Mindfulness Intervention and Symptom Variability in Hearing

The purpose of this study is to investigate the efficacy of mindfulness and placebo treatments on hearing improvement. More specifically, the researchers will be investigating whether the following variables impact the effectiveness of placebo treatment such as: mindfulness, and attention to variability. Extant research has found the effectiveness of psychological treatment in multiple domains, and the researchers look to further investigate this success in the domain of hearing symptom sensations.

Study Overview

• Status: Withdrawn
• Conditions: Hearing Loss
• Intervention / Treatment: Other: Placebo; Behavioral: Attention to Variability (ATV)

Detailed Description

The placebo effect, described as "psychological or physiological responses attributed to expectations of an inert substance or procedure, has been demonstrated to have powerful effects in multiple instances (Colloca & Benedetti, 2005). Although research on the placebo effect is prolific, the mechanisms involved can vary based on the context and have been difficult to research with consistent approaches and results (Brown et al., 2013; Holmes et al., 2018). Some researchers have found that the mere perception of a treatment as "new" is enough to elicit a placebo effect, while others have found that the key mechanism may be attention to symptoms - nevertheless, "little evidence exists on the precise mechanisms through which psychological treatments actually work" (Brown et al., 2013; Holmes et al., 2018).

Earlier work suggests the potential for psychological treatments for hearing loss or other forms of hearing disability, including coping techniques (Scott et al, 2009). This study aims to extend the mind-body unity theory as suggested by Dawes et al. (2013) who found in two successive studies that there is a reliable placebo effect in hearing-aid trials. While the objective of these studies was to encourage double-blind methodology (to optimize results), these results suggest that such effects can optimize outcomes and as the audiology field does not typically consider placebo effects. it suggests that hearing improvements can be impacted by (positive) expectations in a "general" sense (not a specific type of hearing aid but simply a "new technology" hearing aid). While this will be of great use clinically in double blind trials, it suggests that the use of a psychological construct, specifically the Langerian attention to variability construct, can function to encourage a placebo effect or a clinical response by encouraging a sense of personal control over the symptoms of the hearing loss. In this study, researchers will look to further investigate one potential mechanism important to the placebo effect - attention to variability.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Harvard University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between 18 and 80 years of age
• Eyesight with corrective lenses sufficient enough to read and respond to emails
• Owns or has access to and is familiar with using a smartphone and/or desk top/laptop with a cellular data plan and email host
• Able to receive and respond to text messages and emails
• Able to and access to watch, listen to and operate on a phone or computer a video or recording
• English speaking and reading at 8th grade level
• Self-Perceived mild to moderate hearing problem with onset after age 18 (adult onset)

Exclusion Criteria:

