Military Continuity Project

NCT01829620 | Completed DMC

• 2 other identifiers: STUDY00001901W81XWH1020181/089009520027450
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 3

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.

Conditions

Suicidal Ideation Active; Suicidal and Self-injurious Behavior

Keywords

suicide; suicide intervention; suicide prevention; military; military suicide; caring letters; caring contacts; text messages

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• 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)

  12 months

Secondary Outcomes (5)

• Suicide Attempt Self-Injury Count (SASI-Count)

  12 months

• Scale for Suicide Ideation - Worst (SSI-W)

  12 months

• Interpersonal Needs Questionnaire (INQ)

  12 months

• Treatment History Interview (THI)

  12 months

• Client Satisfaction Questionnaire (CSQ)

  12 months

Other Outcomes (4)

• Demographic Data Schedule (DDS)

  Baseline

• Mobile Phone Use Questionnaire

  12 months

• Military Suicide Research Consortium Common Data Elements (MRSC CDE)

  12 months

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: TAU

Continuing Contacts via Text (CCVT)+TAU

EXPERIMENTAL

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

Behavioral: CCVT+TAU

Interventions

TAU BEHAVIORAL

This is standard outpatient mental health care that is routinely provided in study site outpatient clinics.

Treatment as Usual (TAU)

CCVT+TAU BEHAVIORAL

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.

Continuing Contacts via Text (CCVT)+TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty, Reserve, National Guard
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Military Suicide Research Consortium: collaborator
• United States Department of Defense: collaborator

Study Sites (3)

Marine Corps Air Ground Combat Center Twentynine Palms

Twentynine Palms, California, 92278, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28307, United States

Location

Marine Corps Base Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, 28542, United States

Location

Related Publications (4)

• 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.

  PMID: 11376235 BACKGROUND

• Motto JA. Suicide prevention for high-risk persons who refuse treatment. Suicide Life Threat Behav. 1976 Winter;6(4):223-30.

  PMID: 1023455 BACKGROUND

• 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.

  PMID: 21940244 BACKGROUND

• 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.

  PMID: 30758491 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide; Suicide Prevention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Katherine Anne Comtois, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Richard K Ries, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2013
• First Posted: April 11, 2013
• Study Start: April 1, 2013
• Primary Completion: September 19, 2017
• Study Completion: April 1, 2018
• Last Updated: July 2, 2020

Record last verified: 2020-06

Locations

US (3)