No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
360 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for people who have had a mild to moderate traumatic brain injury and are struggling with insomnia and PTSD symptoms. Participants will receive either cognitive behavioral therapy for insomnia or mindfulness-based treatment through telemedicine sessions.
Are You a Good Fit for This Trial?
You may be able to join if
I am a current or former member of the uniform services.
I have been diagnosed with traumatic brain injury.
More than 90 days have passed since my injury.
I have had insomnia for more than 90 days.
My insomnia severity score is above 10.
I can provide informed consent.
I am over 18 years old.
I have access to and can use a computer.
You may not be able to join if
I have a history of neurological diseases not related to my TBI.
I have sleep apnea with an apnea hypopnea index above 15.
I use a CPAP device but don't comply with usage requirements.
I cannot participate because I’m on unstable psychotropic medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-Tr…
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Current or former member of the uniform services
2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
3. Time duration since traumatic brain injury (TBI) injury \>90 days
4. Insomnia symptom duration \>90 days
5. Endorse insomnia sy…
Inclusion Criteria:
1. Current or former member of the uniform services
2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
3. Time duration since traumatic brain injury (TBI) injury \>90 days
4. Insomnia symptom duration \>90 days
5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10)
6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
7. \>18 years of age
8. Access to and ability and to use computer.
Exclusion Criteria:
1. History of neurological diseases other than TBI and not attributable to TBI
2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants 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. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
