Clinical trial NCT04779866: Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease
Official title: Feasibility of Self-Administered Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Quality Sleep
Caregiver Stress
Alzheimer's Disease (Incl Subtypes)
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Hypnosis Practice Log
timeFrame: Through study completion, an average of 7 weeks
measure: Program Rating Scale
timeFrame: One week
measure: Treatment Satisfaction Scale
timeFrame: One week
measure: Wrist Actigraphy
timeFrame: up to 2 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: up to 2 weeks
measure: Daily Sleep Diaries
timeFrame: Through study completion, an average of 7 weeks
measure: Epworth Sleepiness Scale
timeFrame: Through study completion, an average of 7 weeks
measure: Sleep Environment Questionnaire
timeFrame: Through study completion, an average of 7 weeks
measure: Attitudes Toward Hypnosis Scale
timeFrame: Through study completion, an average of 7 weeks
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: Through study completion, an average of 7 weeks
measure: Perceived Stress Scale
timeFrame: Through study completion, an average of 7 weeks
measure: PROMIS Cognitive Function - Short Form
timeFrame: Through study completion, an average of 7 weeks
measure: Pain Visual Analog Scale
timeFrame: Through study completion, an average of 7 weeks
measure: Motivation Scale
timeFrame: One week during baseline week
Other outcomes:
measure: Post-Participation Interview
timeFrame: 1 week
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
References: