Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Teen-reported insomnia severity
研究概览
简要总结
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.
详细描述
Background: Cognitive Behavioral Therapy for Insomnia (CBT-I) has been well-established as an efficacious and first-line treatment for insomnia in adults, but research on its use with adolescents is limited. Preliminary evidence for the efficacy of CBT-I with adolescents is promising, but treatment protocols in existing trials are heterogeneous, making it difficult to characterize CBT-I for teens. In Aim 1 of this study, CBT-I was systematically adapted through collaboration with stakeholders (i.e., teens, parents, and behavioral sleep medicine providers across the country), making changes to the intervention tailored to teen biology and lifestyles.
Objective: The objective of this study is to test this adapted intervention (hereafter referred to as Teen CBT-I) in comparison to a waitlist control condition in adolescents with insomnia.
Hypotheses:
- Teen CBT-I will reduce insomnia symptoms compared to a no treatment (waitlist) condition.
- Teen CBT-I will be deemed acceptable by teens and parents.
Participants: Adolescents with insomnia (N=28) and their parents will be randomized to either Teen CBT-I (n=14) or the waitlist control condition (n = 14).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant)
盲法说明
Participants assigned to either condition will know about their assignment as they either will or will not receive treatment with a therapist during the 8-week active treatment period. Care providers, investigators, and outcome assessors will also be aware of group assignment.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Parents or other caregivers of these adolescents (hereafter referred to as a parent) must live in the home with the identified adolescent at least 50% of the time and must report playing a parental role for that adolescent. The parent must also be able to attend the final 10 minutes of each treatment session, if the teen is randomized to a treatment condition.
排除标准
- •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
- •Active suicidal ideation with plan and intent
研究组 & 干预措施
Teen CBT-I
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.
干预措施: Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
Waitlist
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.
结局指标
主要结局
Teen-reported insomnia severity
时间窗: Baseline, Post-treatment (approximately 8 weeks after baseline), and 2 month follow up
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.
Teen-reported treatment acceptability
时间窗: Post-treatment (approximately 8 weeks after baseline)
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.
次要结局
- Teen-reported sleep onset latency(Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Sleep efficiency(assessed at Baseline and Post-treatment (approximately 8 weeks after baseline))
- Wake after sleep onset(assessed at Baseline and post-treatment (approximately 8 weeks after baseline))
- Teen Stress(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen-reported wake after sleep onset(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen-reported night wakings(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen-reported sleep efficiency(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen Mood(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen-reported sleep hygiene(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen Daytime Sleepiness(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen-reported parent-teen conflict about sleep(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Parent-reported parent-teen conflict about sleep(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Parent-reported insomnia symptoms(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Parent-reported daytime sleepiness(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Parent perception of adolescent mood(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Parent-reported school attendance(assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up)
- Teen-reported treatment adherence(assessed at Post-treatment (approximately 8 weeks after baseline) and at 2-month follow up)
- Treatment engagement(assessed at post-treatment approximately 8 weeks after baseline)
- Adverse treatment effects(assessed at post-treatment approximately 8 weeks after baseline)
- Parent-reported treatment acceptability(assessed at post-treatment approximately 8 weeks after baseline)
研究者
Sarah Honaker
Associate Professor of Pediatrics
Indiana University