Cognitive Behavioral Therapy for Traumatic Brain Injury

SZ
Overseen BySepideh Zenoozi, PhD student
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Missouri-Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cognitive Behavioral Therapy for Insomnia (CBT-I) to assist individuals with mild traumatic brain injury (mTBI) who experience sleep difficulties. The goal is to determine if this therapy can enhance sleep and alleviate mTBI symptoms, thereby facilitating daily activities for participants. The trial seeks individuals diagnosed with mTBI by a doctor who have experienced sleep problems for over four weeks. Participants will engage in six weekly online sessions, focusing on techniques to improve sleep. As an unphased trial, this study provides participants the opportunity to contribute to understanding how CBT-I specifically benefits those with mTBI.

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 cognitive behavioral therapy for insomnia is safe for individuals with mild traumatic brain injury?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe. Studies have found it significantly improves sleep and mental function in individuals with mild cognitive issues. One study found that CBT-I helps military members and veterans with brain injuries sleep better. A review of multiple studies confirmed that CBT-I improves sleep quality and reduces insomnia symptoms for those with brain injuries. These findings suggest that CBT-I is well-tolerated and can be helpful for individuals with mild traumatic brain injury who have sleep problems.12345

Why are researchers excited about this trial?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it specifically targets sleep problems often experienced after a mild traumatic brain injury (mTBI). Unlike standard sleep medications, which primarily address symptoms by altering brain chemistry, CBT-I focuses on changing the behaviors and thoughts that interfere with restful sleep. This approach empowers individuals by providing them with tools and strategies, such as relaxation techniques and improved sleep hygiene, to manage their sleep issues independently. Researchers are excited about CBT-I because it offers a non-drug alternative that could lead to lasting improvements in sleep quality and overall well-being for people with mTBI.

What evidence suggests that CBT-I is effective for mTBI?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) can help people with mild traumatic brain injury (mTBI) who have trouble sleeping. Studies have found that CBT-I not only improves sleep quality but also reduces insomnia severity. For those with mTBI, CBT-I has been linked to improvements in anxiety, depression, and pain. This therapy also enhances participation in daily activities by improving sleep and mental function. These findings suggest that CBT-I could be a promising option for those facing sleep problems after a brain injury. Participants in this trial will receive CBT-I to evaluate its effectiveness in improving sleep and related outcomes for individuals with mTBI.12346

Are You a Good Fit for This Trial?

This trial is for individuals with mild traumatic brain injury (mTBI) who are experiencing sleep problems like insomnia. Participants should have a history of mTBI and currently struggle with sleep disturbances that affect their daily activities.

Inclusion Criteria

A score ≥ 10 on the Insomnia Severity Index (ISI)
Must speak, read, and write English
I have had a mild traumatic brain injury and sleep issues for over 4 weeks.

Exclusion Criteria

Generalized Anxiety Disorder-7 (GAD-7) score higher than 15 (severe anxiety symptoms)
Montreal Cognitive Assessment (MoCA) score less than 24
History of other neurological or psychological conditions
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (virtual)

Treatment

Participants receive cognitive behavioral therapy for insomnia (CBT-I) through six one-hour, weekly sessions delivered via Zoom

6 weeks
6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy for Insomnia (CBT-I)

Trial Overview

The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I) to see if it can improve sleep and reduce symptoms related to mTBI, as well as enhance the ability of participants to perform daily tasks.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: 15 mTBI cases who have sleep problems will receive CBT-IExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

Citations

Perspective: Cognitive Behavioral Therapy for Insomnia Is a ...

However, one recent study of CBT-I for patients with mild cognitive impairment (64) resulted in significant improvements in sleep and cognitive ...

The efficacy of cognitive behavioral therapy for sleep ...

Meta-analysis showing CBT clearly improves sleep after brain injury. •. Benefits cover subjective quality, insomnia severity and efficiency. •. In-person and ...

Internet-Guided Cognitive Behavioral Therapy for Insomnia ...

These results suggest that eCBT-I was more effective than sleep education in initially reducing self-reported insomnia, though the groups ...

0577 Cognitive Behavioral Therapy for Insomnia Improves ...

In individuals with TBI, CBT-I significantly improved key correlates of pain, including anxiety, depressive symptoms, and sleep quality.

Evaluation of Cognitive Behavioral Therapy for Insomnia ...

This study aims to evaluate how CBT-I can impact sleep, mTBI symptoms, and participants' functional performance. Official Title. Exploring ...

Assessing Cognitive Behavioral Therapy for Insomnia to ...

The main findings from this study (n=24) indicated that CBT- I improved insomnia symptoms and sleep quality and decreased dysfunctional beliefs ...