Cognitive Behavioral Therapy for Insomnia after TBI

(CU-REST Trial)

Overseen By Emerald Saldyt

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Eastern Colorado Health Care System

Disqualifiers: Substance dependence, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with moderate to severe traumatic brain injury (TBI) who experience insomnia. Researchers are testing a computerized version of cognitive behavioral therapy for insomnia (cCBT-I) to determine if it improves sleep more effectively than usual care. Participants will either use this computerized therapy with some professional guidance or continue with their regular treatment while providing study data. Candidates may qualify if they have had a TBI for over a year, experience sleep difficulties, and have internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep treatments for TBI patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this computerized therapy is safe for individuals with TBI?

Research has shown that computerized cognitive behavioral therapy for insomnia (cCBT-I) is generally safe and well-received, even among individuals with traumatic brain injuries (TBI). In a study involving military service members and veterans with TBI, cCBT-I proved beneficial without major safety concerns. Another study compared online CBT for insomnia with an educational program and found it effective, further indicating its safety.

For individuals with TBI, sleep problems like insomnia are common, and cCBT-I offers a promising treatment with minimal risk. Although data on side effects is limited, current research suggests it is a safe option for managing insomnia in this group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the computerized Cognitive Behavioral Therapy for Insomnia (CBT-I) because it offers a unique, self-guided approach with professional support, making it more accessible compared to traditional, in-person therapy sessions. Unlike standard treatments like medication or in-person therapy, this program is delivered online, allowing individuals to engage with it at their own pace and convenience. This flexibility and the integration of professional guidance promise to make effective insomnia treatment more widely available, particularly for those recovering from traumatic brain injury (TBI).

What evidence suggests that computerized cognitive behavioral therapy for insomnia is effective for sleep disturbances after TBI?

Research has shown that computerized cognitive behavioral therapy for insomnia (CBT-I), which participants in this trial may receive, works well for many people with sleep issues. In one study, about 70-80% of people with insomnia experienced lasting improvements, and around 50% found their insomnia was no longer a problem. For those with a traumatic brain injury (TBI), research found that CBT-I helped them sleep better. People with TBI often have trouble sleeping, and this therapy has shown promise in helping them. Overall, CBT-I seems to be a good option for improving sleep after a TBI. ^{2 4 5 6 7}

Who Is on the Research Team?

Lisa A Brenner, PhD

Principal Investigator

Rocky Mountain VA Mental Illness, Research, and Education Center

Are You a Good Fit for This Trial?

This trial is for individuals who have had a moderate to severe traumatic brain injury at least one year ago and are now experiencing insomnia. Participants must have reliable internet access and be able to consent. They can't join if they're dependent on substances (except cannabis), pregnant, dealing with psychosis or bipolar disorder, in another sleep study, getting psychological treatment for insomnia, or have irregular sleep patterns due to work or life changes.

Inclusion Criteria

Reliable access to the internet

Ability to provide informed consent

Exclusion Criteria

Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns

Active substance dependence, excluding cannabis

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a guided computerized version of cognitive behavioral therapy for insomnia (cCBT-I) with assistance from a licensed mental health professional

9 weeks

Remote participation

Follow-up

Participants are monitored for changes in sleep metrics and insomnia severity after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Cognitive Behavioral Therapy for Insomnia

Trial Overview The study is testing a guided computerized cognitive behavioral therapy program for insomnia (cCBT-I) against an enhanced usual care approach in people with past traumatic brain injuries. It aims to see if this online therapy can improve sleep quality when traditional treatments aren't accessible.

How Is the Trial Designed?

Group I: Computerized Cognitive Behavioral Therapy for Insomnia Experimental Treatment 1 Intervention

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

Group II: Enhanced Treatment as Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials

55

Recruited

26,200+

Colorado Traumatic Brain Injury Trust Fund

Collaborator

Trials

4

Recruited

2,100+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11234237/

Internet-Guided Cognitive Behavioral Therapy for Insomnia ... This randomized clinical trial compares internet-based cognitive behavioral therapy for insomnia and an internet-based education control ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424001083

A randomized clinical trial for a self-guided sleep ... This is a randomized controlled trial of a CCBT-I intervention for individuals with current insomnia and a history of moderate-severe TBI.

3. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2023.1268967/full

Cognitive behavioral therapy for insomnia in a military ... Research indicates that between 70 and 80% of patients with insomnia experience sustained benefits from CBTi and ~50% experience clinical remission ((Dietch ...

4. uchealth.org uchealth.org/today/online-therapy-aims-to-ease-insomnia-for-people-with-tbi/

Online therapy aims to ease insomnia for people with TBI People with TBIs are three times more likely to suffer from insomnia. A new study uses CBT to treat insomnia in those with TBI.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8601855/

Effects of Cognitive Behavioral Therapy on Pain and Sleep ... The underpowered evidence suggested that CBT is effective in the management of sleep quality and pain in TBI adults.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820897

Internet-Guided Cognitive Behavioral Therapy for Insomnia ... These findings suggest that when successfully completed, eCBT-I can provide clinical benefits in military service members and veterans with TBI and insomnia.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05663034

NCT05663034 | CBT-I vs. MBTI for Traumatic Brain Injury ... This study is a prospective two-arm, randomized single blind controlled trial design to compare the clinical effectiveness of telemedicine-delivered cognitive ...