Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: SHUTi

• Registration Number: NCT03279055
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study is evaluating a six-session online program designed to help insomnia (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.

Detailed Description

The purpose of this study is to learn whether an adapted version of SHUTi (Sleep Healthy Using the Internet), a six-session online program which has been found to be effective in other groups of people, will be useful in treating insomnia in adolescent and young adult cancer survivors.

Study Timeline

• Study First Submitted: 2017-09-09
• Study First Submitted QC: 2017-09-09
• Study First Posted: 2017-09-12
• Study Start: 2018-08-10
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 14-25 years of age
• History of a cancer diagnosis
• No active cancer therapy (excluding chemoprevention) in the past three months, and no cancer therapy currently planned in the next 6 months
• No surgery planned in the next 6 months
• Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
• Able to read and write in English
• Has internet access at home
• Motivated and able to follow the demands of the SHUTi program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep

Exclusion Criteria

• Prior attempt(s) to treat insomnia using cognitive-behavioral treatment for insomnia
• History of Bipolar Disorder diagnosis
• History of a Seizure Disorder diagnosis or have experienced a seizure in the past 12 months
• Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the study period
• Diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has not been unevaluated, or other sleep disorder
• Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
• Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHUTi	SHUTi	* Participants will be provided with an individual access code for SHUTi * SHUTi is delivered over 6 sessions, each taking 20-30 minutes * SHUTi is delivered by a virtual therapist * Participants will learn about the etiology and maintenance of their insomnia * Participants will learn how to maintain their sleep log * Participants will learn how to address lifestyle barriers that impact their sleep * Participants will be taught stimulus control techniques targeting non-sleep behaviors in the bedroom * Participants will learn a range of cognitive techniques that address the key cognitive factors that perpetuate poor sleep behavior * Participants will be taught how to gradually expand their restricted sleep

Primary Outcome Measures

Name	Time	Method
Insomnia symptoms	8 weeks	Insomnia symptom severity will be assessed using the Insomnia Severity Index

Secondary Outcome Measures

Name	Time	Method
Daytime sleepiness	8 weeks	Measured with Pediatric Daytime Sleepiness Scale
Quality of life	8 weeks	Measured with PedsQL
Sleep efficiency	6 weeks	Sleep diary calculated sleep efficiency

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States