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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of talk therapy to assist military service members struggling with sleep after a mild head injury. It compares six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I). The aim is to determine which therapy more effectively improves sleep problems and ongoing issues from the head injury. This trial suits service members who have experienced sleep troubles and other symptoms from a concussion for at least three months. Participants should maintain stable medication and treatment plans if using sleep aids or treatments for sleep apnea. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance sleep therapies for others in the future.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Cognitive Behavioral Therapy for Insomnia (CBT-I) and Brief Behavioral Therapy for Insomnia (BBT-I) are safe and effective for treating insomnia.

Studies have found that CBT-I not only improves sleep in people with concussions but also reduces symptoms related to concussions and mood issues, enhancing overall well-being. Since it doesn't involve medication, it avoids drug-related side effects, making it a safe choice.

For BBT-I, many clinical trials have proven it improves sleep. Like CBT-I, it focuses on changing sleep habits and thoughts about sleep rather than using medication. This approach is generally well-tolerated, with few or no side effects.

Overall, both therapies are considered safe because they don't involve drugs. They are widely used and recommended for managing insomnia, even in individuals with mild traumatic brain injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for insomnia in concussions because they offer tailored behavioral approaches that can be more convenient and accessible than traditional methods like medication. Cognitive Behavioral Therapy for Insomnia (CBT-I) involves six weekly, 50-minute sessions that can be delivered in-person or through telehealth, providing flexibility and a comprehensive approach to changing sleep habits. Meanwhile, Brief Behavioral Therapy for Insomnia (BBT-I) is a shorter option with four weekly, 30-minute sessions, making it a quicker, yet still effective, alternative for those seeking rapid improvement. Both therapies focus on modifying behaviors and thought patterns associated with insomnia, offering a drug-free solution that directly addresses the root causes of sleep issues linked with concussions.

What evidence suggests that this trial's treatments could be effective for insomnia in concussions?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), one of the therapies studied in this trial, improves sleep. Studies indicate that 70-80% of people with insomnia experience long-lasting benefits from CBT-I, and about 50% see a significant reduction in symptoms. For military members with traumatic brain injury (TBI), online CBT-I has produced promising results in enhancing sleep quality.

Brief Behavioral Therapy for Insomnia (BBT-I) is another therapy under study in this trial. Many participants remain in the program, and positive feedback suggests it could effectively treat insomnia. BBT-I focuses on quickly improving sleep patterns with shorter sessions. Both therapies are being studied for their potential to help those with insomnia and ongoing symptoms after a concussion. ^{1 6 7 8 9}

Who Is on the Research Team?

Kristi E Pruiksma, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

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 score at least 15 on the Insomnia Severity Index.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06551987

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12215294/

Preliminary feasibility and efficacy of a brief behavioural ... BBTI was found to be well tolerated, as evidenced by the high overall retention rates (70%) and positive feedback on the treatment acceptability questionnaire.

3. trialx.com trialx.com/clinical-trials/listings/296041/behavioral-insomnia-treatment-in-mild-traumatic-brain-injury/?&geo_lat=31.1950013&geo_lng=-97.7413143&radius=10&place=Fort%20Hood&user_country=United%20States

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury This study will explore the impact of insomnia treatment on prolonged postconcussive symptoms and blood-based biomarkers. The overall objective ...

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999304001820

Cognitive behavioral therapy for insomnia associated with ... Results. Sleep onset decreased from 47 to 18 minutes, and nocturnal awakenings dropped from 85 to 28 minutes on average at posttreatment. Sleep efficiency also ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38466122/

Cognitive Behavioral Therapy for Insomnia Improves Sleep ... CBT-I reduces insomnia in individuals with concussions, and improved sleep was associated with lower postconcussion and mood symptoms.

7. tandfonline.com tandfonline.com/doi/full/10.1080/15402002.2022.2082429

Adapting Brief Behavioral Treatment for Insomnia ... Robust evidence from numerous clinical trials demonstrates cognitive behavioral therapy for insomnia (CBT-I) improves sleep outcomes in ...

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8986

Behavioral and psychological treatments for chronic insomnia ... This guideline establishes clinical practice recommendations for the use of behavioral and psychological treatments for chronic insomnia disorder in adults.

9. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2024-2eb22

Behavioral Therapy for Insomnia in Concussions Participants receiving CBT-I also experienced better sleep quality, reduced dysfunctional beliefs about sleep, and a modest decrease in postconcussion symptoms ...