Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study

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:

1. Teen CBT-I will reduce insomnia symptoms compared to a no treatment (waitlist) condition.
2. 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).

Recruitment: Parents of adolescents are recruited primarily via social media. Recruitment posts and images are boosted to both Facebook and Instagram using the Facebook Ads Manager system. We also advertise our study on Research Match and All IN for Health TrialX iConnect.

ResearchMatch.org is a national electronic, web-based recruitment tool that was created through the Clinical \& Translational Science Awards Consortium in 2009 and is maintained at Vanderbilt University Medical Center. There is no cost for researchers at participating institutions in the ResearchMatch Network to use ResearchMatch for the purposes of conducting recruitment feasibility analysis or participant recruitment. The Vanderbilt University Medical Center IRB provides oversight for ResearchMatch as a recruitment tool.

iConnect is a HIPAA-compliant and secure public facing research recruitment platform provided by the Indiana Clinical and Translational Sciences Institute (Indiana University) consisting of a study trial listing and volunteer registry. This system is licensed by Indiana University from TrialX and is monitored by the Indiana University Information Technology Services (UITS) and University Information Security Office (ISO). Study Teams have access to their study listings and participant referrals based on a secure login. There is a small Administrative Team within the Indiana CTSI that manages the iConnect platform and has access to all study information, referrals, and registry volunteers. This online platform provides researchers with the ability to create a public facing webpage that can contain a brief prescreener and the ability for the public to refer themselves to the trial.

Across social media, research match, and All in for Health, recruitment posts and images describe the study and provide a link to an Interest Survey for parents to complete. Parents can then provide consent and contact information for their teen to also be contacted and invited to complete a recruitment survey.

Interest Survey:

The online surveys will provide additional information about the study and ask eligibility questions. Ineligible respondents will be informed of their status and will not be asked for any additional information. Respondents who are not ineligible* will be asked for contact information and demographic information.

Some, but not all, interested participants will be contacted and invited to complete the next step, an Eligibility and Consent Meeting.

*Some eligibility criteria will be assessed during the Eligibility and Consent meeting as they are more complex and require evaluation through an interactive call rather than a survey.

Eligibility and Consent Meeting:

Parent-teen dyads who completed the recruitment surveys and are not screened out will then be asked to meet with a research team member to further determine eligibility. Teen suicidal ideation will be evaluated, along with other comorbid conditions that may make the teen ineligible.

If the teen and parent are determined to be eligible for the study, an informed consent process will then be initiated. Parents and teens will be provided with more information about the study and the opportunity to ask questions, prior to deciding whether or not they would like to be part of the study. Enrolled participants will then proceed to the baseline assessment.

Randomization Once the baseline measures are completed, the teen-parent dyad will be randomized to one of the two conditions using a randomization module in REDCap. Randomization will be stratified based on age so that there is the same number of younger teens (ages 13-15) and older teens (ages 16-18) in each condition.

Conditions Participants randomized to Teen CBT-I will meet individually with a therapist for a virtual, one-hour session. Each session will be administered free of charge. Most of each treatment session will be with just the therapist and the teen. However, the parent will be asked to join for the last ten minutes of each appointment to keep the parent informed about the treatment plan. If they wish, teens can decide to involve their parent earlier in the session.

Teen CBT-I Teens in this treatment condition will have an intake session and between 4 to 6 treatment sessions. 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 from the teen's hang out space. The last session will be centered on maintenance of treatment gains. Treatment will include visual aids (e.g., a powerpoint) to convey didactic or psychoeducational material.

Waitlist Control Teens in the waitlist condition will still complete the same study measures, 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 completing the baseline measures). 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.

Fidelity Monitoring Audio and video will be recorded during the treatment sessions. The purpose of this is so that supervisors can review some of the sessions to help with therapist training, and to make sure that the therapist is following the treatment protocol. These recordings will only be reviewed by the study team to monitor the therapist, and recordings will be stored securely. No one outside of the study will have access to these recordings. The recordings will be deleted after the 2-month follow up. De-identified (i.e., without names, location) transcripts of the sessions will be kept. If a teen-parent dyad is not comfortable with recording of the sessions, they can opt out, meaning that they can still be in the study, but their treatment sessions will not be recorded. There is an opt-in / opt-out component within the informed consent process.

Analysis Plan Linear regression modeling will be used to assess pre- and post-intervention changes in clinical outcomes, reporting effect sizes (Cohen's d) and controlling for relevant covariates.

Implementation outcomes will be reported descriptively. With n=28 (comparing two groups in multiple pairwise comparisons), 80% power, and α = .05, there is adequate power to detect an effect size of d = 1.00, which is consistent with prior research testing CBT-I for teens and adults, with effect sizes ranging from d = 1.00-1.22.

Potential Risks Potential risks include confidentiality breaches and discomfort from wearing the actigraph, a wrist-watch like device that will be used to measure adolescent sleep outcomes.

The risk of loss of confidentiality will be minimized by the research team. Efforts will be made to keep personal information confidential, and only de-identified group data will be shared or published to keep participant identity confidential. Personal information would only be disclosed if required by law.

Completed questionnaires will be stored in a secure, electronic database that is accessible only by study team members approved by the Office for Protection of Human Subjects.

One exception to confidentiality would be if there is concern about the health and safety of a teen. This risk would be immediately discussed with the teen and parent and reported to the necessary authorities to ensure safety. An example of this would be if a teen indicated they were being abused or that they were planning to hurt themselves or someone else.

Another exception to confidentiality is that the university and federal offices that are in charge of protecting the rights of research participants and the quality of research may, in rare instances, need to inspect or copy a researcher's data. This includes the Indiana University Institutional Review Board and the Office for Human Research Protections.

Although extremely rare, if a participant experiences skin discomfort from the actigraph, they can wear the device over a shirt.

It is also possible that participants could lose or damage the actigraph. Research staff will explain the proper use and importance of these devices to prevent such risks, but the risk is still possible. If a participant loses or damages the actigraph, they will not be held financially responsible and will not be excluded from the study. Data within the actigraph can only be accessed with specialized software. In addition, no identifiers are included in the actigraphic output aside from the participant's research ID.

Informed consent. The process will be conducted in a location that is considered private and controlled. The consenting process will include the study purpose, inclusion/exclusion criteria, enrollment goal, timeline and study interventions. The adolescent participant will assent for the study following IRB guidelines along with obtaining consent from adult participants. All participants will be asked to provide verbal consent/assent prior to participation in any study activities or interventions.

Potential benefits of the proposed research to human subjects and others Benefits to participants may include improvement in insomnia symptoms. The potential benefit to society is determining whether the adapted treatment protocol is efficacious. If it is, it can then be used more widely to improve outcomes for adolescents with insomnia. This can lead to improved functioning in adolescents with insomnia and intervention success for providers and caregivers.