Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment

NCT05215717 | Completed

• 1 other identifier: 3R01AT009384-05S1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Poor Quality Sleep

Outcome Measures

Primary Outcomes (9)

• Daily At-home Self-Hypnosis Practice Log

  All participants will be given guidance on the use of hypnosis and recordings for at-home practice throughout the study. Participants will be instructed in daily practice of hypnosis and asked to keep a daily at-home self-hypnosis practice form during the intervention period. Adherence will be assessed via calculation of participants' frequency of hypnosis practice from these daily hypnosis practice forms. The participant will be asked to practice daily and to complete a practice log, recording the frequency of practice of self-administered hypnosis. Practice logs will be used to assess frequency of practice.

  Through study completion, an average of 7 weeks

• Program Rating Scale

  In order to assess participants' perceptions of the value of the hypnosis program they receive, they will be asked "How do you rate this hypnosis program overall in regard to ease of use?" and "How do you rate this hypnosis program overall in regard to improving your sleep?" Responses will be given on a 10-point scale ranging from 1 (Poor) to 10 (Excellent) at follow-up.

  One week

• Treatment Satisfaction Scale

  Participants will be asked to rate their overall level of satisfaction with the intervention. A 10-point VAS scale anchored with 0 "Completely Dissatisfied" to 10 "Completely Satisfied" will be given at follow-up.

  One week

• Wrist Actigraphy - Objective Sleep Duration

  Wrist actigraphy is a widely used and well-validated measure of sleep duration. Participants will be asked to wear an actigraph (Actiwatch 2; Phillips Respironics, Andover, MA), resembling a wristwatch, on their non-dominant wrist. A motion detection device located within the actigraph records movement. After data is collected and stored within the actigraph it can be analyzed with the Philips Respironics 5 software program. This program uses a series of logarithms to measure various factors associated with sleep quality, such as total sleep duration, sleep efficiency, sleep onset latency, and the number of times participants woke during the night. Each of these factors will be combined to assess and report objective sleep duration in hours per day/night for participants. For the present study, participants will be asked to wear the actigraph for one week at baseline and for one week at follow-up.

  Up to 2 weeks

• Pittsburgh Sleep Quality Index

  Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) during screening and at follow-up. The PSQI is a 19-item self-report inventory designed to measure sleep quality. The 19 items are grouped into 7 subscales: 1) sleep quality, 2) sleep efficiency, 3) daytime dysfunction, 4) sleep latency, 5) sleep disturbances, 6) sleep duration, and 7) use of sleep medication. These seven subscales are scored on a scale of 0-3 with higher scores indicating greater sleep pathology. Cronbach's alphas for the PSQI range from .70 to .80.

  Up to 2 weeks

• Daily Sleep Diaries

  A daily sleep diary where participants record time awake and time to bed will be used. Participants will be asked to complete a daily sleep diary upon awakening each morning for a week at baseline, daily during the intervention weeks, and a week at follow-up.

  Through study completion, an average of 7 weeks

• Epworth Sleepiness Scale

  Participants will be asked to complete the Epworth Sleepiness Scale (ESS) during baseline and at follow-up. The ESS is an 8-item self-report measure that asks participants to indicate how likely they are to fall asleep while engaging in eight different everyday activities (e.g., watching television, sitting in traffic). Items are scored on a scale from 0-3 with higher scores indicating a greater probability of falling asleep. Previous research indicates that the ESS has a Cronbach's alpha of .88

  Through study completion, an average of 7 weeks

• Sleep Environment Questionnaire

  Participants will be asked to complete the Sleep Environment Questionnaire during baseline and at follow-up. The Sleep Environment Questionnaire is an 11- item self-report measure that asks about the environment in which a person sleeps. Response options include "True," "False," or "Not Applicable."

  Through study completion, an average of 7 weeks

• Attitudes Toward Hypnosis Scale

  The 14-item Attitudes Toward Hypnosis Scale will be used to assess attitudes toward hypnosis at baseline and at follow-up. This scale has shown internal consistency in previous studies, Cronbach's alpha = .81. A total attitude toward hypnosis score will be calculated for each participant by summing scores across the 14 items with higher scores indicating more positive attitudes toward hypnosis.

  Through study completion, an average of 7 weeks

Secondary Outcomes (5)

• Insomnia Severity Index

  Through study completion, an average of 7 weeks

• Perceived Stress Scale

  Through study completion, an average of 7 weeks

• PROMIS Cognitive Function - Short Form

  Through study completion, an average of 7 weeks

• Pain Visual Analog Scale

  Through study completion, an average of 7 weeks

• Motivation Scale

  One week during baseline week

Other Outcomes (1)

• Post-Participation Interview

  1 week

Study Arms (2)

Self-Administered Hypnosis

EXPERIMENTAL

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.

Behavioral: Self-Administered Hypnosis

White Noise Hypnosis Control

ACTIVE COMPARATOR

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.

Behavioral: Self-Administered White Noise Hypnosis

Interventions

Self-Administered Hypnosis BEHAVIORAL

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.

Self-Administered Hypnosis

Self-Administered White Noise Hypnosis BEHAVIORAL

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.

White Noise Hypnosis Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Mind-Body Medicine Research Lab

Model Details: Participants will be randomized and enrolled into one of two study groups, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group).

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 31, 2022
• Study Start: February 22, 2022
• Primary Completion: November 6, 2022
• Study Completion: November 6, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

US (1)