Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

NCT06551987 | Recruiting DMC

• 2 other identifiers: STUDY00000222TP220139
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index (ISI)

  The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. Each item on the ISI is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), leading to a total possible score between 0 and 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

  Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up

• Neurobehavioral Symptom Inventory (NSI)

  The NSI is a 22-item self-report measure that assesses postconcussive symptoms and classifies them into vestibular, somatic, cognitive, and affective factors, and indicates symptom severity. Respondents rate the severity of each symptom on a scale from 0 (none) to 4 (very severe). Total scores range between 0-88.

  Baseline, 7 Week Follow-up, 12 Week Follow-up

• NIH Toolbox v3

  The NIH Toolbox Cognition Domain measures several aspects of cognitive functioning, including language, episodic memory, executive function, working memory and processing speed. It is a battery administered and automatically scored on the iPad, assessing cognitive function. Higher scores indicate higher levels of functioning compared nationally. A score around 130 suggest superior ability, around 115 suggest above-average fluid cognitive ability, around 100 is average compared with others nationally, around 85 suggests significantly below-average, 70 or below suggests very low functioning.

  Baseline, 7 Week Follow-up

Secondary Outcomes (8)

• Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

  Baseline, 7 Week Follow-up, 12 Week Follow-up

• Nightmare Disorder Index (NDI)

  Baseline, 7 Week Follow-up, 12 Week Follow-up

• Epworth Sleepiness Scale (ESS)

  Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up

• Patient Health Questionnaire (PHQ-9)

  Baseline, 7 Week Follow-up, 12 Week Follow-up

• Multidimensional Fatigue Inventory (MFI-20)

  Baseline, 7 Week Follow-up, 12 Week Follow-up

Study Arms (2)

Cognitive Behavioral Therapy for Insomnia

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy for Insomnia

Brief Behavioral Therapy for Insomnia

ACTIVE COMPARATOR

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

Behavioral: Brief Behavioral Therapy for Insomnia

Interventions

Brief Behavioral Therapy for Insomnia BEHAVIORAL

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

Brief Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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

Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs: collaborator
• Hope Health Research Institute: collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Carl R. Darnall Army Medical Center

Fort Cavazos, Texas, 76544, United States

RECRUITING

Related Publications (3)

• Bramoweth AD, Lederer LG, Youk AO, Germain A, Chinman MJ. Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Behav Ther. 2020 Jul;51(4):535-547. doi: 10.1016/j.beth.2020.02.002. Epub 2020 Feb 20.

  PMID: 32586428 BACKGROUND

• Pruiksma KE, Hale WJ, Mintz J, Peterson AL, Young-McCaughan S, Wilkerson A, Nicholson K, Dondanville KA, Fina BA, Borah EV, Roache JD, Litz BT, Bryan CJ, Taylor DJ; STRONG STAR Consortium. Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel. Behav Ther. 2020 Jul;51(4):522-534. doi: 10.1016/j.beth.2020.02.001. Epub 2020 Feb 14.

  PMID: 32586427 BACKGROUND

• Mysliwiec V, Martin JL, Ulmer CS, Chowdhuri S, Brock MS, Spevak C, Sall J. The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines. Ann Intern Med. 2020 Mar 3;172(5):325-336. doi: 10.7326/M19-3575. Epub 2020 Feb 18.

  PMID: 32066145 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Concussion

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kristi E Pruiksma, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella McElwain, B.S.

CONTACT

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

Kristi E. Pruiksma, Ph.D.

CONTACT

210 562 6700; pruiksma@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)