An interventional study of Sleep Healthy Using the Internet (SHUTi) and Hypnosis recordings in Cancer and Insomnia, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2010-02-25.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether an Internet-based program, Sleep Healthy Using the Internet (SHUTi, or "Shut-Eye"), can help to improve the sleep of people who are in remission from cancer and experiencing symptoms of insomnia.
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 22 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cancer patient
Insomnia diagnosis (combined from DSM-IV and ICSD):
Difficulty staying asleep (≥30 minutes awake in the middle of the night)
Exclusion Criteria:
Having an "unusual" sleep pattern
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.
Behavioral: Sleep Healthy Using the Internet (SHUTi) · Behavioral: Hypnosis recordings
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.
Behavioral: Sleep Healthy Using the Internet (SHUTi)
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.
Behavioral: Hypnosis recordings
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.
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.
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
Insomnia Severity Index (ISI)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Sleep Efficiency
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Total Sleep Time
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Sleep Onset Latency (SOL)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Wake After Sleep Onset (WASO)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Number of Nighttime Awakenings
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Hospital Depression and Anxiety Scale
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Pain scale
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Multidimensional Fatigue Symptom Inventory
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Quality of Life (SF-12 Health Survey)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Hot flashes
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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