Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment

Baylor University

Status: Completed

Conditions: Mild Cognitive Impairment; Poor Quality Sleep

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05215717

3R01AT009384-05S1

Details and patient eligibility

About

With the long-range goal to identify an efficacious and practical intervention to improve sleep for individuals with MCI, this pilot study will enroll 20 individuals with MCI into either a self-administered hypnosis for sleep program or a sham white noise hypnosis program. Participants will practice hypnosis delivered via audio recording once per day in their own home for 7 weeks. Upon completion of the study, insight will be gained regarding accrual, retention, and feasibility of the intervention and measures. Data from this pilot study is essential to inform and plan a future R01 proposal to determine the efficacy of the self-administered hypnosis intervention to improve sleep quality and duration, as well as other benefits, with individuals with mild cognitive impairment.

Full description

Study Objectives

Aim 1: Determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among individuals with MCI. 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 individuals with MCI.

Aim 3: Determine perceptions of hypnosis and potential barriers for the MCI population and feedback.

Participant Selection and Recruitment Plan

A sample of approximately 20 individuals with mild cognitive impairment, both male and female, 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 and health care provider referral, support groups (3) and (4) targeted mailings. Participant's eligibility will be determined by criteria listed on a screening checklist. The investigator has used these strategies in prior studies and has demonstrated ability to accrue the required number of participants.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Self-report of MCI (a score of less than or equal to 3 on the Memory Complaint Scale30) and a score between 7-18 on the Montreal Cognitive Assessment (MoCA) - BLIND Version 8.121
• Self-reported sleep duration of less than or equal to 6 hours per day/night as indicated on the PSQI
• Signed informed consent

Exclusion criteria

• Use of any prescription or over-the-counter therapy for sleep
• Severe or unstable medical or psychiatric illness
• Current use of hypnosis for any condition
• 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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23 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