Clinical trial NCT05683145: University of Colorado - Restoring Efficient Sleep After TBI
Official title: University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Traumatic Brain Injury
Keywords: computerized intervention
insomnia
traumatic brain injury
clinician guided
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: Colorado Traumatic Brain Injury Trust Fund
name: University of Colorado, Denver
First posted: 2023-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel, two-arm, randomized control trial
Primary purpose: TREATMENT

Brief summary: Sleep disturbance is a common condition following traumatic brain injury (TBI) and impairs recovery and quality of life. While efficacious interventions exist many are not accessible to all patients due to a variety of factors (e.g., rurality, access to providers). Further, many of the available treatments have not been validated for individuals with moderate/severe TBI. The proposed study will evaluate a guided computerized version of cognitive behavioral therapy for insomnia (cCBT-I) against enhanced treatment as usual (ETU) in individuals with moderate/severe TBI.

Detailed description: Individuals with a history of moderate to severe TBI experience multi-faceted sleep problems, including greater daytime sleepiness, lesser total sleep time, and difficulties with initiating, maintaining, and self-monitoring sleep. Such sleep complaints may reflect underlying sleep conditions such as insomnia, the prevalence of which is significantly greater among individuals with TBI (29%) compared to members of the general population (10%). As such, treatment of insomnia among individuals with moderate to severe TBI is expected to produce wide-ranging benefits in regards to short- and long-term rehabilitation. Among members of the general population, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard for treating insomnia. CBT-I focuses on improving sleep quality via cognitive therapy, behavioral techniques, and psychoeducation. However, access to in-person treatment has been limited by cost, insufficient numbers of adequately trained healthcare providers, and patient perceptions regarding the efficacy of the intervention, as well as additional barriers that may be particularly pertinent for those living with moderate to severe TBI (e.g., limited transportation). Optimally, an intervention for those with TBI and insomnia would show efficacy at reversing sleep inefficiency, and be able to be used with minimal stigma. In addition, the intervention should be highly accessible, low cost, self-sustaining (e.g., portable), and with minimal side effects.

Computerized versions of CBT-I assist in reducing barriers to access and have been found to be acceptable and efficacious in a variety of populations, including those with mild TBI. To date, research among those with moderate to severe TBI has been limited. This study will address this gap by examining the efficacy of a guided computerized CBT-I (CCBT-I) intervention for those with moderate to severe TBI and insomnia. That is, we will implement a free, computerized version of CBT-I, provided in conjunction with guidance (e.g., prompts or reminders to complete modules, help or support using the program and/or completing the modules) by a licensed mental health professional (Study Clinician). As participants will be recruited from the community at-large across the State of Colorado, it is believed that findings will be highly generalizable.

Moreover, both geography (where an individual resides) and challenges with transportation create barriers to treatment access and research participation among those living with moderate to severe TBI. As such, all study procedures will be completed remotely. During the Coronavirus Disease 2019 (COVID-19) pandemic, members of this study team explored and implemented multiple methods to facilitate remote research participation (e.g., video conferencing, data collection via Research Electronic Data Capture \[REDCap\], mailing study data collection devices). Employing such methods will allow individuals in both rural and urban areas across Colorado to participate.

Eligibility criteria: Inclusion Criteria:

* History of post-acute (i.e., at least one year after injury) moderate to severe traumatic brain injury
* Current insomnia
* Reliable access to the internet
* Ability to provide informed consent

Exclusion Criteria:

* Active substance dependence, excluding cannabis
* Current psychosis
* Bipolar disorder
* Current sleep disorders other than insomnia, including sleep apnea
* Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns.
* Currently receiving psychological treatment for insomnia
* Pregnancy
* Currently involved in another research interventional trial targeting insomnia

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline to post-intervention (CCBT-I arm) or 9 weeks following randomization (ETU arm).
Secondary outcomes:
Other outcomes:
measure: Total sleep time - discrepancy between sleep diary and actigraphy
timeFrame: Two timepoints: One week prior to the start of the intervention and for the week immediately following completion of the intervention
measure: Sleep onset latency - discrepancy between sleep diary and actigraphy
timeFrame: Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention
measure: Wake after sleep onset - discrepancy between sleep diary and actigraphy
timeFrame: Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention
measure: Sleep efficiency - discrepancy between sleep diary and actigraphy
timeFrame: Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention
measure: Nature and duration of guidance needed to compete intervention
timeFrame: Through study completion, an average of 9 weeks
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VAMC
state: Colorado
Study officials:
affiliation: Rocky Mountain VA Mental Illness, Research, and Education Center
name: Lisa A Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: