Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury

The University of Texas System (UT)

Status: Begins enrollment in 9 months

Conditions: Suicide Risk Factor; Suicide Risk; Suicide Prevention; Mild Traumatic Brain Injury; Suicide Risk | Patient

Treatments: Behavioral: Crisis Response Planning

Study type: Interventional

Funder types: Other

Identifiers

NCT07327567

STUDY00001922

HT94252410714 (Other Grant/Funding Number)

Details and patient eligibility

About

The study purpose is to test the effect of Crisis Response Planning (CRP) when used as the second method of suicide prevention in military service members who are at risk for suicide due to mild traumatic brain injury (mTBI). CRP will be compared to usual treatment. The treatment will be a 30 to 60 minute session to one person at a time either in-person or using telehealth.

Full description

The objective of this randomized clinical trial is to evaluate the efficacy of Crisis Response Planning as a secondary suicide prevention intervention among military service members who are at elevated risk for suicide due to their history of a mild traumatic brain injury (mTBI). CRP will be compared to a general review of available crisis resources facilitated by a therapist.

Specific Aims:

Aim 1: Determine the effectiveness of Crisis Response Planning (CRP) versus Treatment as Usual (TAU) on impulsivity and cognitive-affective states among military personnel with a diagnosis of mTBI.

Aim 2: Understand associations between impulsivity and cognitive-affective states among military personnel with a diagnosis of mTBI.

Aim 3: Determine if mTBI features (e.g., loss of consciousness duration, total number of lifetime TBIs, injury type) influence treatment outcomes.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult male and female active duty military service members aged 18 or older.
• Diagnosis of at least one mTBI
• Ability to read, write, and speak English
• Owns and regularly uses an Apple iPhone or Android smartphone

Exclusion criteria

• Active psychosis as determined by clinical assessment.
• Moderate or greater cognitive impairment as indicated by evaluation by the Intrepid Spirit Center clinical team.
• Completed a Crisis Response Plan within the past year.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Arm 1: Crisis Response Planning (CRP)

Experimental group

Description:

One 30-60-minute session delivered individually using in-person or telehealth format by a trained behavioral health provider.

Treatment:

Behavioral: Crisis Response Planning

Arm 2: Treatment as Usual (TAU)

No Intervention group

Description:

Participants will receive the standard of care treatment as usual (TAU) from the Intrepid Spirit Center interdisciplinary treatment team that includes nurse practitioners, social workers, neurologists, and psychologists.