- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536360
The Effects of Group Music Therapy on the Emotional Health of Residents in Long-Term Care Facilities: A Pilot Study
The goal of this pilot study is to learn whether group music therapy improves the emotional health of residents living in long-term care facilities. It will also examine the feasibility of integrating an artificial intelligence (AI)-based emotion recognition model into routine psychosocial interventions.
The main questions it aims to answer are:
Does group music therapy improve positive affect and reduce negative affect, depression, and loneliness among long-term care residents? Are AI-based facial emotion recognition results consistent with residents' self-reported emotional assessments?
Researchers will use a one-group pretest-posttest quasi-experimental design to evaluate changes before and after a 6-week group music therapy program. The study will also compare subjective questionnaire results with objective facial emotion recognition outputs generated by the PaLI Gemma 2 multimodal model.
Participants will:
Attend one 60-minute group music therapy session per week for 6 weeks Complete emotional health questionnaires before the first session and after the sixth session Be recorded during sessions using a non-invasive camera system for facial emotion analysis Have their questionnaire results compared with AI-based emotion recognition outputs to evaluate consistency and feasibility
This pilot study will provide preliminary evidence regarding both the psychological benefits of group music therapy and the feasibility of applying AI-supported multimodal emotion assessment in long-term care settings.
Study Overview
Status
Intervention / Treatment
Detailed Description
Taiwan is entering a super-aged society, and an increasing number of older adults reside in long-term care (LTC) facilities. Although institutional care provides medical and daily living support, many residents experience loneliness, depressive symptoms, and reduced emotional well-being. Non-pharmacological interventions such as group music therapy have demonstrated beneficial effects on mood regulation, social interaction, and psychological health. However, most previous studies have relied primarily on self-report questionnaires or observer-rated scales, which may be influenced by cognitive status, expressive ability, or assessment bias.
This pilot study aims to evaluate both the psychological effects of group music therapy and the feasibility of integrating an artificial intelligence (AI)-based multimodal emotion recognition model into emotional assessment in LTC settings.
Study Design
This study uses a quasi-experimental one-group pretest-posttest design. Approximately 20 residents from a long-term care facility in central Taiwan will be recruited using convenience sampling.
Inclusion criteria include:
Age 65 years or older
Residency in the facility for at least 3 months
Possesses basic cognitive functions (0-2 errors on the SPMSQ scale)
Ability to participate in group activities
Provision of informed consent for participation and facial image collection
Residents with severe dementia, major psychiatric disorders, neurodegenerative diseases, severe sensory impairments, or recent participation in other psychological or music therapy programs will be excluded.
Intervention
Participants will receive a 6-week group music therapy program. Each participant will attend one 60-minute session per week, for a total of 6 sessions. Sessions will be conducted in small groups (approximately 10 participants per group) and led by a trained music therapist with support from nursing staff and research personnel.
Each session will include:
Music listening using culturally familiar songs
Instrument interaction (e.g., tambourines, hand bells, xylophones)
Singing and vocal expression activities
Short group sharing discussions to promote emotional expression and social connection
The intervention is designed to progressively enhance emotional engagement, social interaction, and psychological comfort in a supportive group environment.
Outcome Measures
Emotional health outcomes will be assessed at two time points:
T0 (baseline): Before the first session
T1 (post-intervention): Within 24 hours after the sixth session
Subjective measures include:
International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)
Geriatric Depression Scale - 15 item version (GDS-15)
UCLA Loneliness Scale Version 3
Barthel Index (functional status, baseline only)
AI-Based Multimodal Emotion Analysis
During each music therapy session, participants' facial images will be captured using a non-invasive camera system under standardized environmental conditions.
The PaLI Gemma 2 multimodal model will analyze static facial images to generate:
Categorical emotion outputs (e.g., happy, sad, angry, fear, surprise, disgust, neutral)
Continuous emotion dimensions (valence and arousal values)
Emotion recognition outputs from Session 1 (baseline representation) and Session 6 (post-intervention representation) will be compared with corresponding subjective questionnaire scores. Correlation analyses (Pearson or Spearman) will examine the consistency and complementary value between AI-based emotion detection and self-reported emotional states.
Statistical Analysis
Descriptive statistics will summarize demographic and baseline characteristics.
Pre-post differences in emotional outcomes will be examined using:
Paired t-tests for normally distributed data
Wilcoxon signed-rank tests for non-normally distributed data
Effect sizes (Cohen's dz or r) and 95% confidence intervals will be reported to support future sample size estimation for larger trials.
Correlation analyses will evaluate agreement between subjective measures and AI-derived emotional indicators.
Ethical Considerations
The study will be approved by an Institutional Review Board (IRB) prior to implementation. Written informed consent will be obtained from all participants. Facial image data will be anonymized and used solely for emotion recognition analysis. No identity recognition will be performed. All data will be securely stored in encrypted databases, and participants may withdraw at any time without affecting their care.
Significance
This pilot study will provide preliminary evidence regarding:
The effectiveness of group music therapy in improving emotional well-being among LTC residents.
The feasibility of integrating AI-based multimodal emotion assessment into long-term care practice.
