Clinical trial NCT04281225: Mindfulness Intervention and Symptom Variability in Hearing
Official title: Mindfulness Intervention and Symptom Variability in Hearing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Keywords: attention to variability
placebo
hearing
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hearing Change - subjective preferred volume
timeFrame: 5 minutes daily for 6 days
Secondary outcomes:
measure: Langer Mindfulness Scale,14-Item scale
timeFrame: 5 minutes
measure: Perceived Stress Scale (PSS)
timeFrame: 5 minutes
measure: Hearing Handicap Inventory for Elderly- Screening (HHIE-S)
timeFrame: 5 minutes
measure: Hearing Handicap Inventory for Adults- Screening (HHIA-S)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard U
name: Ellen Langer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.
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. No abstract available.