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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ImmedSHUTi/ImmedHyp | Experimental | 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. |
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| ImmedSHUTi/DelayHyp | Experimental | 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. |
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| DelaySHUTi/ImmedHyp | Experimental | 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. |
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| DelaySHUTi/DelayHyp | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Healthy Using the Internet (SHUTi) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | prior to intervention, after SHUTi use, after Hypnosis use | |
| Sleep Diary: Sleep Efficiency | prior to intervention, after SHUTi use, after Hypnosis use | |
| Sleep Diary: Total Sleep Time | prior to intervention, after SHUTi use, after Hypnosis use |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Diary: Sleep Onset Latency (SOL) | prior to intervention, after SHUTi use, after Hypnosis use | |
| Sleep Diary: Wake After Sleep Onset (WASO) | prior to intervention, after SHUTi use, after Hypnosis use |
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Inclusion Criteria:
Age = At least 21 years old
Regular access to the Internet, including e-mail
Cancer patient
Insomnia diagnosis (combined from DSM-IV and ICSD):
Difficulty falling asleep (≥30 minutes to fall asleep) OR
Difficulty staying asleep (≥30 minutes awake in the middle of the night)
Participant feels that the insomnia was caused/aggravated by cancer or cancer treatment
Exclusion Criteria:
Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy, parasomnias)
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Lee M Ritterband, Ph.D. | University of Virginia | Principal Investigator |
| Lora D Baum, Ph.D. | University of Virginia | Principal Investigator |
| Elaine T Bailey, Ph.D. | University of Virginia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Department of Psychiatry & Neurobehavioral Sciences | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16135475 | Background | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Hypnosis recordings | Behavioral | Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep. |
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| Sleep Diary: Number of Nighttime Awakenings | prior to intervention, after SHUTi use, after Hypnosis use |
| Hospital Depression and Anxiety Scale | prior to intervention, after SHUTi use, after Hypnosis use |
| Pain scale | prior to intervention, after SHUTi use, after Hypnosis use |
| Multidimensional Fatigue Symptom Inventory | prior to intervention, after SHUTi use, after Hypnosis use |
| Quality of Life (SF-12 Health Survey) | prior to intervention, after SHUTi use, after Hypnosis use |
| Hot flashes | prior to intervention, after SHUTi use, after Hypnosis use |
| D001523 |
| Mental Disorders |