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).
Recruitment: Parents of adolescents will be recruited via social media. Recruitment posts
and images will be boosted to both Facebook and Instagram using the Facebook Ads Manager
system. Recruitment posts and images will briefly 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.