Findings will inform the development of future large-scale trials and contribute to the advancement of technology-assisted psychosocial care models in aging societ
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taichung City
-
Taichung, Taichung City, Taiwan, 406040
- China Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged 65 years or older
Resident of the long-term care facility for at least 3 months
SPMSQ scale error 0-2 questions
Medically stable and able to participate in group activities
Able to communicate and complete questionnaires (with assistance if needed)
Willing to provide written informed consent, including consent for facial image collection
Exclusion Criteria:
Diagnosed with severe dementia
Diagnosed with major psychiatric disorders
Diagnosed with neurodegenerative diseases that significantly impair participation
Severe hearing or visual impairment that prevents engagement in music therapy activities
Participation in other psychological therapy or music therapy programs within the past 3 months
Acute medical condition requiring hospitalization or intensive treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group Music Therapy Intervention
Arm 1: Group Music Therapy Intervention Participants assigned to this single study arm will receive a 6-week group music therapy program. Each participant will attend one 60-minute session per week, for a total of six sessions. The intervention includes structured music listening, instrument interaction (e.g., percussion instruments), group singing, and brief sharing activities designed to promote emotional expression and social interaction. Sessions will be led by a trained music therapist with support from nursing staff. Participants will complete emotional health questionnaires at baseline (before the first session) and after the sixth session. During sessions, non-invasive facial image recordings will be collected for AI-based emotion analysis. All participants receive the same intervention; there is no control or comparison arm in this pilot study. |
This intervention consists of a structured 6-week group music therapy program designed for residents of a long-term care facility. Participants attend one 60-minute session per week, for a total of six sessions. Sessions are conducted in small groups (approximately 10 participants per group) and are led by a trained music therapist with support from nursing staff. The intervention follows an active music therapy approach and includes four core components: (1) listening to culturally familiar music to evoke emotional resonance; (2) interactive instrument play using simple percussion instruments to promote engagement and coordination; (3) group singing and vocal expression to facilitate emotional expression and social bonding; and (4) brief group sharing discussions to encourage reflection and interpersonal connection. The program is progressively structured to enhance emotional engagement and social interaction in a supportive environment. In addition to standard psychosocial outcome
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Positive Affect Score on the I-PANAS-SF
Time Frame: Baseline, Week 6
|
Assessed using the short form of the International Positive and Negative Affect Schedule (I-PANAS-SF).
The positive affect subscale consists of 5 items rated on a 5-point Likert scale (1=never, 5=always).
Total subscale scores range from 5 to 25, with higher scores indicating stronger positive emotional intensity.
|
Baseline, Week 6
|
|
Change in Negative Affect Score on the I-PANAS-SF
Time Frame: Baseline, Week 6
|
Assessed using the short form of the International Positive and Negative Affect Schedule (I-PANAS-SF).
The negative affect subscale consists of 5 items rated on a 5-point Likert scale (1=never, 5=always).
Total subscale scores range from 5 to 25, with higher scores indicating stronger negative emotional intensity.
|
Baseline, Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geriatric Depression Scale
Time Frame: Baseline, Week 6
|
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15).
It is a yes/no self-report instrument.
Total scores range from 0 to 15, with higher scores indicating greater severity of depressive symptoms.
|
Baseline, Week 6
|
|
UCLA Loneliness Scale
Time Frame: Baseline and Week 6
|
The complete scale consists of 20 items, using a four-point scale (1 = never, 4 = always), with a total score range of 20-80 points.
The score intervals are defined as follows: 20-34 points for low-level loneliness, 35-49 points for moderate loneliness, 50-64 points for high-level loneliness, and 65-80 points for severe loneliness.
|
Baseline and Week 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in AI-Derived Emotional Valence Score
Time Frame: Baseline, Week 6
|
Emotional valence (ranging from negative to positive) will be continuously analyzed using AI software.
Data will be extracted from static facial images captured during the group music therapy sessions.
Scores range from -1 to 1, with higher scores indicating a more positive emotional state.
|
Baseline, Week 6
|
|
Change in Positive Affect Score on the I-PANAS-SF
Time Frame: Baseline, Week 6
|
Assessed using the short form of the International Positive and Negative Affect Schedule (I-PANAS-SF).
The Positive affect subscale consists of 5 items rated on a 5-point Likert scale (1=never, 5=always).
Total subscale scores range from 5 to 25, with higher scores indicating stronger Positive emotional intensity.
|
Baseline, Week 6
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chang, Y.-C. (2026). The Effects of Group Music Therapy on the Emotional Health of Residents in Long-Term Care Facilities: A Pilot Study. Study protocol, China Medical University, Taichung, Taiwan. Unpublished.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMU114-N-27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual Participant Data (IPD) will not be publicly shared due to the sensitive nature of the data collected in this study. The dataset includes psychological assessment results and facial image data used for AI-based emotion recognition analysis. Although all data will be de-identified and coded, the combination of emotional health information and facial image records may pose a potential risk of re-identification.
To protect participant privacy and comply with Institutional Review Board (IRB) regulations and local data protection policies, individual-level data will not be made publicly available. Aggregated, de-identified results may be shared in scientific publications or upon reasonable request for academic collaboration, subject to ethical approval and data use agreements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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