Mindfulness Intervention and Symptom Variability in Hearing

NCT04281225 | Withdrawn

• 1 other identifier: IRB19-0222
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Keywords

attention to variability; placebo; hearing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Langer Mindfulness Scale,14-Item scale

  5 minutes

• Perceived Stress Scale (PSS)

  5 minutes

• Hearing Handicap Inventory for Elderly- Screening (HHIE-S)

  5 minutes

• Hearing Handicap Inventory for Adults- Screening (HHIA-S)

  5 minutes

Study Arms (4)

Placebo only condition

PLACEBO COMPARATOR

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

Placebo and ATV condition

EXPERIMENTAL

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.

Behavioral: Attention to Variability (ATV); Other: Placebo

ATV only condition

EXPERIMENTAL

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)

Control condition- no ATV or Placebo effect.

NO INTERVENTION

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.

Interventions

Attention to Variability (ATV) BEHAVIORAL

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.

ATV only condition; Placebo and ATV condition

Placebo OTHER

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.

Placebo and ATV condition; Placebo only condition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (5)

• 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.

  PMID: 19239577 BACKGROUND

• 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.

  PMID: 23594421 BACKGROUND

• 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.

  PMID: 20803741 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29482764 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ellen Langer, Ph.D.

  Harvard U

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Research Assistants are blind to the conditions of the participants. Participants do not know which condition they have been assigned to either. Only the main investigators (Deb Phillips, Neha Dhawan, Kris Nichols, and Francesco Pagnini) will know which participant is assigned to a particular intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: November 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

US (1)