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

Primary Purpose

Traumatic Brain Injury, Insomnia, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-based treatment for insomnia (MBTI)
Cognitive behavioral therapy for insomnia (CBT-I)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Insomnia, Posttraumatic Stress Symptoms, Depression, Concussion, Head Injury, Brain Injury, Cognitive Behavioral Therapy for Insomnia, Mindfulness-based Treatment for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Cognitive behavioral therapy for insomnia (CBT-I)

    Mindfulness-based treatment for insomnia (MBTI)

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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

    Full Information

    First Posted
    December 14, 2022
    Last Updated
    October 6, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    Department of Defense Congressionally Directed Medical Research Program
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05663034
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    Department of Defense Congressionally Directed Medical Research Program

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective two-arm, single blind randomized controlled trial
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Investigators and outcome assessment technicians will remain blinded to treatment assignment.
    Allocation
    Randomized
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive behavioral therapy for insomnia (CBT-I)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Mindfulness-based treatment for insomnia (MBTI)
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-based treatment for insomnia (MBTI)
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive behavioral therapy for insomnia (CBT-I)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Insomnia severity as assessed by the insomnia severity index (ISI)
    Description
    Insomnia symptoms and severity measured by insomnia severity index (ISI); score range: 0-28; Higher scores are associated with greater insomnia symptoms
    Time Frame
    At the end of treatment, and 6- and 12-weeks post treatment
    Secondary Outcome Measure Information:
    Title
    Change in Pre-sleep Arousal as assessed by the Pre-sleep Arousal Scale (PSAS)
    Description
    Pre-sleep Arousal measured by Pre-sleep Arousal Scale (PSAS); Score range: 16-80; Higher scores are associated with greater pre-sleep arousal.
    Time Frame
    At the end of treatment, and 6- and 12-weeks post treatment
    Title
    Change in Depressive Symptoms as assessed by the Patient Health Questionnaire-8 Item (PHQ-8)
    Description
    Depressive Symptoms measured by the Patient Health Questionnaire-8 Item (PHQ-8); Score range: 0-24; Higher scores are associated with greater depressive symptoms
    Time Frame
    At the end of treatment, and 6- and 12-weeks post treatment
    Other Pre-specified Outcome Measures:
    Title
    Change in Neurocognitive functioning as assessed by the Automated Neuropsychological Assessment Metrics (ANAM)
    Description
    Neurocognitive functioning measured by Automated Neuropsychological Assessment Metrics (ANAM)
    Time Frame
    At the end of treatment, and 6- and 12-weeks post treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luis Buenaver, PHD
    Phone
    4105507986
    Email
    lbuenav1@jhmi.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tara Taylor, MPH
    Email
    ttaylo56@jhu.edu

    12. IPD Sharing Statement

    Learn more about this trial

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

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