Cognitive Behavioral Therapy for Insomnia

Overseen By Sarah M Honaker, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Sleep aids

Disqualifiers: Substance use, Autism, other disorders

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a tailored version of Cognitive Behavioral Therapy for Insomnia (CBT-I) benefits teens with insomnia. The adapted treatment, called Teen CBT-I, aligns with teen lifestyles and biology. Participants will either receive the Teen CBT-I treatment or join a waitlist and later access an app for insomnia treatment. Teens who have experienced insomnia symptoms in the past year and reside in certain states are suitable candidates for this trial. The study will evaluate improvements in sleep and assess whether teens and their parents find the therapy acceptable. As an unphased trial, this study provides a unique opportunity for teens to access innovative treatment tailored to their needs.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you use sleep aids inconsistently or if they effectively eliminate your insomnia symptoms, you may not be eligible. If you agree to keep the dose and frequency of sleep aid use consistent and still have insomnia symptoms, you can participate.

What prior data suggests that Teen CBT-I is safe for teens?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) safely improves sleep in teens. Studies have found that CBT-I helps teens sleep longer and more soundly without medication. This therapy teaches good sleep habits, establishes a regular sleep schedule, and changes negative thoughts about sleep. Many studies with teens support these benefits. No serious side effects have been reported, making it a well-tolerated option. Teens can safely try CBT-I to see if it helps with their insomnia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) for teens because it offers a personalized virtual treatment option that combines the convenience of online sessions with the expertise of a live therapist. Unlike standard insomnia treatments that might rely on medication or generic advice, this approach tailors techniques like Healthy Sleep Habits and Setting a Sleep Schedule specifically for teens. Additionally, it uses visual aids to effectively communicate complex ideas about sleep, making it accessible and engaging for younger audiences. Plus, the waitlist group will later gain access to a guided app-based treatment, offering flexibility and the potential to reach more teens with insomnia.

What evidence suggests that Teen CBT-I might be an effective treatment for teen insomnia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep problems in teens. In this trial, some teens will receive Teen CBT-I, which includes an intake session and six virtual treatment sessions with a therapist. Studies have found that CBT-I helps teens fall asleep faster and sleep better overall. Specifically, teens who tried CBT-I slept longer and spent more time actually sleeping when in bed. Additionally, CBT-I can be conducted in various settings, making it more accessible for teens with sleep issues. Overall, evidence suggests that CBT-I is a promising method for helping teens with insomnia. ^{2 4 6 7 8}

Who Is on the Research Team?

Sarah M Honaker, PhD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for teens aged 13-18 with chronic insomnia, based on self-reported symptoms. They must have reliable internet to attend virtual sessions and live in states where Dr. McQuillan is licensed. A parent living with the teen at least half the time must participate in parts of the therapy.

Inclusion Criteria

I can speak and understand English well enough for medical consent and study participation.

I am a teenager with chronic insomnia diagnosed in the last year.

I live in a state where Dr. McQuillan is licensed to practice.

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 Teen CBT-I treatment, including 4-6 one-hour individual virtual sessions with a therapist

8 weeks

4-6 visits (virtual)

Waitlist Control

Participants in the waitlist control do not receive treatment for 8 weeks but complete study measures

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Teen CBT-I

Trial Overview The study tests Teen CBT-I, an adapted Cognitive Behavioral Therapy for Insomnia, against a waitlist control group. Teens will receive individual virtual therapy sessions focused on improving sleep habits and managing thoughts about sleep.

How Is the Trial Designed?

Group I: Teen CBT-I Experimental Treatment 1 Intervention

Teens in this treatment condition will have an intake session and 6 treatment sessions virtually and individually with a therapist. The first session will include an introduction to Sleep Science and Insomnia Treatment. Middle sessions will include Healthy Sleep Habits, Setting a Sleep Schedule, Preparing the Mind and Body for Sleep, and Distinguishing the Sleep Space and Wake Space. The final session will be be centered on maintenance of treatment gains. Treatment will also include visual aids (e.g., slides) to convey didactic or psychoeducational material.

Group II: Waitlist Active Control 1 Intervention

Teens in the waitlist condition will still complete the same study measures and receive the same payment for taking part in the study, but they will not receive treatment from a therapist. Their treatment will begin after they have completed the second round of measures (i.e., 8 weeks after they complete the baseline assessment). After they have completed the second round of measures, they will be given free access to an app that provides guided insomnia treatment. While no live therapist is involved, the approach is similar to traditional CBT-I.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Nyxeos Consulting

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Online Cognitive Behavior Therapy for Insomnia (CBTI) significantly improved sleep efficiency and reduced insomnia symptoms in adolescents, with most participants reaching subclinical levels of insomnia after treatment.

The treatment also positively impacted cognitive functioning, particularly in areas like visuospatial processing and phonological working memory, suggesting that better sleep can enhance cognitive abilities in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of online insomnia treatment on executive functions in adolescents. de Bruin, EJ., Dewald-Kaufmann, JF., Oort, FJ., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39628800/

The efficacy of cognitive behavioral therapy for insomnia in ... CBT-I was effective in improving insomnia in adolescents and some sleep-related outcomes, including sleep onset latency, total sleep time, and sleep efficiency.

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1413694/full

The efficacy of cognitive behavioral therapy for insomnia in ... CBT-I was effective in improving insomnia in adolescents and some sleep-related outcomes, including sleep onset latency, total sleep time, and sleep efficiency.

3. acamh.org acamh.org/blog/teen-insomnia/

Cognitive Behavioral Therapy for Insomnia in Teens New evidence shows CBT-I significantly improves both insomnia symptoms and sleep quality in adolescents.

4. sleeplessinarizona.com sleeplessinarizona.com/cognitive-behavioral-therapy-for-insomnia-works-for-teens-2024-study-confirms/

Cognitive Behavioral Therapy for Insomnia Works ... How Did CBT-I Improve Teen Insomnia? · 1. Insomnia Severity Dropped Significantly · 2. Teens Fell Asleep Faster · 3. Total Sleep Time Increased · 4.

5. tandfonline.com tandfonline.com/doi/full/10.1080/15402002.2025.2529856

Evaluating the Effectiveness of Cognitive Behavioral ... Delivering Cognitive Behavioral Therapy for insomnia (CBT-I) in schools may be an effective way to reach adolescents with poor sleep. This ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11613502/

The efficacy of cognitive behavioral therapy for insomnia in ... CBT-I was effective in improving insomnia in adolescents and some sleep-related outcomes, including sleep onset latency, total sleep time, and sleep efficiency.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06541886

Adapted CBT-I for Adolescents With Insomnia : The ... Teen CBT-I includes 4-6 one-hour individual virtual sessions with a therapist. It includes standard CBT-I content with some small changes to match teen biology ...

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6490

A Single Arm Pilot Trial of Brief Cognitive Behavioral Therapy ... There have been a handful of randomized controlled trials of CBT-I in children and adolescents, showing benefit on improving sleep outcomes. However ...