Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's

Status Completed

Clinical Trial Summary

The long-range goal is to identify an efficacious and practical intervention to improve sleep quality and duration for family caregivers of individuals with Alzheimer's disease and related dementias (ADRD). The main goal of this study is to determine feasibility of a self-administered hypnosis intervention with caregivers of individuals with ADRD by randomizing eligible participants into one of two study arms, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group). The investigators are also examining the feasibility of accrual, outcome measures (diaries, actigraphy) and study design.

Clinical Trial Description

Study Objectives 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. ;

Study Design

Related Conditions & MeSH terms

Alzheimer Disease
Alzheimer's Disease (Incl Subtypes)
Caregiver Stress
Poor Quality Sleep

Clinical Trial Details

NCT number	NCT04779866
Study type	Interventional
Source	Baylor University
Contact
Status	Completed
Phase	N/A
Start date	March 30, 2021
Completion date	June 1, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms