Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorIndiana University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents (13-18 years) who are in either middle school or high school and meet ICSD-3 diagnostic criteria for Chronic Insomnia Disorder, currently or in the past year, based on self-reported insomnia symptoms, using a screening checklist.
Reside in a state where Dr. McQuillan (supervising provider) is licensed to practice psychology (with PsyPact) which are the following states: Alabama, Arizona, Arkansas, Colorado, Commonwealth of the Northern Mariana Islands, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
Sufficient English language proficiency for consent and study participation
Reliable internet access to attend virtual visits with audio and video
Disqualifiers
Sleep aid use that is either inconsistent (e.g., used some but not all nights) and cannot be discontinued OR consistent and effective enough that the teen no longer has insomnia symptoms while using it. If a teen agrees to keep the dose and frequency of sleep aid use consistent throughout the treatment and still has insomnia symptoms at baseline, they are not ineligible.
Prior participation in Aim 1 of DREAM IT study (e.g., participation in an Aim 1 focus group).
Comorbid medical or psychiatric conditions, including substance use disorders, that are acute, unstable, or untreated. Individuals with Autism Spectrum Disorder, Epilepsy, Schizophrenia, and Bipolar Disorder will be excluded.
Comorbid delayed sleep wake phase disorder or other active/untreated sleep disorders, including RLS, OSA, and Nightmare disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Insomnia (CBT-I)
BehavioralCBT-I was developed as a treatment for adults with insomnia. There are more than 100 studies showing that CBT-I is effective in treating insomnia in adults, and several studies suggest it is also effective in treating insomnia in teens.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Teen CBT-IExperimental treatment 1 intervention
Group B: WaitlistNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Teen-reported insomnia severity
assessed via the PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance scale, which has been established as reliable and valid with adolescents. Possible scores on this scale range from 10 - 50, where higher scores reflect more severe insomnia.
Time frame
Baseline, Post-treatment (approximately 8 weeks after baseline), and 2 month follow up2
Teen-reported treatment acceptability
based on the widely used Client Satisfaction Questionnaire, which assesses treatment feasibility, satisfaction, and perceived helpfulness. Possible scores on this scale range from 8-40, where higher scores reflect higher acceptability ratings.
Time frame
Post-treatment (approximately 8 weeks after baseline)Secondary outcomes
1
Teen-reported sleep onset latency
Based on sleep diary
Time frame
Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up2
Teen-reported wake after sleep onset
Based on sleep diary
Time frame
assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up3
Teen-reported night wakings
Number of night wakings, based on sleep diary
Time frame
assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up4
Teen-reported sleep efficiency
Average of total sleep time divided by time spent in bed each night, based on information provided by teen in the sleep diary
Time frame
assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
American Academy of Sleep Medicine
Collaborator
Nyxeos Consulting
Collaborator
Source ClinicalTrials.gov