Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

The University of Texas System (UT)

Status: Enrolling

Conditions: Insomnia; Mild Traumatic Brain Injury

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Brief Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06551987

STUDY00000222

TP220139 (Other Identifier)

Details and patient eligibility

About

This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).

Full description

The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive symptoms following Mild Traumatic Brain Injury (mTBI). The study will compare Cognitive Behavioral Therapy for Insomnia (CBT-I) and Brief Behavioral Therapy for Insomnia (BBT-I) and determine the impact of behavioral insomnia treatment on insomnia symptom severity. This study will explore the impact of insomnia treatment on prolonged postconcussive symptoms and blood-based biomarkers. The overall objective is to determine if behavioral insomnia therapy can improve outcomes in service members with prolonged postconcussive symptoms following mTBI.

Both in-person and telehealth treatment formats will be offered to adapt to the service members schedule. The minimum acceptable number of sessions to the interventions in order to have evaluable data will be 4 sessions for CBT-I and 3 sessions for BBT-I. A participant is considered to have completed the study if he or she has completed the baseline assessment, at least 4 sessions for CBT-I and 3 sessions for BBT-I, and the 7-week and 12-week follow-up assessments.

Participants will be seen and treated at the Intrepid Spirit Center and/or the STRONG STAR offices both part of the Carl R. Darnall Army Medical Center (CRDAMC) located on the Fort Cavazos. Active duty service members at least 18 years of age who are seeking clinical care for persisting mTBI symptoms at the Intrepid Spirit Center located on Fort Cavazos. Women will be actively recruited into the study.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active duty U.S. military service members.
• At least 18 years of age.
• Ability to provide informed consent and follow study-related instructions.
• Self-report of a Mild Traumatic Brain Injury (mTBI) at least 3 months prior to enrollment based on self-report.
• At least 2 postconcussive symptoms scored > 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item.
• Clinically significant chronic insomnia disorder assessed by an independent evaluator using the Structured Clinical Interview for Sleep Disorders-Revised (SCISD-R)_No Split Week Self-Assessment of Sleep Survey (SASS-Y).
• Minimum score of 15 on the Insomnia Severity Index (ISI).
• Plans to be in the area for the next 3 months.
• Stable on psychotropic and hypnotic medications for at least 1 month.
• Stable on continuous positive airway pressure therapy if diagnosed with sleep apnea for at least 1 month.

Exclusion criteria

• Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated by self-report or medical record.
• Any sleep, medical, or psychiatric disorder requiring urgent treatment (e.g., suicide risk, substance use, insomnia with occupational impairment in high risk professions; very short sleep duration of less than 4 hours on average; bipolar disorder or psychosis) or that otherwise interferes with the completion of the baseline assessment.
• Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3 times per month.
• Planned major surgery.
• Pregnancy, assessed by self-report and review of medical record.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Cognitive Behavioral Therapy for Insomnia

Active Comparator group

Description:

6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

Brief Behavioral Therapy for Insomnia

Active Comparator group

Description:

4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Treatment:

Behavioral: Brief Behavioral Therapy for Insomnia