Comparative Efficacy of Standard vs. Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
NCT Number: NCT06541886
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Insomnia
Interventions: BEHAVIORAL: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsor: Indiana University
Collaborators: American Academy of Sleep Medicine|Nyxeos Consulting
Sex: ALL
Age: CHILD, ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

Summary:
The goal of this study is to test two treatments for teen insomnia, comparing the treatments to each other and to a waitlist condition. One treatment is called Cognitive Behavioral Therapy for Insomnia (CBT-I). This treatment was developed for adults but is sometimes also used for teens. The second treatment is a new version of CBT-I that was adapted for and with teens, called Teen CBT-I. To create Teen CBT-I, teens, parents, and health care providers provided feedback about standard CBT-I in an iterative adaptation process. 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? Researchers will compare Teen CBT-I to the waitlist control condition to see if insomnia symptoms significantly improve in the treatment group.
* Does Teen CBT-I work as well as CBT-I in improving insomnia symptoms? Researchers will compare Teen CBT-I and standard CBT-I to see if insomnia symptoms improve more for one treatment than for the other.
* Do teens and their parents prefer one treatment over the other? Researchers will compare Teen CBT-I and standard CBT-I to see if acceptability ratings are better for one treatment compared to the other.

Teen CBT-I is expected to improve teen insomnia symptoms just as well as standard CBT-I. However, Teen CBT-I is expected to be more acceptable to teens and parents than standard CBT-I.

Teen participants will be randomized to one of the three conditions: standard CBT-I treatment, 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:

* Standard CBT-I, which involves an intake session and 6 treatment sessions, each of which will be up to one-hour, individual virtual sessions with a therapist. 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.
* Teen CBT-I also includes an intake session and 6 treatment sessions that will be up to one-hour, individual, virtual sessions with a therapist. It includes similar content to CBT-I with some small changes to match teen biology and lifestyles.
* 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.

Primary Outcome Measures: 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., Baseline, Post-treatment (approximately 8 weeks after baseline), and 2 month follow up|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., Post-treatment (approximately 8 weeks after baseline)
Secondary Outcome Measures: Teen-reported sleep onset latency, Based on sleep diary, Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Teen-reported wake after sleep onset, Based on sleep diary, assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Teen-reported night wakings, Number of night wakings, based on sleep diary, assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|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, assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Sleep efficiency, Average of total sleep time divided by time spent in bed each night, as measured via the actigraph, assessed at Baseline and Post-treatment (approximately 8 weeks after baseline)|Wake after sleep onset, Based on actigraphy, assessed at Baseline and post-treatment (approximately 8 weeks after baseline)|Teen Mood, Depressive Symptoms from the PROMIS (Patient-Reported Outcomes Measurement Information System) measure. Possible scores range from 8 to 40, where higher scores reflect more depressive symptoms., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Teen Stress, Teen report on the PROMIS (Patient-Reported Outcomes Measurement Information System) Psychological Stress Experiences measure. Possible scores range from 8 to 40, where higher scores reflect more stress., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Teen Daytime Sleepiness, Teen report on the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment Scale. Possible scores range from 8 to 40, where higher scores reflect more daytime impairment., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Teen-reported sleep hygiene, pediatric sleep practices questionnaire - short form. Possible scores range from 7 to 35, where higher scores reflect better sleep hygiene., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Teen-reported parent-teen conflict about sleep, "How much did you and your parent argue about sleep in the past week ?" Using a 1-5 Likert scale, where higher scores reflect more conflict., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Parent-reported parent-teen conflict about sleep, "How much did you and your teen argue about sleep in the past week ?" Using a 1-5 Likert scale, where higher scores reflect more conflict., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Parent-reported insomnia symptoms, using the parent-report PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance scale. Possible scores range from 10 - 50, where higher scores reflect more severe insomnia., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Parent-reported daytime sleepiness, using the parent-report PROMIS (Patient-Reported Outcomes Measurement Information System) sleep related impairment scale. Possible scores range from 8 to 40, where higher scores reflect more severe daytime impairment., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Parent perception of adolescent mood, using the parent-report PROMIS (Patient-Reported Outcomes Measurement Information System) depressive symptoms scale. Possible scores range from 6 to 30, where higher scores reflect more teen depressive symptoms., assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Parent-reported school attendance, Based on two items: "In the past 2 weeks, how many days has your child missed school because of difficulty sleeping?" AND "In the past 2 weeks, how many days has your child been late to school because of difficulty sleeping?", assessed at Baseline, Post-treatment (approximately 8 weeks after baseline), and at 2-month follow up|Teen-reported treatment adherence, via adolescent report on sleep diary, assessed at Post-treatment (approximately 8 weeks after baseline) and at 2-month follow up|Treatment engagement, based on session attendance and treatment completion, assessed at post-treatment approximately 8 weeks after baseline|Adverse treatment effects, Report of any car accidents, suicidality, or risky behaviors that could be attributed to sleep restriction and/or reductions in daytime alertness, assessed at post-treatment approximately 8 weeks after baseline|Parent-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., assessed at post-treatment approximately 8 weeks after baseline