Military Continuity Project (MCP)
Primary Purpose
Suicidal Ideation Active, Suicidal and Self-injurious Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAU
CCVT+TAU
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation Active focused on measuring suicide, suicide intervention, suicide prevention, military, military suicide, caring letters, caring contacts, text messages
Eligibility 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
Sites / Locations
- Marine Corps Air Ground Combat Center Twentynine Palms
- Marine Corps Base Camp Lejeune
- Womack Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as Usual (TAU)
Continuing Contacts via Text (CCVT)+TAU
Arm Description
The Treatment as Usual (TAU) control group will reflect current clinical practices for treating suicidal Soldiers and Marines.
The intervention group will receive Continuing Contacts via Text (CCVT) in addition to Treatment as Usual (TAU).
Outcomes
Primary Outcome Measures
Scale for Suicide Ideation - Current (SSI-C)
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)
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
Suicide Attempt Self-Injury Count (SASI-Count)
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.
Scale for Suicide Ideation - Worst (SSI-W)
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.
Interpersonal Needs Questionnaire (INQ)
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)
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.
Client Satisfaction Questionnaire (CSQ)
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.
Full Information
NCT ID
NCT01829620
First Posted
March 30, 2013
Last Updated
June 30, 2020
Sponsor
University of Washington
Collaborators
Military Suicide Research Consortium, United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01829620
Brief Title
Military Continuity Project
Acronym
MCP
Official Title
Military Continuity Project (MCP): A Suicide Prevention Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
September 19, 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Military Suicide Research Consortium, United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation Active, Suicidal and Self-injurious Behavior
Keywords
suicide, suicide intervention, suicide prevention, military, military suicide, caring letters, caring contacts, text messages
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
658 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
The Treatment as Usual (TAU) control group will reflect current clinical practices for treating suicidal Soldiers and Marines.
Arm Title
Continuing Contacts via Text (CCVT)+TAU
Arm Type
Experimental
Arm Description
The intervention group will receive Continuing Contacts via Text (CCVT) in addition to Treatment as Usual (TAU).
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
This is standard outpatient mental health care that is routinely provided in study site outpatient clinics.
Intervention Type
Behavioral
Intervention Name(s)
CCVT+TAU
Intervention Description
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 Measure Information:
Title
Scale for Suicide Ideation - Current (SSI-C)
Description
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.
Time Frame
12 months
Title
Treatment History Interview (THI)
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Suicide Attempt Self-Injury Count (SASI-Count)
Description
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.
Time Frame
12 months
Title
Scale for Suicide Ideation - Worst (SSI-W)
Description
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.
Time Frame
12 months
Title
Interpersonal Needs Questionnaire (INQ)
Description
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.
Time Frame
12 months
Title
Treatment History Interview (THI)
Description
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.
Time Frame
12 months
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Demographic Data Schedule (DDS)
Description
The DDS obtains a wide range of demographic data.
Time Frame
Baseline
Title
Mobile Phone Use Questionnaire
Description
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.
Time Frame
12 months
Title
Military Suicide Research Consortium Common Data Elements (MRSC CDE)
Description
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.
Time Frame
12 months
Title
Text Message Reception Survey
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Anne Comtois, PhD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard K Ries, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marine Corps Air Ground Combat Center Twentynine Palms
City
Twentynine Palms
State/Province
California
ZIP/Postal Code
92278
Country
United States
Facility Name
Marine Corps Base Camp Lejeune
City
Camp Lejeune
State/Province
North Carolina
ZIP/Postal Code
28542
Country
United States
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28307
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11376235
Citation
Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.
Results Reference
background
PubMed Identifier
1023455
Citation
Motto JA. Suicide prevention for high-risk persons who refuse treatment. Suicide Life Threat Behav. 1976 Winter;6(4):223-30.
Results Reference
background
PubMed Identifier
21940244
Citation
Luxton DD, Kinn JT, June JD, Pierre LW, Reger MA, Gahm GA. Caring Letters Project: a military suicide-prevention pilot program. Crisis. 2012 Jan 1;33(1):5-12. doi: 10.1027/0227-5910/a000093.
Results Reference
background
PubMed Identifier
30758491
Citation
Comtois KA, Kerbrat AH, DeCou CR, Atkins DC, Majeres JJ, Baker JC, Ries RK. Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial. JAMA Psychiatry. 2019 May 1;76(5):474-483. doi: 10.1001/jamapsychiatry.2018.4530.
Results Reference
derived
Learn more about this trial
Military Continuity Project
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