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

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05663034

Collaborator

Department of Defense Congressionally Directed Medical Research Program (Other)

360

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Insomnia Depression Post-traumatic Stress Sleep Memory Impairment Cognitive Behavioral Therapy Concussion, Brain Head Injury Brain Injury Traumatic Mild	Behavioral: Mindfulness-based treatment for insomnia (MBTI) Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)	N/A

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective two-arm, single blind randomized controlled trialProspective two-arm, single blind randomized controlled trial

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Investigators and outcome assessment technicians will remain blinded to treatment assignment.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cognitive behavioral therapy for insomnia (CBT-I) CBT-I treatment will involve a standardized 6-session blended intervention that combines cognitive and behavioral techniques. The core components include (1) education about sleep and insomnia, stimulus control (SC) and sleep restriction (SRT) (week 1); (2) sleep hygiene education (week 2); and (3) relaxation training, cognitive restructuring (to counter-arousal and address sleep-interfering cognitions), adherence monitoring, and adjusting the recommended sleep-wake schedule (weeks 3 through 6). The final session will also include a review of treatment content and relapse prevention. Common to all sessions is an initial review of participant diary data, charting progress, setting measurable goals, discussing adherence, and reinforcing learned skills.	Behavioral: 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.
Active Comparator: Mindfulness-based treatment for insomnia (MBTI) MBTI treatment will involve a standardized 6-session intervention which integrates the mindfulness training and exercises from mindfulness-based stress reduction (MBSR) with behavioral strategies based on sleep restriction therapy and stimulus control delivered within the context of mindfulness principles. Mindfulness principles include: 1) increase awareness of the mental and physical states that promote sleep (i.e., sleepiness), 2) shift sleep-related metacognitions to reduce hyperarousal, and 3) promote a mindful stance to respond when symptoms of insomnia arise. An overview of the treatment program, sleep education, and an introduction to the principles of mindfulness meditation is given (week 1). Then a combination of mindfulness meditations, sleep restriction, and stimulus control is conducted (week 2-6).	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

Arm

Intervention/Treatment

Active Comparator: Cognitive behavioral therapy for insomnia (CBT-I)

CBT-I treatment will involve a standardized 6-session blended intervention that combines cognitive and behavioral techniques. The core components include (1) education about sleep and insomnia, stimulus control (SC) and sleep restriction (SRT) (week 1); (2) sleep hygiene education (week 2); and (3) relaxation training, cognitive restructuring (to counter-arousal and address sleep-interfering cognitions), adherence monitoring, and adjusting the recommended sleep-wake schedule (weeks 3 through 6). The final session will also include a review of treatment content and relapse prevention. Common to all sessions is an initial review of participant diary data, charting progress, setting measurable goals, discussing adherence, and reinforcing learned skills.

Behavioral: 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.

Active Comparator: Mindfulness-based treatment for insomnia (MBTI)

MBTI treatment will involve a standardized 6-session intervention which integrates the mindfulness training and exercises from mindfulness-based stress reduction (MBSR) with behavioral strategies based on sleep restriction therapy and stimulus control delivered within the context of mindfulness principles. Mindfulness principles include: 1) increase awareness of the mental and physical states that promote sleep (i.e., sleepiness), 2) shift sleep-related metacognitions to reduce hyperarousal, and 3) promote a mindful stance to respond when symptoms of insomnia arise. An overview of the treatment program, sleep education, and an introduction to the principles of mindfulness meditation is given (week 1). Then a combination of mindfulness meditations, sleep restriction, and stimulus control is conducted (week 2-6).

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

Outcome Measures

Primary Outcome Measures

Change in Insomnia severity as assessed by the insomnia severity index (ISI) [At the end of treatment, and 6- and 12-weeks post treatment]
Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms

Secondary Outcome Measures

Change in Pre-sleep Arousal as assessed by the Pre-sleep Arousal Scale (PSAS) [At the end of treatment, and 6- and 12-weeks post treatment]
Pre-sleep Arousal measured by Pre-sleep Arousal Scale (PSAS); Score range: 16-80; Higher scores are associated with greater pre-sleep arousal.
Change in Depressive Symptoms as assessed by the Patient Health Questionnaire-8 Item (PHQ-8) [At the end of treatment, and 6- and 12-weeks post treatment]
Depressive Symptoms measured by the Patient Health Questionnaire-8 Item (PHQ-8); Score range: 0-24; Higher scores are associated with greater depressive symptoms

Other Outcome Measures

Change in Neurocognitive functioning as assessed by the Automated Neuropsychological Assessment Metrics (ANAM) [At the end of treatment, and 6- and 12-weeks post treatment]
Neurocognitive functioning measured by Automated Neuropsychological Assessment Metrics (ANAM)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meet the Veterans Affairs Medical Center (VAMC) and Department of Defense (DoD) criteria for TBI
Mild to moderate TBI severity at time of injury based on review of medical records
Time duration since injury >3 weeks
Endorse insomnia symptoms (Insomnia Severity Index [ISI] score > 9)
Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA), Z-score > -2149)
18 years of age or greater
Access to and ability and to use computer

Exclusion Criteria:

History of neurological diseases other than TBI and not attributable to TBI
Known history of intellectual or developmental disability
Communication difficulties or inability to speak English
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.