Recruiting

Insomnia Treatment

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06551987

Conditions

Insomnia

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Brief Behavioral Therapy for Insomnia

Study Details

Brief summary:

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).

Conditions

Insomnia

Mild Traumatic Brain Injury

Study ID

NCT06551987

Start date

Dec 3, 2024

Status verified date

Dec, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cognitive Behavioral Therapy for Insomnia

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

active comparator: Brief Behavioral Therapy for Insomnia

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

Interventions

Cognitive Behavioral Therapy for Insomnia

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

Brief Behavioral Therapy for Insomnia

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

Primary outcome measure

  • Insomnia Severity Index (ISI) [ Time Frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up ]
  • Neurobehavioral Symptom Inventory (NSI) [ Time Frame: Baseline, 7 Week Follow-up, 12 Week Follow-up ]
  • NIH Toolbox v3 [ Time Frame: Baseline, 7 Week Follow-up ]

Central Contacts and Locations

Central contacts

Isabella McElwain, B.S.

254-226-6987Isabella.l.mcelwain.ctr@health.mil

Kristi E. Pruiksma, Ph.D.

210 562 6700pruiksma@uthscsa.edu

Locations

Carl R. Darnall Army Medical Center

Recruiting

Fort Cavazos, Texas, United States, 76544

Contacts

Scot D Engel, PsyD

(254) 287-7281

Kristi E Pruiksma, PhD

(210) 562-6700pruiksma@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jan 7, 2026

Last verified

Dec, 2025

Keywords

  • Cognitive Behavioral Therapy for Insomnia
  • Brief Behavioral Therapy for Insomnia
  • Insomnia
  • Mild Traumatic Brain Injury
  • Active Duty Military Personnel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-01-07.