Improving the Sleep of Cancer Patients Using an Internet-Based Program
NCT ID: NCT00716872
Last Updated: 2010-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2008-07-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ImmedSHUTi/ImmedHyp
In the first part of the trial, participants are assigned to the Immediate SHUTi group; that is, they receive access to the SHUTi program right away. In the second part of the trial (3 months later), participants are assigned to the Immediate Hypnosis group; that is, they receive access to the Hypnosis recordings right away.
Sleep Healthy Using the Internet (SHUTi)
SHUTi is an Internet program based on cognitive-behavioral therapy for insomnia (CBT-I). Users complete daily online sleep diaries in addition to receiving weekly access to six interactive "Cores" of information. As they progress through the program, users receive tailored instructions for how to improve their sleep.
Hypnosis recordings
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
ImmedSHUTi/DelayHyp
In the first part of the trial, participants are assigned to the Immediate SHUTi group; that is, they receive access to the SHUTi program right away. In the second part of the trial (3 months later), participants are assigned to the Delayed Hypnosis group; that is, they receive access to the Hypnosis recordings at the end of the study.
Sleep Healthy Using the Internet (SHUTi)
SHUTi is an Internet program based on cognitive-behavioral therapy for insomnia (CBT-I). Users complete daily online sleep diaries in addition to receiving weekly access to six interactive "Cores" of information. As they progress through the program, users receive tailored instructions for how to improve their sleep.
DelaySHUTi/ImmedHyp
In the first part of the trial, participants are assigned to the Delayed SHUTi group; that is, they receive access to the SHUTi program at the end of the study. In the second part of the trial (3 months later), participants are assigned to the Immediate Hypnosis group; that is, they receive access to the Hypnosis recordings right away.
Hypnosis recordings
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
DelaySHUTi/DelayHyp
In the first part of the trial, participants are assigned to the Delayed SHUTi group; that is, they receive access to the SHUTi program at the end of the study. In the second part of the trial (3 months later), participants are assigned to the Delayed Hypnosis group; that is, they receive access to the Hypnosis recordings at the end of the study.
No interventions assigned to this group
Interventions
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Sleep Healthy Using the Internet (SHUTi)
SHUTi is an Internet program based on cognitive-behavioral therapy for insomnia (CBT-I). Users complete daily online sleep diaries in addition to receiving weekly access to six interactive "Cores" of information. As they progress through the program, users receive tailored instructions for how to improve their sleep.
Hypnosis recordings
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
Eligibility Criteria
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Inclusion Criteria
* 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 treatment
Exclusion Criteria
* 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 months
21 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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University of Virginia
Principal Investigators
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Lee M Ritterband, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Lora D Baum, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Elaine T Bailey, Ph.D.
Role: STUDY_DIRECTOR
University of Virginia
Locations
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University of Virginia Department of Psychiatry & Neurobehavioral Sciences
Charlottesville, Virginia, United States
Countries
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References
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Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96. doi: 10.1200/JCO.2005.09.548.
Other Identifiers
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13685
Identifier Type: -
Identifier Source: org_study_id
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