Clinical trial NCT05663034: CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Official title: CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Insomnia
Depression
Post-traumatic Stress
Sleep
Memory Impairment
Cognitive Behavioral Therapy
Concussion, Brain
Head Injury
Brain Injury Traumatic Mild
Keywords: Traumatic Brain Injury
Insomnia
Posttraumatic Stress Symptoms
Depression
Concussion
Head Injury
Brain Injury
Cognitive Behavioral Therapy for Insomnia
Mindfulness-based Treatment for Insomnia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Department of Defense Congressionally Directed Medical Research Program
First posted: 2022-12-23
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective two-arm, single blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Detailed description: This study is a prospective two-arm, randomized single blind controlled trial design to compare the clinical effectiveness of telemedicine-delivered cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia. A cohort of n=360 adults with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia will be randomized to receive either telemedicine-delivered CBT-I or MBTI. Consistent with previous scientific literature, the interventions will be standardized and six sessions in length. All participants will wear an actigraph wrist monitor throughout the course of the project. All participants will also complete electronic sleep diaries throughout the course of the project. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, ambulatory EEG sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment (12- and 24-weeks post randomization, respectively). The primary outcome is insomnia severity (ISI) and secondary outcomes are pre-sleep arousal, and depressive symptoms (PSAS; Patient Health Questionnaire (PHQ-8). Exploratory analyses will include neurocognitive functioning (ANAM) and pre-sleep arousal (PSAS).

Eligibility criteria: Inclusion Criteria:

1. Current or former member of the uniform services
2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
3. Time duration since traumatic brain injury (TBI) injury \>90 days
4. Insomnia symptom duration \>90 days
5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10)
6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
7. \>18 years of age
8. Access to and ability and to use computer.

Exclusion Criteria:

1. History of neurological diseases other than TBI and not attributable to TBI
2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP, are adherent to using the device (\> 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation.
3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

Primary outcomes:
measure: Change in Insomnia severity as assessed by the insomnia severity index (ISI)
timeFrame: At the end of treatment, and 2-, 6- and 12-weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Eglin Air Force Base
country: United States
facility: Intrepid Spirit Center - Eglin Air Force Base
state: Florida
city: Eglin Air Force Base
country: United States
facility: Naval School Explosive Ordance Disposal - Eglin Air Force Base
state: Florida
city: Bethesda
country: United States
facility: Walter Reed National Medical Military Center
state: Maryland
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
city: Fort Lewis
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Luis Buenaver, PhD
role: PRINCIPAL_INVESTIGATOR
References: