Behavioral Therapy for Insomnia in Concussions

Overseen By Kristi E. Pruiksma, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Moderate TBI, Urgent psychiatric disorder, others

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

Compensation: Varies

Number of Visits: 13

Duration: 6 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).

Will I have to stop taking my current medications?

The trial requires that participants be stable on their current psychotropic and hypnotic medications for at least 1 month before joining. This means you should not change these medications right before or during the trial.

What data supports the effectiveness of the treatment for insomnia in concussions?

Research shows that cognitive-behavioral therapy for insomnia (CBT-I) is effective in treating insomnia, including in cases related to traumatic brain injury (TBI). Brief Behavioral Therapy for Insomnia (BBTI) has also been shown to reduce insomnia symptoms and is effective in various settings, making it a promising option for those with sleep issues after a concussion. ^{1 2 3 4 5}

Is behavioral therapy for insomnia safe for humans?

Behavioral therapies for insomnia, like CBT-I and BBTI, are generally considered safe for humans. They have been used effectively in various populations, including older adults and veterans, without significant safety concerns. ^{1 3 5 6 7}

How is the treatment for insomnia in concussions unique?

The treatment uses Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a non-drug approach that focuses on changing sleep habits and behaviors to improve sleep. It is unique because it addresses insomnia specifically in the context of concussions, potentially improving not just sleep but also related symptoms like mood and pain. ^{1 2 3 8 9}

Research Team

Kristi E Pruiksma, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for active duty U.S. military service members aged 18 or older who have had a mild traumatic brain injury at least 3 months ago and are experiencing insomnia. They must be able to consent, follow instructions, stay in the area for 3 months, and have stable medication use if applicable.

Inclusion Criteria

I am an active duty U.S. military service member.

I score at least 15 on the Insomnia Severity Index.

I can understand and agree to the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Behavioral Therapy for Insomnia (CBT-I) or Brief Behavioral Therapy for Insomnia (BBT-I) with sessions delivered in-person or via telehealth

6 weeks

6 weekly sessions for CBT-I, 4 weekly sessions for BBT-I

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

7-week and 12-week follow-up assessments

Treatment Details

Interventions

• Brief Behavioral Therapy for Insomnia
• Cognitive Behavioral Therapy for Insomnia

Trial Overview The study compares two treatments for insomnia after a brain injury: six sessions of Cognitive Behavioral Therapy (CBT-I) versus four sessions of Brief Behavioral Therapy (BBT-I). Participants will be randomly assigned to one of these two approaches.

Participant Groups

Group I: Cognitive Behavioral Therapy for Insomnia Active Control 1 Intervention

6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Group II: Brief Behavioral Therapy for Insomnia Active Control 1 Intervention

4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Brief Behavioral Therapy for Insomnia is already approved in United States for the following indications:

Approved in United States as BBT-I for:

• Insomnia
• Postconcussive symptoms in Mild Traumatic Brain Injury

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Hope Health Research Institute

Collaborator

Trials

1

Recruited

160+

Findings from Research

In a pilot study involving 24 adolescents aged 12 to 18 years, 6 weeks of cognitive-behavioral therapy for insomnia (CBT-I) led to significant improvements in insomnia symptoms, which were maintained even 4 weeks after treatment ended.

Participants receiving CBT-I also experienced better sleep quality, reduced dysfunctional beliefs about sleep, and a modest decrease in postconcussion symptoms compared to those receiving standard treatment, indicating CBT-I's potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Insomnia in Adolescents With Persistent Postconcussion Symptoms. Tomfohr-Madsen, L., Madsen, JW., Bonneville, D., et al.[2021]

Cognitive Behavioral Therapy (CBT) for insomnia significantly improved sleep quality in a man with a traumatic brain injury, reducing sleep onset time from 47 to 18 minutes and nocturnal awakenings from 85 to 28 minutes after eight weekly sessions.

Polysomnography confirmed these improvements, showing a decrease in total awake time and number of awakenings, with benefits maintained at 1- and 3-month follow-ups, indicating that CBT could be an effective non-drug treatment for insomnia following TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia associated with traumatic brain injury: a single-case study. Ouellet, MC., Morin, CM.[2018]

Cognitive-behavioral therapy for insomnia (CBT-I) shows promise in improving sleep efficiency and quality in individuals with traumatic brain injury (TBI), based on a review of five studies.

Despite positive outcomes, the review highlights a significant limitation due to the small number of participants and studies, indicating a need for more comprehensive research to confirm the efficacy of CBT-I in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does cognitive-behavioural therapy improve sleep outcomes in individuals with traumatic brain injury: a scoping review. Ludwig, R., Vaduvathiriyan, P., Siengsukon, C.[2021]

Brief behavioral treatment for insomnia (BBTI) is a 4-session program that can effectively reduce insomnia symptoms, such as difficulty falling asleep and waking up during the night, making it a practical option for non-psychologist health professionals to administer.

BBTI has shown promising results, including cases of full remission from insomnia, and ongoing clinical trials are exploring its efficacy in different treatment settings and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. Gunn, HE., Tutek, J., Buysse, DJ.[2019]

Brief Behavioral Treatment for Insomnia (BBTI) is a concise, four-session therapy designed to overcome barriers to accessing traditional cognitive-behavioral therapy for insomnia (CBTI), making it easier for clinicians to deliver.

BBTI has shown efficacy in treating older adults with insomnia, providing a practical alternative to standard CBTI, which is limited by a shortage of trained clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of insomnia with brief behavioral treatment (BBTI). Troxel, WM., Germain, A., Buysse, DJ.[2022]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

The Veterans Health Administration developed a digital mental health intervention called Path to Better Sleep (PTBS) to provide accessible cognitive behavioral therapy for insomnia (CBT-I) to veterans, addressing the shortage of trained providers.

Feedback from veteran and spouse evaluation panels significantly influenced the design of PTBS, leading to improvements in user engagement by emphasizing CBT-I efficacy, simplifying content, and incorporating relatable veteran testimonials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. Ryan, AT., Brenner, LA., Ulmer, CS., et al.[2023]

Insomnia affects 30-50% of patients with mild traumatic brain injury (mTBI) and is unlikely to resolve without specific treatment, making it a crucial target for improving recovery.

Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment, showing effectiveness in 70-80% of insomnia patients, but its efficacy specifically for insomnia related to mTBI needs further clinical testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Cognitive Behavioral Therapy for Insomnia Is a Promising Intervention for Mild Traumatic Brain Injury. Dietch, JR., Furst, AJ.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) did not lead to clinically significant improvements in insomnia severity for three participants with traumatic brain injury (TBI), but trends toward improvement were noted.

All participants experienced significant reductions in anxiety, with effects lasting for two of them at follow-up, indicating that CBT-I may help alleviate mood disturbances associated with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Cognitive Behavioral Therapy for Insomnia also treat fatigue, pain, and mood symptoms in individuals with traumatic brain injury? - A multiple case report. Lu, W., Krellman, JW., Dijkers, MP.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Insomnia in Adolescents With Persistent Postconcussion Symptoms. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia associated with traumatic brain injury: a single-case study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Does cognitive-behavioural therapy improve sleep outcomes in individuals with traumatic brain injury: a scoping review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Clinical management of insomnia with brief behavioral treatment (BBTI). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Perspective: Cognitive Behavioral Therapy for Insomnia Is a Promising Intervention for Mild Traumatic Brain Injury. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Can Cognitive Behavioral Therapy for Insomnia also treat fatigue, pain, and mood symptoms in individuals with traumatic brain injury? - A multiple case report. [2018]