• Under age 18 or over age 80
• Unable to read and respond to texts or emails
• No Smartphone or desktop/laptop access
• Hearing loss onset prior to age 18
• Co-morbid conditions such as cancer, diabetes, cardiovascular disease diagnosed and under treatment in the past 6 months
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo only condition; Participants in this condition will be told at the time of the initial assessments (T1) that the device they will be testing will improve their hearing. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will be asked if they perceive their hearing to be changed by the device in addition to qualitative descriptions of the audio. This group will allow researchers to investigate the main effect of the placebo hearing aid - without calling participant's attention to variability in their symptoms.	Other: Placebo; Participants are told that the device they will be testing will improve their hearing, when in fact the device is not a hearing aid but just a metallic earring.
EXPERIMENTAL: Placebo and ATV condition; Participants in this condition at the time of the initial assessments (T1) will be told that the device they will be testing will improve their hearing. They will then be told that in-order to receive the maximum benefit from the hearing device, they should focus on instances in which they can hear better and worse. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will asked 1) if they perceive their hearing to be changed by the device; 2) to note any changes in what they heard in the audio focusing on the story in the ballad; and 3) whether their hearing is possibly impacted by activities and behavior and what they were doing.This condition will enable researchers to test the effects of the interaction between attention to variability and the placebo effect.	Other: Placebo; Participants are told that the device they will be testing will improve their hearing, when in fact the device is not a hearing aid but just a metallic earring.; Behavioral: Attention to Variability (ATV); In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and behavior that occur throughout the day, and to notice changes they experience with their hearing loss symptoms; noticing if it is better or worse and to ask why it may be.
EXPERIMENTAL: ATV only condition; Participants in this condition will be told that the device they will be testing is merely a prototype that they are testing for design purposes. However, these participants will also be told that their input while wearing the device will help the team in developing the final device and allow the team to focus on how to best improve hearing. All participants will be instructed to put on the hearing device and listen to an audio twice per day for 6 days. After listening to the 2nd audio of the day, they will be asked 1) to note any changes in what they heard in the audio focusing on the story in the ballad and 2) whether their hearing might possibly be impacted by activities and behavior. They will also be asked 3) about their general health and wellness, as compared to the last time they were contacted by email. This condition will enable researchers to test the main effect of attention to variability, without an explicit placebo effect.	Behavioral: Attention to Variability (ATV); In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and behavior that occur throughout the day, and to notice changes they experience with their hearing loss symptoms; noticing if it is better or worse and to ask why it may be.
NO_INTERVENTION: Control condition- no ATV or Placebo effect.; Participants in this condition will be told that the device they will be testing is merely a prototype that they are testing for ergonomic purposes. They will listen to the audio and record volume levels at the start and at the end of the audio and provide feedback on the design. They will be told that each day they will listen to a brief audio (ballad of under 3 minutes) and will be asked a few similar questions twice daily for 6 days. After the 2nd audio of the day, they will be asked for feedback on the hearing device design. They will also be asked about their general health and wellness, as compared to the last time they were contacted.This group will allow researchers to test for the effects of having any device at all.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing Change - subjective preferred volume	Participants will be told to wear the hearing device and listen to a brief audio (ballad of under 3 minutes) twice a day daily for 6 days.The survey will ask them to listen to the audio and record the volume level that they used at the beginning and at the end, and then answer a few questions after. The change in participants subjective preferred volume over the course of the week , compared to T1 at the beginning of the week, will represent hearing change.	5 minutes daily for 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Langer Mindfulness Scale,14-Item scale	3 subscales, each ranging from 1-7, with 1 being 'Strongly Disagree' and 7 being 'Strongly Agree'. Subscales are 'Flexibility'; 'Novelty Seeking'; and 'Novelty Producing'.Ratings on these items are then added together to create a score for each subscale and an overall mindfulness score. Higher scores indicate greater mindfulness, and can range from 14 to 98.	5 minutes
Perceived Stress Scale (PSS)	This 10 item scale asks questions about one's feelings and thoughts during the past month. In each question, individuals are asked how often they felt or thought a certain way on a scale from 0 (Never) to 4 (Very Often). Scores can range from 0 to 40, with a greater values is indicating greater perceived stress. Scoring: Each item is rated on a 5-point scale ranging from (0) never to (4) almost always	5 minutes
Hearing Handicap Inventory for Elderly- Screening (HHIE-S)	For participants over the age of 65. The Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) is a 10-item questionnaire that assesses how an individual perceives the social and emotional effects of hearing loss. The higher the HHIE-S score, the greater the handicapping effect of a hearing impairment. Possible scores range from 0 (no handicap) to 40 (maximum handicap).	5 minutes
Hearing Handicap Inventory for Adults- Screening (HHIA-S)	Similar to the HHIE-S above but for adult participants under the age of 65. The higher the HHIA- S score, the greater the handicapping effect of a hearing impairment. Possible scores range from 0 (no handicap) to 40 (maximum handicap).	5 minutes

Collaborators and Investigators

• Sponsor: Harvard University
• Investigators: Principal Investigator: Ellen Langer, Ph.D., Harvard U

Publications and helpful links

General Publications

• Bertisch SM, Legedza AR, Phillips RS, Davis RB, Stason WB, Goldman RH, Kaptchuk TJ. The impact of psychological factors on placebo responses in a randomized controlled trial comparing sham device to dummy pill. J Eval Clin Pract. 2009 Feb;15(1):14-9. doi: 10.1111/j.1365-2753.2008.00942.x.
• Dawes P, Hopkins R, Munro KJ. Placebo effects in hearing-aid trials are reliable. Int J Audiol. 2013 Jul;52(7):472-7. doi: 10.3109/14992027.2013.783718. Epub 2013 Apr 18.
• Labus J, Breil J, Stutzer H, Michel O. Meta-analysis for the effect of medical therapy vs. placebo on recovery of idiopathic sudden hearing loss. Laryngoscope. 2010 Sep;120(9):1863-71. doi: 10.1002/lary.21011.
• Brown, J. A., Fowler, S. L., Rasinski, H. M., Rose, J. P., & Geers, A. L. (2013). Choice as a moderator of placebo expectation effects: Additional support from two experiments. Basic and Applied Social Psychology, 35(5), 436-444.
• Holmes EA, Ghaderi A, Harmer CJ, Ramchandani PG, Cuijpers P, Morrison AP, Roiser JP, Bockting CLH, O'Connor RC, Shafran R, Moulds ML, Craske MG. The Lancet Psychiatry Commission on psychological treatments research in tomorrow's science. Lancet Psychiatry. 2018 Mar;5(3):237-286. doi: 10.1016/S2215-0366(17)30513-8. No abstract available.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: placebo; hearing; attention to variability
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: IRB19-0222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No