Improvisatory Music for Anxiety in Alzheimer's Disease
Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music
Recruiting
N/AInterventional Study
Alzheimer's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
55 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for people with Alzheimer's disease and anxiety, along with their caregivers. Participants will take part in music sessions designed to help reduce anxiety or listen to calming stories over four weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Alzheimer's disease.
I have positive Alzheimer's disease biomarkers.
I have a Mini-Mental State Exam score of 15 or higher.
I have a RAID score above 8.
You may not be able to join if
I have significant hearing impairments.
I have major comorbidities with a Beck Depression Inventory score above 10.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study examines whether Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in people living with Alzheimer's disease and anxiety (AD-A), and whether it can also lessen caregiver burden. CDIM is a live, receptive music-based intervention that uses slow tempi, simple diatonic melodic lines, soft dynamics, and periodic pauses to promote relaxation. As described in the proposal, CDI…
This study examines whether Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in people living with Alzheimer's disease and anxiety (AD-A), and whether it can also lessen caregiver burden. CDIM is a live, receptive music-based intervention that uses slow tempi, simple diatonic melodic lines, soft dynamics, and periodic pauses to promote relaxation. As described in the proposal, CDIM has previously been shown to reduce stress and improve physiological markers such as heart rate, blood pressure, and EEG alpha/beta ratios (CDIM significantly decreased physical stress symptoms and patients also reported positive emotional outcomes and EEG readings showed increased alpha/beta brainwave ratios ).
The study will enroll 30 dyads (individuals with AD-A and their caregivers). Dyads will be randomly assigned to either CDIM or a control intervention (CI) consisting of calming short stories read aloud. Both interventions include eight 30-minute sessions over four weeks, delivered in alternating in-person and virtual formats.
The primary goal is to determine whether CDIM is feasible and effective in reducing anxiety in individuals with AD-A, measured by the Rating Anxiety in Dementia (RAID) scale, and in reducing caregiver burden, measured by the Zarit Burden Interview (ZBI). The study also evaluates changes in heart rate and blood pressure as indicators of autonomic regulation.
A second goal is to explore whether CDIM improves central auditory processing, assessed using the frequency-following response (FFR). The proposal notes that central auditory processing declines with age and dementia and may contribute to anxiety. FFR will be measured before and after the intervention to determine whether CDIM enhances neural timing and response magnitude.
Overall, this pilot study aims to determine whether CDIM is a feasible, safe, and potentially effective non-pharmacological intervention for reducing anxiety in individuals with AD-A and decreasing caregiver burden, while also investigating its underlying neurophysiological mechanisms.
Trial Locations
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Eligibility Criteria
Inclusion Criteria
* Clinical diagnosis of Alzheimer's Disease
* Positive Alzheimer's disease biomarkers (blood test, amyloid PET scan or CSF)
* Mini-mental State Exam (MMSE) \>=15
* Rating for Anxiety in Dementia (RAID) score \> 8
Exclusion Criteria
* Significant hearing impairments
* Major como…
Inclusion Criteria
* Clinical diagnosis of Alzheimer's Disease
* Positive Alzheimer's disease biomarkers (blood test, amyloid PET scan or CSF)
* Mini-mental State Exam (MMSE) \>=15
* Rating for Anxiety in Dementia (RAID) score \> 8
Exclusion Criteria
* Significant hearing impairments
* Major comorbidities Beck Depression Inventory (BDI) scores above \> 10'
Contacts
Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA
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