Impact of Harp Therapy on Behavioral Disorders in Nursing Home Residents With Neurodegenerative Disease (ARPE)

NCT07748013 | Completed

• 1 other identifier: ARPE
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The ARPE study looked at whether weekly harp therapy sessions could reduce behavioral problems in older adults living in memory care units of a nursing home (EHPAD). These residents had moderate-to-severe neurodegenerative diseases (such as Alzheimer's disease or related conditions) and displayed disruptive behaviors, especially in the late afternoon and evening. Harp therapy (harpe-thérapie) is a form of receptive music therapy. During each session, a trained harp therapist plays music live for participants. Unlike other music therapy approaches, residents simply listen - they do not need to move, sing, or play an instrument. Receptive music therapy uses sound to promote relaxation, reduce anxiety, and stimulate memory and emotions. The main questions this study aimed to answer were: Can weekly harp therapy sessions reduce neuropsychiatric symptoms (such as agitation, anxiety, and sleep disturbances) in residents with neurodegenerative diseases? Does harp therapy reduce the use of psychotropic medications (sleeping pills, antidepressants, antipsychotics)? Does harp therapy improve residents' well-being immediately before and after each session? Does harp therapy improve the well-being of care staff and help them manage residents' behavioral difficulties? What participants did: Took part in one collective harp therapy session per week in the late afternoon for 12 weeks Were evaluated for behavioral symptoms at the start of the study, at week 6, at week 12, and 3 months after the last session Were assessed for immediate well-being before and after each session Care staff were asked to rate their own well-being twice a week (once after a harp therapy session, once on a day without a session) The study took place at Villa Éléonore, a single nursing home run by LNA Santé in France, and included all eligible residents from two memory care units.

Conditions

Neurodegenerative Diseases; Behavioral Symptoms; Dementia; Agitation

Keywords

Harp therapy; Music therapy; Neurodegenerative diseases; Neuropsychiatric symptoms; Behavioral and psychological symptoms of dementia; Agitation; Anxiety; Non-pharmacological intervention; Nursing home

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Caregiver Version (NPI-ES) at Week 6, Week 12, and Month 15

  The NPI-ES (Neuropsychiatric Inventory - Échelle pour les Soignants) is a validated, structured caregiver-administered interview assessing 12 neuropsychiatric domains: delusions, hallucinations, agitation/aggression, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, sleep disorders, and appetite changes. Each domain is rated by frequency (1-4) and severity (1-3); domain score = frequency × severity. Total score ranges from 0 to 144; higher score = greater neuropsychiatric symptom burden. Minimum clinically important difference (MCID): not formally established for this population in a single-arm design.

  Baseline (Day 0), Week 6 (after the 6th session), Week 12 (after the 12th session), and Month 15 (3 months after the last session)

Secondary Outcomes (8)

• Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Week 6

  Baseline (Day 0) and Week 6 (after the 6th harp therapy session)

• Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Week 12

  Baseline (Day 0) and Week 12 (after the 12th harp therapy session)

• Change from Baseline in Agitation and Aggression as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI) at Month 15

  Baseline (Day 0) and Month 15 (3 months after the last harp therapy session)

• Change from Baseline in Psychotropic Medication Use at Week 6

  Baseline (6 weeks preceding Day 0) and Week 6 (6 weeks preceding the Week 6 visit)

• Change from Baseline in Psychotropic Medication Use at Week 12

  Baseline (6 weeks preceding Day 0) and Week 12 (6 weeks preceding the Week 12 visit)

Study Arms (1)

Harp Therapy Cohort

Nursing home residents living in one of the two memory care units (unités protégées) of Villa Éléonore (LNA Santé, France), diagnosed with moderate-to-severe neurodegenerative disease (e.g., Alzheimer's disease or related conditions) and presenting moderate-to-severe disruptive behavioral disorders (agitation, anxiety, sleep disturbances), who received one weekly group live harp therapy session in the late afternoon for 12 consecutive weeks. All eligible residents from both units were offered participation (non-probability, consecutive sampling). Behavioral symptoms, psychotropic medication use, and well-being were assessed at baseline, week 6, week 12, and 3 months after the last session.

Behavioral: Harp therapy (receptive music therapy)

Interventions

Harp therapy (receptive music therapy) BEHAVIORAL

arp therapy is a form of receptive music therapy in which a certified harp therapist plays the harp live during group sessions. Participants passively listen to live harp music without any required physical, vocal, or instrumental participation. The acoustic and vibrational properties of the harp are used to promote relaxation, reduce anxiety, and stimulate emotional and memory processes in people with neurodegenerative diseases. In this study, one group session was delivered weekly in the late afternoon (sundowning period) in the memory care unit, for 12 consecutive weeks. Each session lasted approximately 30 to 45 minutes. All eligible residents from both memory care units attended collectively. Harp therapy was provided as part of the facility's non-pharmacological care program and observed prospectively; participants were not assigned to this intervention by the research team.

Harp Therapy Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible residents from the two memory care units of Villa Éléonore, a nursing home operated by LNA Santé in France.

You may qualify if:

• Living permanently in a memory care unit (unité protégée) of Villa Éléonore nursing home for at least 2 months
• Diagnosed with a moderate-to-severe neurodegenerative disease (such as Alzheimer's disease or a related condition), AND/OR Mini-Mental State Examination (MMSE) score of 15 or below (or MMSE not evaluable), assessed within the last 12 months
• Presenting moderate-to-severe disruptive behavioral difficulties, such as anxiety, agitation, nighttime wandering, or difficulty falling asleep
• Participant and/or their legal representative has been informed about the study and has not objected to the use of their pseudonymized data

You may not qualify if:

• Unstabilized psychiatric condition
• Uncorrected hearing impairment causing sensory isolation (i.e., without appropriate hearing aids)
• Documented end-of-life status in the medical record

Sponsors & Collaborators

• LNA SANTE: lead

Study Sites (1)

Villa Eléonore

Montlouis-sur-Loire, 37270, France

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Behavioral Symptoms; Dementia; Psychomotor Agitation; Behavior; Anxiety Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia

Study Officials

• Sandrine POINTEREAU

  Villa Eléonore - LNA SANTE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)