Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05663034
Other study ID # IRB00356930
Secondary ID 141686
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A