NCT04661306

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 Internet) for cancer caregivers. Participating caregivers' sleep and sleep-related characteristics will be characterized from a baseline assessment; then, caregivers will receive complementary and voluntary access to SHUTi. Among caregivers who choose to use SHUTi, intervention use, perceived appropriateness, and effects on sleep and quality of life will be assessed. Among caregivers who choose not to use SHUTi, reasons and barriers to using the intervention will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

October 28, 2020

Last Update Submit

May 16, 2022

Conditions

Family CaregiversCancerInsomniaSleep Initiation and Maintenance Disorders

Keywords

Family CaregiversCancerInsomnia

Outcome Measures

Primary Outcomes (1)

  • SHUTi Usage

    Number of SHUTi Cores completed by participants

    9 weeks

Secondary Outcomes (22)

  • Insomnia severity

    Baseline, 9 weeks

  • Sleep onset latency (SOL)

    Baseline, 9 weeks

  • Wake after sleep onset (WASO)

    Baseline, 9 weeks

  • Perceived sleep quality

    Baseline, 9 weeks

  • Sleep-related cognitions

    Baseline, 9 weeks

  • +17 more secondary outcomes

Study Arms (1)

SHUTi

EXPERIMENTAL
Behavioral: SHUTi (Sleep Healthy Using the Internet)

Interventions

SHUTi (Sleep Healthy Using the Internet)BEHAVIORAL

Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program

Also known as: CBTi
SHUTi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (2)

  • Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249.

    PMID: 27902836BACKGROUND

  • Shaffer KM, Garland SN, Mao JJ, Applebaum AJ. Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. J Psychother Integr. 2018 Sep;28(3):275-291. doi: 10.1037/int0000105.

    PMID: 30245560BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Kelly Shaffer, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2020

First Posted

December 10, 2020

Study Start

September 30, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

US(1)