Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease
NCT ID: NCT04779866
Last Updated: 2023-08-01
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
20 participants
INTERVENTIONAL
2021-03-30
2023-06-01
Brief Summary
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Detailed Description
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Aim 1: Determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among caregivers of individuals with ADRD. Feasibility will be determined by (1) drop-out rate, (2) participants' rating of the program, and (3) participants' rating of treatment satisfaction. Adherence will be determined through at-home practice logs. Essential experience on accrual and retention data as well.
Aim 2: Determine feasibility of measures: PSQI, actigraphy recordings, and sleep diaries to assess sleep quality and duration, as well as feasibility of secondary self-report outcome measures of insomnia severity, stress, cognition, and pain among caregivers.
Aim 3: Determine perceptions of hypnosis and potential barriers for the caregiver population and feedback.
Participant Selection and Recruitment Plan
A sample of 20 caregivers, both male and female, of individuals with ADRD, who suffer from poor sleep will be enrolled in the study. A screening checklist will be used for screening participants who are interested.
Potential participants will be identified (1) via advertisements and press releases, (2) via physician referral, and (3) targeted mailings. Participants eligibility will be determined by criteria listed on a screening checklist. The investigators have used these strategies in prior studies and have demonstrated ability to accrue the required number of participants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Self-Administered Hypnosis
Participants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice.
Self-Administered Hypnosis
Participants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice.
White Noise Hypnosis Control
Participants randomized to the white noise hypnosis control will receive the same information and contact with the therapist, but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction.
Self-Administered White Noise Hypnosis
Participants randomized to the white noise hypnosis control will receive the same information and contact with the therapist, but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction.
Interventions
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Self-Administered Hypnosis
Participants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice.
Self-Administered White Noise Hypnosis
Participants randomized to the white noise hypnosis control will receive the same information and contact with the therapist, but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction.
Eligibility Criteria
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Inclusion Criteria
2. Self-reported sleep duration of 6 or less hours per day/night as indicated on the PSQI
3. Signed informed consent
4. Access to a computer or mobile device with reliable Internet connection that will allow for the completion of study visits and study materials online
Exclusion Criteria
2. Severe or unstable medical or psychiatric illness
3. Current use of hypnosis for any condition
4. Inability to speak or understand English
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Baylor University
OTHER
Responsible Party
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Gary R. Elkins
Director of Mind-Body Medicine Research Lab
Locations
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Baylor University
Waco, Texas, United States
Countries
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Other Identifiers
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NCT09384
Identifier Type: -
Identifier Source: org_study_id
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