NCT04281225

Mindfulness Intervention and Symptom Variability in Hearing

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Harvard University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2020-02-24
• Last updated: 2022-02-17

Locations

1 site across 1 country: United States