Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541886
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Comparative Efficacy of Standard vs Adapted CBT-I for Adolescents With Insomnia The DREAM-IT Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Efficacy of Standard vs Adapted CBT-I for Adolescents With Insomnia The DREAM-IT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 teens 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
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 teens 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
Detailed Description:
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 iteratively adapted through collaboration with stakeholders ie 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 and a standard ie not adapted CBT-I condition in adolescents with insomnia
Hypotheses
1 Each treatment Teen CBT-I and standard CBT-I will reduce insomnia symptoms compared to a no treatment waitlist condition
2 Neither treatment standard CBT-I and Teen CBT-I will be superior to the other in insomnia symptom reduction
3 Teen CBT-I will be more acceptable to teens and parents than standard CBT-I
Participants Adolescents with insomnia N42 and their parents will be randomized to either Teen CBT-I n14 standard CBT-I n14 or the waitlist control condition n 14
Recruitment 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 adolescents to complete
Interest Survey
The online survey 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
Invited teens and a parent or legal guardian will then meet with a research team member to further determine eligibility Importantly 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 three conditions using a randomization module in Research Electronic Data Capture 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 one of the treatment conditions standard CBT-I or Teen CBT-I will meet individually with a therapist for virtual sessions that will be up one-hour long Each session will be administered free of charge Most of each treatment session will be with just the therapist and the teen However a 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
Fidelity Monitoring Both 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 for that condition 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 Recordings will be delated after the 2-month follow up Only de-identified ie 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 conducted to assess pre- and post-intervention changes in clinical outcomes reporting effect sizes Cohens d and controlling for relevant covariates
Implementation outcomes will be reported descriptively With n42 comparing three groups in multiple pairwise comparisons 80 power and α 05 there is adequate statistical power to detect an effect size of d 100 which is consistent with prior research testing CBT-I for teens and adults with effect sizes ranging from d 100-122
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 concerns arise about the health and safety of a teen The teen and parent would be informed about this risk immediately and the risk would be reported to the necessary authorities to ensure safety Examples include if a teen reported abuse or endorsed suicidal or homicidal ideation
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 researchers 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 participants 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 inclusionexclusion criteria enrollment goal timeline and study interventions The adolescent participant will assent for the study following Institutional Review Board IRB guidelines along with obtaining consent from adult participants All participants will be asked to provide verbal consentassent 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
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 and a standard ie not adapted CBT-I condition in adolescents with insomnia
Hypotheses
1 Each treatment Teen CBT-I and standard CBT-I will reduce insomnia symptoms compared to a no treatment waitlist condition
2 Neither treatment standard CBT-I and Teen CBT-I will be superior to the other in insomnia symptom reduction
3 Teen CBT-I will be more acceptable to teens and parents than standard CBT-I
Participants Adolescents with insomnia N42 and their parents will be randomized to either Teen CBT-I n14 standard CBT-I n14 or the waitlist control condition n 14
Recruitment 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 adolescents to complete
Interest Survey
The online survey 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
Invited teens and a parent or legal guardian will then meet with a research team member to further determine eligibility Importantly 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 three conditions using a randomization module in Research Electronic Data Capture 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 one of the treatment conditions standard CBT-I or Teen CBT-I will meet individually with a therapist for virtual sessions that will be up one-hour long Each session will be administered free of charge Most of each treatment session will be with just the therapist and the teen However a 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
Fidelity Monitoring Both 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 for that condition 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 Recordings will be delated after the 2-month follow up Only de-identified ie 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 conducted to assess pre- and post-intervention changes in clinical outcomes reporting effect sizes Cohens d and controlling for relevant covariates
Implementation outcomes will be reported descriptively With n42 comparing three groups in multiple pairwise comparisons 80 power and α 05 there is adequate statistical power to detect an effect size of d 100 which is consistent with prior research testing CBT-I for teens and adults with effect sizes ranging from d 100-122
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 concerns arise about the health and safety of a teen The teen and parent would be informed about this risk immediately and the risk would be reported to the necessary authorities to ensure safety Examples include if a teen reported abuse or endorsed suicidal or homicidal ideation
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 researchers 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 participants 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 inclusionexclusion criteria enrollment goal timeline and study interventions The adolescent participant will assent for the study following Institutional Review Board IRB guidelines along with obtaining consent from adult participants All participants will be asked to provide verbal consentassent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None