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

Trial Summary

What is the purpose of this trial?

The goal of this study is to test an adapted treatment for teen insomnia in comparison to a waitlist condition. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an intervention that was developed for adults and is sometimes also used for teens. Teens, parents, and health care providers helped to review and adapt CBT-I to form Teen CBT-I. Teen CBT-I includes most of the same content as CBT-I, with some changes to match teen biology and lifestyles. The main questions this clinical trial aims to answer are: * Does Teen CBT-I improve insomnia symptoms in teens? o Researchers will compare Teen CBT-I to the waitlist control condition to see if insomnia symptoms significantly improve in the treatment group. * Do teens and their parents find Teen CBT-I to be acceptable? o Researchers will examine Teen CBT-I acceptability ratings. Teen CBT-I is hypothesized to improve insomnia symptoms in teens, and teens and parents are hypothesized to find Teen CBT-I to be acceptable. Teen participants will be randomized to one of the two conditions: Teen CBT-I treatment or waitlist control. They will also complete assessments at three timepoints: Baseline (before treatment); post-intervention (after treatment); and follow-up (2 months after treatment). For each assessment, teen participants will: * Fill out questionnaires about their sleep, mood, and other areas * Keep daily sleep logs for one week * Wear an actigraph, a wrist-watch like device that records activity levels to determine sleep-wake patterns, for one week. Parent participants will also be asked to complete questionnaires at each measurement point about their teen's sleep, mood, and other areas. The intervention conditions are: * 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 and lifestyles. The main parts of this treatment include healthy sleep habits, only using the bed for sleep, keeping a recommended sleep schedule, changing negative thoughts about sleep, and learning ways to relax the mind and body for sleep. * Waitlist-control, in which teens will not receive any treatment for 8 weeks. After the second assessment, they will receive free access to an app-based CBT-I treatment which they can complete on their own.

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 data supports the effectiveness of the treatment Teen CBT-I for insomnia in adolescents?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for adolescents, with significant improvements in sleep onset, sleep efficiency, and insomnia symptoms. Studies also indicate that CBT-I can help reduce psychiatric symptoms like depression and anxiety in adolescents with insomnia. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia safe for adolescents?

Research on Cognitive Behavioral Therapy for Insomnia (CBT-I) in adolescents suggests it is generally safe, with studies focusing on its effectiveness and feasibility without reporting significant safety concerns. ^{1 2 3 4 6}

How is Teen CBT-I different from other treatments for insomnia in adolescents?

Teen CBT-I is unique because it can be delivered both online and in group settings, making it more accessible for adolescents who may be reluctant to seek help. It focuses on changing thoughts and behaviors related to sleep, and has shown significant improvements in sleep patterns and efficiency, even in those with mental health issues. ^{1 2 3 4 7}

Research Team

Sarah M Honaker, PhD

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Differential effects of online insomnia treatment on executive functions in adolescents. [2018]

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

Efficacy of internet and group-administered cognitive behavioral therapy for insomnia in adolescents: a pilot study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavioral therapy for adolescents with insomnia: Feasibility and preliminary efficacy. [2023]

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

Internet-delivered cognitive behaviour therapy for adolescents with insomnia comorbid to psychiatric conditions: A non-randomised trial. [2021]

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

A brief behavioral treatment for unresolved insomnia in adolescents: a single-case multiple baseline pilot study, evaluating self-reported outcomes of efficacy, safety, and acceptability. [2023]

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

Digital Cognitive Behavioral Therapy for Insomnia for Adolescents With Mental Health Problems: Feasibility Open Trial. [2020]