Mindfulness Intervention and Symptom Variability in Hearing

Hearing Loss Clinical Trial

Official title:

Mindfulness Intervention and Symptom Variability in Hearing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04281225
• Other study ID #: IRB19-0222
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2022
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Harvard University	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.

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. — View Citation

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. Review. — View Citation

Labus J, Breil J, Stützer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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