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

Baylor University

Status: Completed

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

Treatments: Behavioral: Self-Administered White Noise Hypnosis; Behavioral: Self-Administered Hypnosis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04779866

3R01AT009384-04S1 (U.S. NIH Grant/Contract)

NCT09384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Active caregiver to an individual with Alzheimer's disease or its related dementias
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

1. Use of any prescription or over-the-counter therapy for sleep
2. Severe or unstable medical or psychiatric illness
3. Current use of hypnosis for any condition
4. Inability to speak or understand English

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Self-Administered Hypnosis

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Administered Hypnosis

White Noise Hypnosis Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Administered White Noise Hypnosis