Military Continuity Project (MCP)
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|ClinicalTrials.gov Identifier: NCT01829620|
Recruitment Status : Active, not recruiting
First Posted : April 11, 2013
Last Update Posted : October 25, 2016
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 CCTV+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|
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 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 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Military Continuity Project (MCP): A Suicide Prevention Study|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Treatment as Usual (TAU)
The Treatment as Usual (TAU) control group will reflect current clinical practices for treating suicidal Soldiers and Marines.
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).
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.
- 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. It has been found to be a valid and reliable measure of 19 characteristics associated with suicidal ideation and intent.
- Suicide Attempt Self-Injury Count (SASI-Count) [ Time Frame: 12 month ]The SASI-Count 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.
- Interpersonal Needs Questionnaire (INQ) [ Time Frame: Baseline and 12 month ]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.
- Treatment History Interview (THI) [ Time Frame: 12 month ]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 ]The RT-C is a brief interview to determine the primary reasons for ending outpatient treatment and the relative 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 ]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.
- Demographic Data Schedule (DDS) [ Time Frame: Baseline ]The DDS obtains a wide range of demographic data.
- Mobile Phone Use Questionnaire [ Time Frame: 12 month ]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 ]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 ]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.
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
|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|
|Principal Investigator:||Jay E Earles, PsyD||Dwight D. Eisenhower Army Medical Center, Fort Gordon, GA|
|Principal Investigator:||Katherine Anne Comtois, PhD, MPH||University of Washington, Psychiatry and Behavorial Sciences Dept.|
|Principal Investigator:||Michael M McDonell, PhD||University of Washington, Psychiatry and Behavorial Sciences Dept.|
|Principal Investigator:||Richard K Ries, MD||University of Washington, Psychiatry and Behavorial Sciences Dept.|
|Study Director:||David C Atkins, PhD||University of Washington, Dept. of Psychiatry and Behavioral Sciences|
|Principal Investigator:||Justine J Majeres, PsyD||Womack Army Medical Center|