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New treatment option for Insomnia
Official title Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury
ClinicalTrials.gov ID: NCT06867666
What this study is testing
- What it's testing
- The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI). The investigators will test the impact of CBT-I on insomnia symptoms as well as post-concussive symptoms, psychological symptoms, and neurocognitive functioning in comparison to treatment as usual.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Active duty Sailors, activated Reservist Sailors: The study focuses on the treatment in Sailors. Therefore, eligible participants must be active duty...
- Diagnosis of chronic insomnia; PSQI score \> 9: The study focuses on the treatment of insomnia. Therefore, eligible participants must have received a...
- History of TBI: The study focuses on the treatment of insomnia in Sailors with TBI. Therefore, eligible participants must have a confirmed history of...
- Stable for at least 8 weeks on psychotropic and hypnotic medications: ADSMs currently using prescribed psychotropic and hypnotic medications will be...
- Stable on continuous positive airway pressure therapy for sleep apnea for at least 90 days and usage of 4 hours or more per night, for at least 70%...
You likely can't join if
- Unable to give informed consent: Individuals who are unable to give informed consent cannot be enrolled in the study. A decisional capacity to...
- Severe TBI: Individuals with severe TBI will be excluded from this study due to complex medical needs which may require close medical attention and...
- Potential alcohol use disorder: Individuals who meet diagnostic criteria for current alcohol or substance use disorders will be excluded as these...
- Inability to comprehend or read English: Participants with demonstrated inability to comprehend or read English will not be eligible for the study...
- Serious mental health diagnosis such as bipolar disorder or psychosis; or seizure disorder: Participants who have been previously diagnosed with...
- Hypersomnia disorder: Potential participants that have been diagnosed with hypersomnia that can be exacerbated by the transient and mild sleep...
See the full eligibility criteria
Who can join
- Active duty Sailors, activated Reservist Sailors: The study focuses on the treatment in Sailors. Therefore, eligible participants must be active duty Navy, or activated Reservist Navy. Military personnel from other...
- Diagnosis of chronic insomnia; PSQI score \> 9: The study focuses on the treatment of insomnia. Therefore, eligible participants must have received a diagnosis of chronic insomnia by the study evaluators.
- History of TBI: The study focuses on the treatment of insomnia in Sailors with TBI. Therefore, eligible participants must have a confirmed history of TBI by the study evaluators.
- Stable for at least 8 weeks on psychotropic and hypnotic medications: ADSMs currently using prescribed psychotropic and hypnotic medications will be eligible to participate in the trial if they have been on the same...
- Stable on continuous positive airway pressure therapy for sleep apnea for at least 90 days and usage of 4 hours or more per night, for at least 70% of the nights: ADSM with comorbid with sleep disordered breathing (SDB)...
- Own a smart device: Participants in all three treatment delivery conditions will use the COAST app to complete the electronic daily sleep logs and study assessments. Thus, ownership of a smartphone will be required.
What rules you out
- Unable to give informed consent: Individuals who are unable to give informed consent cannot be enrolled in the study. A decisional capacity to consent test, which will be submitted for approval to the Institutional...
- Severe TBI: Individuals with severe TBI will be excluded from this study due to complex medical needs which may require close medical attention and pose safety concerns with regards to completing the study procedures.
- Potential alcohol use disorder: Individuals who meet diagnostic criteria for current alcohol or substance use disorders will be excluded as these conditions may perpetuate insomnia and daytime impairments and pose...
- Inability to comprehend or read English: Participants with demonstrated inability to comprehend or read English will not be eligible for the study. The intervention is highly dependent on understanding the treatment...
- Serious mental health diagnosis such as bipolar disorder or psychosis; or seizure disorder: Participants who have been previously diagnosed with psychotic or bipolar disorders, or who endorse symptoms of these...
- Hypersomnia disorder: Potential participants that have been diagnosed with hypersomnia that can be exacerbated by the transient and mild sleep deprivation induced by sleep restriction and stimulus control will not be...
- Working rotating shifts or requiring that the ADSM report to work earlier than 6am: Potential participants working rotating shifts or who are required to work earlier than 6am will not be included in the trial. Waking...
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.