CU-REST: University of Colorado - Restoring Efficient Sleep After TBI

Sponsor

VA Eastern Colorado Health Care System (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT05683145

Collaborator

Colorado Traumatic Brain Injury Trust Fund (Other), University of Colorado, Denver (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Traumatic Brain Injury	Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel, two-arm, randomized control trialparallel, two-arm, randomized control trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

University of Colorado - Restoring Efficient Sleep After TBI (CU-REST)

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Computerized Cognitive Behavioral Therapy for Insomnia Self-guided computerized CBT-I program with assistance from a licensed mental health professional.	Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia This is a computerized version of cognitive behavioral therapy for insomnia that is augmented by support from a licensed mental health professional. The intervention consists of 6 modules designed to provide education regarding sleep and insomnia, establish behavioral modifications to reduce insomnia symptoms, and monitor progress. Participants will be able to complete these intervention at their own pace, which will take between 6-9 weeks.
No Intervention: Enhanced Treatment as Usual ETU is defined as treatment per usual which is enhanced by participating in data collection related to study participation.

Arm

Intervention/Treatment

Experimental: Computerized Cognitive Behavioral Therapy for Insomnia

Self-guided computerized CBT-I program with assistance from a licensed mental health professional.

Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia

This is a computerized version of cognitive behavioral therapy for insomnia that is augmented by support from a licensed mental health professional. The intervention consists of 6 modules designed to provide education regarding sleep and insomnia, establish behavioral modifications to reduce insomnia symptoms, and monitor progress. Participants will be able to complete these intervention at their own pace, which will take between 6-9 weeks.

No Intervention: Enhanced Treatment as Usual

ETU is defined as treatment per usual which is enhanced by participating in data collection related to study participation.

Outcome Measures

Primary Outcome Measures

Insomnia Severity Index (ISI) [Change from baseline to post-intervention (CCBT-I arm) or 9 weeks following randomization (ETU arm).]
The change in the total score of the ISI, compared across study arms, will be used as the outcome.

Other Outcome Measures

Total sleep time - discrepancy between sleep diary and actigraphy [Two timepoints: One week prior to the start of the intervention and for the week immediately following completion of the intervention]
Change in the discrepancy between sleep diary- and actigraphy-derived total sleep time will be evaluated for the CCBT-I arm.
Sleep onset latency - discrepancy between sleep diary and actigraphy [Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention]
Change in the discrepancy between sleep diary- and actigraphy-derived sleep onset latency will be evaluated for the CCBT-I arm.
Wake after sleep onset - discrepancy between sleep diary and actigraphy [Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention]
Change in the discrepancy between sleep diary- and actigraphy-derived wake after sleep onset will be evaluated for the CCBT-I arm.
Sleep efficiency - discrepancy between sleep diary and actigraphy [Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention]
Change in the discrepancy between sleep diary- and actigraphy-derived sleep efficiency will be evaluated for the CCBT-I arm.
Nature and duration of guidance needed to compete intervention [Through study completion, an average of 9 weeks]
A full descriptive analysis of participant use of study clinician support will be conducted to assess scalability (CCBT-I arm only). This will be recorded through an electronic log by the study clinician following each contact with a participant. The unit of measure will include items such as the frequency of contact with the study clinician and a qualitative analysis of the nature of the support given.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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