Military Continuity Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

658 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations

NCT02042131

Suicide Suicidal Ideation

COMPLETED NA

Caring Letters for Military Suicide Prevention

NCT01473771

Suicide Suicide, Attempted

COMPLETED NA

Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors

NCT06318962

Suicidal Behaviors Suicide Ideation Depression/Anxiety

RECRUITING NA

Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart

NCT01300169

Suicidal Ideation Active Suicidal and Self-injurious Behavior

COMPLETED NA

Comparing Suicide Prevention Interventions to Guide Follow-up Care: The SPRING Trial

NCT06128239

Suicide Suicide Prevention Suicide and Self-harm

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suicidal Ideation Active Suicidal and Self-injurious Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment as Usual (TAU)

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

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type BEHAVIORAL

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

Continuing Contacts via Text (CCVT)+TAU

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

Group Type EXPERIMENTAL

CCVT+TAU

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAU

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No