Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT04779866
Brief 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.
Detailed 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:
NCT04779866
Study Brief:
Protocol Section:
NCT04779866