The THI captures the subject's treatment history. The investigators have modified a version to more appropriately capture the services Service Members are likely to receive, the Treatment History Interview - Military (THI-M). Primary outcome measured by the THI-M is suicide risk incidents (inpatient admission or medical evacuation to prevent suicide)	12 months
Secondary	Suicide Attempt Self-Injury Count (SASI-Count)	The SASI-Count is an interviewer-administered brief instrument that creates a thumbnail sketch of a participant's history of self-directed violence (SDV) by assessing the first, most recent, and most severe acts of SDV during a specified time period, including the date, method, and suicidal intent of the act. This is followed by an assessment of SDV across 12 methods (e.g., cutting, hanging or strangling, firearm), generating counts by method and then classifying each act by suicidal intent (no, ambivalent, or clear intent). Across each method, the most lethal event is coded on a 1-6 scale in which "1" is "very low" (e.g., head banging) and "6" is "severe" (e.g., pulling the trigger of a loaded gun aimed at a vital area). A "Lifetime" version of the instrument was used at baseline, assessing all lifetime acts of SDV. A "Recent" version assessed SDV in the past year at baseline and at 12-month follow-up.	12 months
Secondary	Scale for Suicide Ideation - Worst (SSI-W)	The SSI-W focused on worst-point ideation lifetime when administered at enrollment. At 12 months, the SSI-W captured worst-point ideation, if any, between baseline and follow-up. The SSI-W was added as an outcome after the first 35 cases completed follow-up upon learning it was becoming a standard in clinical trials using the SSI.	12 months
Secondary	Interpersonal Needs Questionnaire (INQ)	The INQ, developed by Joiner and colleagues, will be used to measure beliefs about the extent to which individuals feel connected to others and feel like a burden on the people in their lives. Change in thwarted belongingness is being tested as a mediator of outcome.	12 months
Secondary	Treatment History Interview (THI)	The THI captures the subject's treatment history. The investigators have modified a version to more appropriately capture the services Service Members are likely to receive, the Treatment History Interview - Military (THI-M). Secondary outcomes measured by the THI-M include outpatient behavioral health treatments received by participants and emergency department visits.	12 months
Secondary	Client Satisfaction Questionnaire (CSQ)	The CSQ is a brief eight-item questionnaire, which is used frequently for evaluating standard community mental health care. The CSQ will help determine if the caring texts improve treatment satisfaction.	12 months