Military Continuity Project (MCP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Washington
Sponsor:
Collaborators:
Military Suicide Research Consortium (MSRC)
Information provided by (Responsible Party):
Kate Comtois, University of Washington
ClinicalTrials.gov Identifier:
NCT01829620
First received: March 30, 2013
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

The investigators propose to utilize text messaging to create and investigate the efficacy of a Continuing Contacts via Text (CCVT) plus Treatment as Usual (TAU) intervention that extends the continuity of care for service members who have engaged in suicidal behavior and/or reported suicidal ideation by sending them regular caring text messages over a 12-month period.

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

  • Hypothesis 1a: Participants assigned to CCTV + TAU compared to TAU alone will experience reduced suicidal ideation at 12-month follow-up.
  • Hypothesis 1b: Over the 12 months post-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 post-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 compared to treatment as usual alone will be mediated by reductions in "thwarted belongingness" from pre to post-study.
  • Hypothesis 2b: The effect of CCVT compared to treatment as usual alone will be mediated by increased use of outpatient behavioral health services in the CCVT condition.

Condition Intervention
Suicidal Ideation Active
Suicidal and Self-injurious Behavior
Behavioral: TAU
Behavioral: CCVT + TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Military Continuity Project (MCP): A Suicide Prevention Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Scale for Suicide Ideation - Current (SSI-C) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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. It has been found to be a valid and reliable measure of 19 characteristics associated with suicidal ideation and intent.


Secondary Outcome Measures:
  • Suicide Attempt Self-Injury Count (SASI-C) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The SASI-C is a brief two-page instrument determining the first, most recent, and most severe suicide attempt or non-suicidal self-injury. It assesses the date, method used, intent to die, highest level of medical treatment received, and lethality.

  • Change in Thawarted Belongingness in the Interpersonal Needs Questionnaire (INQ) [ Time Frame: Baseline and 12 month ] [ Designated as safety issue: No ]
    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. This is being tested as a mediator of outcome.

  • Treatment History Interview (THI) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The THI uses a time-line follow-back method of assessment and will capture 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).

  • Reasons for Termination - Client (RT-C) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The RT-C is a brief interview to determine the primary reasons for ending outpatient treatment and the relevant importance if more than one reason. This will help determine if the caring texts improve treatment acceptability.

  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Demographic Data Schedule (DDS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The DDS obtains a wide range of demographic data.

  • Mobile Phone Use Questionnaire [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.

  • Military Suicide Research Consortium Common Data Elements (MRSC CDE) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The MRSC CDE includes items regarding suicidal behavior, behavioral health and TBI symptoms, and hopelessness that are to be included in all MRSC funded studies.

  • Text Message Reception Survey [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 800
Study Start Date: April 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment as Usual (TAU)
The Treatment as Usual (TAU) control group will reflect current clinical practices for treating suicidal Soldiers and Marines.
Behavioral: TAU
This is standard outpatient mental health care that is routinely provided in study site outpatient clinics.
Experimental: Continuing Contacts via Text (CCVT) +TAU
The intervention group will receive Continuing Contacts via Text (CCVT) in addition to Treatment as Usual (TAU).
Behavioral: 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.


Detailed Description:

Apparent increases in suicidal behaviors and death by suicide among active duty service members have gained considerable attention from the media, members of Congress, and the DoD. 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 behavior and initial pilot data have shown positive results in military populations.

Text messaging is 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 to 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) due to suicidal behavior - either 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 they do 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829620

Contacts
Contact: Katherine Anne Comtois, PhD, MPH 206-897-4225 comtois@uw.edu
Contact: Amanda Kerbrat, MSW 206-744-1716 ahm2@uw.edu

Locations
United States, California
Marine Corps Air Ground Combat Center Twentynine Palms Recruiting
Twentynine Palms, California, United States, 92278
United States, North Carolina
Marine Corps Base Camp Lejeune Not yet recruiting
Camp Lejeune, North Carolina, United States, 28542
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28307
Sponsors and Collaborators
University of Washington
Military Suicide Research Consortium (MSRC)
Investigators
Principal Investigator: Jay Earles, PsyD Womack Army Medical Center Dept. of Behavorial Health
Principal Investigator: Katherine A Comtois, PhD, MPH University of Washington, Psychiatry and Behavorial Sciences Dept.
Principal Investigator: Michael McDonell, PhD University of Washington, Psychiatry and Behavorial Sciences Dept.
Principal Investigator: Richard Ries, MD University of Washington, Psychiatry and Behavorial Sciences Dept.
Study Director: David Atkins, PhD University of Washington, Dept. of Psychiatry and Behavioral Sciences
  More Information

Publications:
Responsible Party: Kate Comtois, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01829620     History of Changes
Other Study ID Numbers: R01477, W81XWH1020181/089009520027450
Study First Received: March 30, 2013
Last Updated: April 8, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of Washington:
suicide
suicide intervention
suicide prevention
military
military suicide
caring letters
caring contacts
text messages

Additional relevant MeSH terms:
Self-Injurious Behavior
Suicidal Ideation
Behavioral Symptoms
Suicide

ClinicalTrials.gov processed this record on August 28, 2014