Clinical trial NCT05215717: Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment
Official title: Feasibility of Self-Administered Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Poor Quality Sleep
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-01-31
Enrollment: 23
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 enrolled into one of two study groups, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily At-home 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 - Objective Sleep Duration
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: