CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Depression Clinical Trial

Official title:

CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663034
• Other study ID #: IRB00356930
• Secondary ID: 141686
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Luis Buenaver, PHD
• Phone: 4105507986
• Email: lbuenav1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

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 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; PHQ-8). Exploratory analyses will include neurocognitive functioning (ANAM) and pre-sleep arousal (PSAS).

Specific Aims are as follows:

Specific Aim 1: Compare telehealth-delivered CBT-I and MBTI in ameliorating insomnia and depressive symptoms among active-duty military personnel with mild to moderate TBI and comorbid insomnia.

Primary Hypothesis 1: MBTI will be non-inferior to CBT-I in reducing insomnia symptoms, as measured by the Insomnia Severity Index (ISI), at the end of treatment and at 6- and 12-weeks posttreatment (i.e., 12- and 24-weeks post-randomization).

Hypothesis 2: MBTI will be non-inferior to CBT-I in reducing depressive (as measured by the Patient Health Questionnaire-8 Item [PHQ-8]) symptoms at the end of treatment, and at 6- and 12-weeks posttreatment (i.e., 12- and 24-weeks post-randomization).

Specific Aim 2: Compare telehealth-delivered CBT-I and MBTI on insomnia severity and pre-sleep arousal in the subset of persons with TBI and comorbid insomnia who also have clinically elevated symptoms of posttraumatic stress.

Co-Primary Hypothesis 3: In the subset of persons with TBI AND clinically elevated PTSS (as defined by PTSD Checklist for Diagnostic and Statistical Manual-5 (DSM-5) score > 31) at baseline, MBTI will reduce insomnia symptom severity (i.e., ISI) significantly more than CBT-I at the end of treatment, and at 6- and 12-weeks post-treatment (i.e., 12- and 24-weeks post-randomization).

Hypothesis 4: In the subset of persons with TBI AND clinically elevated PTSS (as defined by PTSD Checklist for DSM-5 score > 31) at baseline, MBTI will reduce pre-sleep arousal (as measured by the Pre-sleep Arousal Scale [PSAS]), significantly more than CBT-I at the end of treatment, and at 6- and 12-weeks post-treatment (i.e., 12- and 24-weeks post-randomization).

Exploratory Aim 3: Explore mechanisms of telehealth CBT-I and MBTI on sleep and neurocognitive functioning in active-duty military personnel with mild to moderate TBI and comorbid symptoms of posttraumatic stress and insomnia.

Hypothesis 5: In the subset of persons with TBI AND clinically elevated PTSS (as defined by PTSD Checklist for DSM-5 score > 31) at baseline, improvements in sleep (i.e., ISI) will vary as a function of degree of improvement in pre-sleep arousal (as measured by the Pre-sleep Arousal Scale).

Hypothesis 6: The investigators hypothesize that improvements in neurocognitive functioning (i.e., attention, processing speed, working memory, memory, executive functioning), as measured by neuropsychological testing, will vary as a function of degree of improvement in sleep.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Meet the Veterans Affairs Medical Center (VAMC) and Department of Defense (DoD) criteria for TBI

2. Mild to moderate TBI severity at time of injury based on review of medical records

3. Time duration since injury >3 weeks

4. Endorse insomnia symptoms (Insomnia Severity Index [ISI] score > 9)

5. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA), Z-score > -2149)

6. 18 years of age or greater

7. Access to and ability and to use computer

Exclusion Criteria:

1. History of neurological diseases other than TBI and not attributable to TBI

2. Known history of intellectual or developmental disability

3. Communication difficulties or inability to speak English

4. Sleep apnea [apnea hypopnea index (AHI) >15; individuals with mild apnea (AHI > 5 and <14.9) will be informed, but allowed to participate].

Patients 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.

Patients using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Mild
• Cognitive Behavioral Therapy
• Concussion, Brain
• Craniocerebral Trauma
• Depression
• Head Injury
• Insomnia
• Memory Impairment
• Post-traumatic Stress
• Sleep
• Sleep Initiation and Maintenance Disorders
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Mindfulness-based treatment for insomnia (MBTI)
A 6-week intervention that uses the principles and practices of mindfulness meditation along with behavioral strategies (stimulus control, sleep restriction therapy) to reduce symptoms of insomnia
• Cognitive behavioral therapy for insomnia (CBT-I)
Standard of care for adults with chronic insomnia. 6-week program that uses behavioral techniques to decrease psychophysiological arousal and increase sleep propensity to deepen and consolidate sleep.

Locations

Country	Name	City	State
United States	Intrepid Spirit Center - Eglin Air Force Base	Eglin Air Force Base	Florida
United States	Naval School Explosive Ordance Disposal - Eglin Air Force Base	Eglin Air Force Base	Florida
United States	Womack Army Medical Center	Fort Bragg	North Carolina
United States	Madigan Army Medical Center	Fort Lewis	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Department of Defense Congressionally Directed Medical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Neurocognitive functioning as assessed by the Automated Neuropsychological Assessment Metrics (ANAM)	Neurocognitive functioning measured by Automated Neuropsychological Assessment Metrics (ANAM)	At the end of treatment, and 6- and 12-weeks post treatment
Primary	Change in Insomnia severity as assessed by the insomnia severity index (ISI)	Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms	At the end of treatment, and 6- and 12-weeks post treatment
Secondary	Change in Pre-sleep Arousal as assessed by the Pre-sleep Arousal Scale (PSAS)	Pre-sleep Arousal measured by Pre-sleep Arousal Scale (PSAS); Score range: 16-80; Higher scores are associated with greater pre-sleep arousal.	At the end of treatment, and 6- and 12-weeks post treatment
Secondary	Change in Depressive Symptoms as assessed by the Patient Health Questionnaire-8 Item (PHQ-8)	Depressive Symptoms measured by the Patient Health Questionnaire-8 Item (PHQ-8); Score range: 0-24; Higher scores are associated with greater depressive symptoms	At the end of treatment, and 6- and 12-weeks post treatment