The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment

Anxiety Clinical Trial

Official title:

The Effects of Music Listening on Anxiety and Agitation in People With Mild and Moderate Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858541
• Other study ID #: APP-23-02029
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: Assal Habibi
• Phone: 2137403588
• Email: ahabibi[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Advancing age is associated with an increased risk of developing dementia which can lead to a rapid acceleration in both the healthcare costs and caregiver burden. There is a need to develop non-pharmacological and easily accessible modalities of support for the well-being and enhancing quality of life for individuals with dementia. There is evidence that music listening is associated with stress and anxiety reduction in older adults. Here, the investigators aim to assess the effects of music listening as provided by a novel digital music-based intervention (developed by LUCID) on mood, anxiety, and quality of life in individuals at the early stages of dementia. LUCID uses reinforcement learning machine learning to curate and personalize the musical playlist while incorporating monoaural theta auditory beat stimulation (ABS) into the music. The study will be conducted remotely with study hardware (tablets and Bluetooth speakers) being delivered to caregivers/participants. The study will take place over an 8- week period, with participants completing four 30 mins music or audiobook listening sessions per week. Pre and post-intervention assessments will be done via Zoom with the presence of a research staff member. The control condition consists of a randomized list of short audiobooks. The experimental condition consists of music and monoaural ABS curated by LUCID's AI system. The investigators hypothesize that the LUCID AI music curation system, compared to audiobooks, will be correlated with a greater reduction in measures of anxiety and agitation and an enhancement of mood and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Mild to Moderate Cognitive Impairment (mild: MOCA scores (18-25); moderate: MOCA scores (10-17))
• Aged 65-85.

Exclusion Criteria:

• Unmanaged hearing loss (defined as the average pure-tone average threshold of 35 dB HL or greater without the use of hearing instruments or personal sound amplification product) - self-report
• Severe Tinnitus
• Hyperacusis
• Current (but not prior) severe psychiatric disorder, an unstable or serious medical condition that may limit participation in the assessments.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cognitive Dysfunction

Intervention

Behavioral:
• Music Listening
The LUCID AI-based system for song selection responds to the collected measurement data (video and HRV) and music preference information (like/dislike button, music taste profile) to recommend the playlist for the listener. The songs are selected using 76 different musical features and raw audio information. The system uses these features to recommend and optimize recommendations for the listener
• Listening to Audiobooks
A selection of 40 audiobooks spanning 4 genres (10 each from Literary Classics, Fantasy, Mystery, Non-fiction) will be available. For each session, the participant and their caregiver will be given a prompt to make a genre selection. After making the genre selection, one of the ten stories associated with that genre will be selected at random. All stories were sampled from the Audible audiobook database. Stories had to be 30 minutes in length to align with the length of the music interventions and the selected stories had to have had a 4- or 5-star rating to ensure quality.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	Change in depression as measured by Geriatric Depression Scale 0 is minimum and 15 is maximum with 15 being highest rate of depression	8 weeks
Other	Well-being	Change in quality of life as measured by Cornell Brown Scale for Quality of Life in Dementia - Minimum score: -38. Maximum score: 38. Higher score indicates better outcome (increased quality of life)	8 weeks
Other	Caregiver Burden	Change in caregiver burden measured by Zarit caregiver burden	8 weeks
Other	Anxiety and Mood	Change in Mood and Anxiety as measured by PANAS Positive and Negative Affect Schedule	pre and post 20 mins session for a total of 32 sessions
Other	Arousal	Change in affect as measured by high low arousal	pre and post 20 mins session for a total of 32 sessions
Other	Valence	Change in affect as measured by positive negative valence	pre and post 20 mins session for a total of 32 sessions
Other	Memory	Changes in memory recall measured by vividness and specificity of recalled memories	8 weeks
Primary	Agitation Trait	Change in agitation as measured by the Cohen-Mansfield Agitation Index	8 weeks
Primary	Agitation State	Change in agitation as measured by Overt Agitation Scale (OAS)	pre and post 20 mins session for a total of 32 sessions
Primary	Agitation State	Change in agitation as measured by Positive and Negative Syndrome Scale, Excited Component (PANSS-EC)	pre and post 20 mins session for a total of 32 sessions
Secondary	Anxiety	Change in Anxiety in Dementia Scale (RAID)-Minimum value: 0, Maximum value: 54. Higher score	8 weeks
Secondary	Anxiety	Change in State-trait cognitive and somatic anxiety (STICSA)	8 weeks