CBT-I vs MBTI for Insomnia after Traumatic Brain Injury
CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Recruiting
N/A
Interventional Study
Traumatic Brain Injury
Insomnia
Depression
Post-traumatic Stress
Sleep
Memory Impairment
Cognitive Behavioral Therapy
Concussion, Brain
Head Injury
Brain Injury Traumatic Mild
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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 a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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…
Trial Locations
Loading…
Loading trial locations…
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…
Contacts