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Clinical Trials/NCT01829620
NCT01829620CompletedNot Applicable

Military Continuity Project (MCP): A Suicide Prevention Study

University of Washington3 sites in 1 country658 target enrollmentStarted: April 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
658
Locations
3
Primary Endpoint
Scale for Suicide Ideation - Current (SSI-C)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Continuing Contacts via Text (CCVT)+TAU

Experimental

The intervention group will receive Continuing Contacts via Text (CCVT) in addition to Treatment as Usual (TAU).

Intervention: CCVT+TAU (Behavioral)

Treatment as Usual (TAU)

Active Comparator

The Treatment as Usual (TAU) control group will reflect current clinical practices for treating suicidal Soldiers and Marines.

Intervention: TAU (Behavioral)

Outcomes

Primary Outcomes

Scale for Suicide Ideation - Current (SSI-C)

Time Frame: 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)

Time Frame: 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 Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kate Comtois

Professor

University of Washington

Study Sites (3)

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