Recruiting

CBT-I

Sponsor:

University of Missouri-Columbia

Code:

NCT07385105

Conditions

Sleep Architecture

Mild Traumatic Brain Injury

Sleep

Sleep and Circadian Problems

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Cognitive behavioral Therapy for insomnia (CBT-I)

Study Details

Brief summary:

This study will employ cognitive behavioral therapy for insomnia (CBT-I) among individuals with mild traumatic brain injury (mTBI) who experience sleep disturbances. The research aims to evaluate the effects of CBT-I on sleep, mTBI symptoms, and, in particular, the ability of individuals with mTBI to engage in their desired daily life activities. The main questions this study aims to answer are:

1. Does CBT-I positively impact symptoms of mTBI?
2. Does CBT-I improve functional performance in individuals with mTBI?

Conditions

Sleep Architecture

Mild Traumatic Brain Injury

Sleep

Sleep and Circadian Problems

Study ID

NCT07385105

Start date

Mar 1, 2026

Status verified date

Feb, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A history of mTBI documented by a physician and sleep problems for more than 4 weeks
  • A score ≥ 10 on the Insomnia Severity Index (ISI)
  • Speak, read, and write English

Exclusion Criteria:

  • History of other neurological or psychological conditions
  • Patient Health Questionnaire-9 (PHQ-9) score higher than 20 (severe depressive symptoms)
  • Generalized Anxiety Disorder-7 (GAD-7) score higher than 15 (severe anxiety symptoms)
  • Montreal Cognitive Assessment (MoCA) score less than 24

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 15 mTBI cases who have sleep problems will receive CBT-I

We will achieve the study's aims with a single-group, pre-post design (n=15). Participants with physician-diagnosed mild traumatic brain injury who are experiencing sleep problems for more than four weeks will receive cognitive behavioral therapy for insomnia (CBT-I). Participants will engage in six one-hour, weekly CBT-I sessions delivered in a one-on-one format through the Zoom Video Conference. Participants will establish sleep-related goals. During the intervention session, the interventionist will address the cognitive and behavioral components of CBT-I, as well as relaxation techniques and sleep hygiene.

Interventions

Cognitive behavioral Therapy for insomnia (CBT-I)

CBT-I is an evidence-based psychotherapy designed to address insomnia. This structured and multifaceted intervention aims to help individuals who have trouble falling asleep or/ and staying asleep during the night. CBT-I is a multi-component treatment that includes two core parts: behavioral and cognitive aspects. It consists of Sleep Restriction Therapy (SRT), Stimulus Control Therapy (SCT), and Cognitive Therapy (CT) with an emphasis on Cognitive restructuring, as well as Psychoeducation and Sleep Hygiene Education. Each CBT-I session has a clear structure and includes various components such as assessment, psychoeducation, behavioral and cognitive interventions, adherence monitoring, and strategies for preventing relapse. In this study, participants will receive CBT-I in a one-on-one setting, meeting on Zoom once a week for six weeks, and each session will last an hour.

Primary outcome measure

  • The expanded consensus sleep diary (CSD) [ Time Frame: Through study completion, an average of 10 weeks. ]
  • Insomnia Severity Index (ISI) [ Time Frame: Baseline (Day 1) ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline (Day 1) ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline (Day 1) ]
  • Canadian Occupation Performance Measure (COPM) [ Time Frame: Baseline (day 1) ]
  • Activity Card Sort (ACS) [ Time Frame: Baseline (day 1) ]
  • Feasibility of Intervention Measure (FIM) [ Time Frame: Post intervention (final study visit) ]
  • Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post intervention (final study visit) ]
  • Insomnia Severity Index (ISI) [ Time Frame: Post intervention (final study visit) ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Post intervention (final study visit) ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Post intervention (final study visit) ]
  • Canadian Occupation Performance Measure (COPM) [ Time Frame: Post intervention (final study visit) ]
  • Activity Card Sort (ACS) [ Time Frame: Post intervention (final study visit) ]

Central Contacts and Locations

Central contacts

Sepideh Zenoozi, PhD student

573-823-3082sznmx@missouri.edu

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Sepideh Zenoozi, MSOT

573-823-3082sznmx@missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

May 1, 2026

Last verified

Feb, 2026

Keywords

  • Sleep problems
  • Cognitive behavioral Therapy for insomnia
  • CBT-I
  • mild traumatic brain injury
  • mTBI
  • Functional performance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-05-01.