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Military Continuity Project (MCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829620
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
Military Suicide Research Consortium
United States Department of Defense
Information provided by (Responsible Party):
Kate Comtois, 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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Active Suicidal and Self-injurious Behavior Behavioral: TAU Behavioral: CCVT+TAU Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Military Continuity Project (MCP): A Suicide Prevention Study
Actual Study Start Date : April 2013
Actual Primary Completion Date : September 19, 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Suicide Attempt Self-Injury Count (SASI-Count) [ Time Frame: 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.

  2. Scale for Suicide Ideation - Worst (SSI-W) [ Time Frame: 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.

  3. Interpersonal Needs Questionnaire (INQ) [ Time Frame: 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.

  4. 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). Secondary outcomes measured by the THI-M include outpatient behavioral health treatments received by participants and emergency department visits.

  5. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 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.


Other Outcome Measures:
  1. Demographic Data Schedule (DDS) [ Time Frame: Baseline ]
    The DDS obtains a wide range of demographic data.

  2. Mobile Phone Use Questionnaire [ Time Frame: 12 months ]
    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.

  3. Military Suicide Research Consortium Common Data Elements (MRSC CDE) [ Time Frame: 12 months ]
    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.

  4. Text Message Reception Survey [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829620


Locations
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United States, California
Marine Corps Air Ground Combat Center Twentynine Palms
Twentynine Palms, California, United States, 92278
United States, North Carolina
Marine Corps Base Camp Lejeune
Camp Lejeune, North Carolina, United States, 28542
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28307
Sponsors and Collaborators
University of Washington
Military Suicide Research Consortium
United States Department of Defense
Investigators
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Principal Investigator: Katherine Anne Comtois, PhD, MPH University of Washington
Principal Investigator: Richard K Ries, MD University of Washington
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kate Comtois, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01829620    
Other Study ID Numbers: STUDY00001901
W81XWH1020181/089009520027450 ( Other Grant/Funding Number: Department of Defense/Florida State University )
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kate Comtois, University of Washington:
suicide
suicide intervention
suicide prevention
military
military suicide
caring letters
caring contacts
text messages
Additional relevant MeSH terms:
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Suicidal Ideation
Self-Injurious Behavior
Suicide
Behavioral Symptoms