CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Purpose
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).
Conditions
- Traumatic Brain Injury
- Insomnia
- Depression
- Post-traumatic Stress
- Sleep
- Memory Impairment
- Cognitive Behavioral Therapy
- Concussion, Brain
- Head Injury
- Brain Injury Traumatic Mild
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Current or former member of the uniformed services 2. Meet the Veterans Affairs Medical Center (VAMC) and Department of Defense (DoD) criteria for TBI 3. Time duration since injury > 90 days 4. Insomnia symptom duration > 90 days 5. Endorse insomnia symptoms (Insomnia Severity Index [ISI] score > 9) 6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA), Z-score > -2) 7. 18 years of age or greater 8. Access to and ability and to use computer
Exclusion Criteria
- 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 <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. 3. Patients using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Prospective two-arm, single blind randomized controlled trial
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- Investigators and outcome assessment technicians will remain blinded to treatment assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
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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). |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
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).
