NCT00716872

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jul 2008

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

First Submitted

Initial submission to the registry

June 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

Enrollment Period

1.3 years

First QC Date

June 18, 2008

Last Update Submit

February 24, 2010

Conditions

CancerInsomnia

Keywords

cancersleepinsomniaInternetSHUTi

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (8)

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (4)

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.

Behavioral: Sleep Healthy Using the Internet (SHUTi)Behavioral: Hypnosis recordings

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.

Behavioral: Sleep Healthy Using the Internet (SHUTi)

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.

Behavioral: Hypnosis recordings

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.

Interventions

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.

ImmedSHUTi/DelayHypImmedSHUTi/ImmedHyp
Hypnosis recordingsBEHAVIORAL

Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.

DelaySHUTi/ImmedHypImmedSHUTi/ImmedHyp

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 treatment

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Department of Psychiatry & Neurobehavioral Sciences

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • 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.

    PMID: 16135475BACKGROUND

MeSH Terms

Conditions

NeoplasmsSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2008

First Posted

July 16, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations

US(1)