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

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ClinicalTrials.gov Identifier: NCT04779866
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gary R. Elkins, Baylor University

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.

Condition or disease Intervention/treatment Phase
Poor Quality Sleep Caregiver Stress Alzheimer's Disease (Incl Subtypes) Behavioral: Self-Administered Hypnosis Behavioral: Self-Administered White Noise Hypnosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Double
Primary Purpose: Supportive Care
Official Title: Feasibility of Self-Administered Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021


Arm Intervention/treatment
Experimental: Self-Administered Hypnosis
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
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.

Active Comparator: White Noise Hypnosis Control
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
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.




Primary Outcome Measures :
  1. Self-Hypnosis Practice Log [ Time Frame: Through study completion, an average of 7 weeks ]
    Participants will be instructed in daily practice of hypnosis and asked to keep a daily self-hypnosis practice form during the intervention period.

  2. Program Rating Scale [ Time Frame: One week ]
    In order to assess participants' perceptions of the value of the hypnosis program they receive, they will be asked "How do participants rate this hypnosis program overall in regard to ease of use?" and "How do participants rate this hypnosis program overall in regard to improving sleep?" Responses will be given on a 10-point scale ranging from 1 (Poor) to 10 (Excellent) at follow-up.

  3. Treatment Satisfaction Scale [ Time Frame: One week ]
    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.

  4. Wrist Actigraphy [ Time Frame: up to 2 weeks ]
    Wrist actigraphy is a widely used and well-validated measure of sleep duration. Participants will be asked to wear an actigraph (Actiwatch Spectrum Pro), resembling a wrist watch, 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 Actiware 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. For the present study, participants will be asked to wear the actigraph for one week at baseline and for one week at follow-up.

  5. Pittsburgh Sleep Quality Index [ Time Frame: up to 2 weeks ]
    Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) during screening and at follow-up to measure sleep quality. 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 .8024.

  6. Daily Sleep Diaries [ Time Frame: Through study completion, an average of 7 weeks ]
    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.

  7. Epworth Sleepiness Scale [ Time Frame: Through study completion, an average of 7 weeks ]
    Participants will be asked to complete the Epworth Sleepiness Scale (ESS) to assess daytime sleepiness. 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 .8827.

  8. Sleep Environment Questionnaire [ Time Frame: Through study completion, an average of 7 weeks ]
    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."

  9. Attitudes Toward Hypnosis Scale [ Time Frame: Through study completion, an average of 7 weeks ]
    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 = .8128. 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.


Secondary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: Through study completion, an average of 7 weeks ]
    Participants will be asked to complete the Insomnia Severity Index (ISS) to measure insomnia symptom severity. The ISS consists of seven items that measure the severity of sleep onset, sleep maintenance, and early morning awakening problems, as well as the participant's satisfaction with her current sleep pattern, the extent to which lack of sleep interferes with daily functioning, how noticeable this impairment is to other people, and the extent to which the participant is worried or distressed about their lack of sleep. Items are scored on a scale from 0-4 with total score of 15 or higher indicating the presence of clinical insomnia25. Past research indicates that internal reliability estimates for the ISI range from .74 to .7825.

  2. Perceived Stress Scale [ Time Frame: Through study completion, an average of 7 weeks ]
    The Perceived Stress Scale (PSS) will be used to measure stress at baseline and follow-up. The PSS includes 14 items that assess levels of perceived stress and to what degree individuals perceive events in their life as stressful during the previous month. Higher scores indicate greater stress. Past research indicates that Cronbach's alpha for the PSS is .8526.

  3. PROMIS Cognitive Function - Short Form [ Time Frame: Through study completion, an average of 7 weeks ]
    Cognition will be assessed using the PROMIS Cognitive Function - Short Form Scale. This scale includes 8 items and measures self-reported cognitive functioning during the past 7 days. Items are scored from a scale of 1 (Very Often) to 5 (Never). Items are summed to create a total score and higher scores indicate better cognitive functioning.

  4. Pain Visual Analog Scale [ Time Frame: Through study completion, an average of 7 weeks ]
    Participants will be asked to rate their pain on a 100-mm visual analog scale (VAS) during baseline and follow-up. Participants will be asked to place an "x" along the 100-mm line to indicate the severity of their pain over the past week, with the lower end of the scale being anchored by the phrase "no pain" and the upper end of the scale being anchored by the phrase "the most intense pain possible."

  5. Motivation Scale [ Time Frame: One week during baseline week ]
    Motivation to use hypnosis is an important factor to be assessed. Motivation to use hypnosis to improve sleep quality will be assessed at baseline using a numerical rating scale that states, "How motivated are participants to use hypnosis to improve sleep?" This item will be rated on a scale of 1 (Not Motivated at All) to 10 (Very Motivated).


Other Outcome Measures:
  1. Post-Participation Interview [ Time Frame: 1 week ]
    In order to gather qualitative data to improve future studies, participants will be asked to participate in a post-participation interview. An experienced and trained doctoral student will conduct interviews and create summary statements regarding topics including ease of use of the intervention, barriers of using the audio recordings, finding the time to practice, and improvement of the intervention. Interviews will be recorded and transcripts will be typed out.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779866


Contacts
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Contact: Whitney Williams, M.S. 254-296-0824 Whitney_Williams@baylor.edu
Contact: Gary Elkins, Ph.D. 254-296-0643 Gary_Elkins@baylor.edu

Locations
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United States, Texas
Baylor University Recruiting
Waco, Texas, United States, 76798
Contact: Whitney Williams, M.S.    254-296-0824    whitney_williams@baylor.edu   
Contact: Gary Elkins, Ph.D.    254-296-0643    gary_elkins@baylor.edu   
Principal Investigator: Gary Elkins, Ph.D.         
Sponsors and Collaborators
Baylor University
National Center for Complementary and Integrative Health (NCCIH)
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Responsible Party: Gary R. Elkins, Director of Mind-Body Medicine Research Lab, Baylor University
ClinicalTrials.gov Identifier: NCT04779866    
Other Study ID Numbers: NCT09384
3R01AT009384-04S1 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders