Status:

COMPLETED

The Better Sleep for Supporters With Insomnia Study

Lead Sponsor:

University of Virginia

Conditions:

Family Caregivers

Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Intern...

Detailed Description

Insomnia is a significant public health problem with substantial medical, psychological and financial ramifications. About 50-75% of the 3.5 million Americans who provide unpaid medical, practical, an...

Eligibility Criteria

Inclusion

  • self-report providing unpaid care (e.g., practical, medical, and/or emotional support) to an adult family member or "family-like" close individual who is either currently undergoing any anti-cancer treatment (e.g., surgery, chemotherapy, radiation, for either curative or palliative intent) or has completed anti-cancer treatment within the past 2 years.
  • Insomnia severity index score of 10 or higher
  • age 18 and over
  • regular access (at least 2/week) and willingness to use a computer and the Internet and check email
  • ability to read and speak English
  • resident of the US

Exclusion

  • irregular sleep schedules that prevent the ability to follow intervention recommendations (i.e., with usual bedtimes outside of 8:00pm to 2:00am or arising time outside of 4:00am to 10:00am)
  • current psychological treatment for insomnia
  • screen positive for a history of psychotic or bipolar disorder; and current severe depression, high risk of suicide, substance use (alcohol, drug) disorder within the past year
  • symptoms suggestive of untreated sleep disorders other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder)
  • presence of uncontrolled medical condition that is deemed to interfere with the study procedures, or put the study participant at undue risk
  • Unstable medication regimen (change to schedule or dosage within past 3 months) for a prescription medication regimen thought to impact sleep.

Key Trial Info

Start Date :

September 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2022

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT04661306

Start Date

September 30 2020

End Date

January 31 2022

Last Update

May 17 2022

Active Locations (1)

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1

University of Virginia

Charlottesville, Virginia, United States, 22903