Military Continuity Project

Not Applicable

Completed

• Conditions: Suicidal and Self-injurious Behavior; Suicidal Ideation Active
• Interventions: Behavioral: TAU; Behavioral: CCVT+TAU

• Registration Number: NCT01829620
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2013-03-30
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-11
• Primary Completion: 2017-09-19
• Study Completion: 2018-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual (TAU)	TAU	The Treatment as Usual (TAU) control group will reflect current clinical practices for treating suicidal Soldiers and Marines.
Continuing Contacts via Text (CCVT)+TAU	CCVT+TAU	The intervention group will receive Continuing Contacts via Text (CCVT) in addition to Treatment as Usual (TAU).

Primary Outcome Measures

Name	Time	Method
Scale for Suicide Ideation - Current (SSI-C)	12 months	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.
Treatment History Interview (THI)	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Suicide Attempt Self-Injury Count (SASI-Count)	12 months	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.
Interpersonal Needs Questionnaire (INQ)	12 months	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.
Client Satisfaction Questionnaire (CSQ)	12 months	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.
Scale for Suicide Ideation - Worst (SSI-W)	12 months	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.
Treatment History Interview (THI)	12 months	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.

Trial Locations

Locations (3)

Marine Corps Air Ground Combat Center Twentynine Palms; 🇺🇸 Twentynine Palms, California, United States

Marine Corps Base Camp Lejeune; 🇺🇸 Camp Lejeune, North Carolina, United States

Womack Army Medical Center; 🇺🇸 Fort Bragg, North Carolina, United States