Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05663034 |
| Other study ID # |
IRB00356930 |
| Secondary ID |
141686 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2024 |
| Est. completion date |
September 2026 |
Study information
| Verified date |
March 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.
