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Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

21 Years
Not Enrolling
Cancer, Insomnia

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Trial Information

Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

The purpose of this study is to test the feasibility of using an Internet program to improve
the sleep of cancer patients with insomnia. Participants will receive access to the
Internet program (called SHUTi, or "Shut-Eye") as well as to self-hypnosis recordings
designed to improve sleep. SHUTi provides an online, tailored educational program to
individuals who are experiencing sleep difficulties, including those having difficulty
falling asleep, waking in the middle of the night, and waking too early in the morning.

Inclusion Criteria:

- Age = At least 21 years old

- Regular access to the Internet, including e-mail

- Cancer patient

- Any type of cancer (EXCEPT non-melanoma skin cancer)

- In remission from any stage of cancer (active treatment completed at least one
month prior to enrollment)

- Insomnia diagnosis (combined from DSM-IV and ICSD):

- Subjective complaints of poor sleep for at least 6 months

- Sleep difficulties ≥3 nights/week

- Difficulty falling asleep (≥30 minutes to fall asleep) OR

- Difficulty staying asleep (≥30 minutes awake in the middle of the night)

- ≤6.5 hours sleep/night

- Poor sleep causes marked distress or significant impairment in daytime
functioning (e.g. fatigue, performance deficits, mood disturbance)

- Participant feels that the insomnia was caused/aggravated by cancer or cancer

Exclusion Criteria:

- Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy,

- Having a medical condition other than cancer that causes insomnia

- Experiencing a psychiatric disturbance (major depression, psychosis)

- Experiencing substance abuse

- Currently undergoing psychotherapy or counseling

- Changing sleep/anxiety/depression medication within the past month

- Having an "unusual" sleep pattern

- Normal bedtime is after 2am OR

- Normal wake time is after 9am

- Working as a shift worker (that is, having a schedule that requires working through
the night)

- Participants reports that she is pregnant or intending to get pregnant in the next 4

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Insomnia Severity Index (ISI)

Outcome Time Frame:

prior to intervention, after SHUTi use, after Hypnosis use

Safety Issue:


Principal Investigator

Lee M Ritterband, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

November 2009

Related Keywords:

  • Cancer
  • Insomnia
  • cancer
  • sleep
  • insomnia
  • Internet
  • SHUTi
  • Sleep Initiation and Maintenance Disorders



University of Virginia Department of Psychiatry & Neurobehavioral SciencesCharlottesville, Virginia  22908