AzTrials
AzTrials

LonelinessNCT07536360

The Effects of Group Music Therapy on the Emotional Health of Residents in Long-Term Care Facilities: A Pilot Study

A study testing Group Music Therapy in people with Loneliness and Negative Affect, run by Yu Chia Chang at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Loneliness, Negative Affect, Music Therapy
What is being tested?
Group Music Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTaiwan
Study dates
18 Feb 2026to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • China Medical University

    Taichung, Taichung City, 406040

Other trials in Taiwan

About this 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:

Read more

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.

Read the 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

Being tested
Group Music Therapy
Keywords
Music Therapy, Long-Term Care Facility, Emotion Recognition, Emotional Health
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Music TherapyOther

    Also called Non-pharmacological Music Intervention

    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

Study groups in NCT07536360
Study groupRoleWhat they receive
Group Music Therapy InterventionOtherArm 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.
Receives: Other: Group Music Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Positive Affect Score on the I-PANAS-SF

    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.

    Measured: Baseline, Week 6

  2. Change in Negative Affect Score on the I-PANAS-SF

    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.

    Measured: Baseline, Week 6

Secondary outcomes (2)
  1. Geriatric Depression Scale

    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.

    Measured: Baseline, Week 6

  2. UCLA Loneliness Scale

    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.

    Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start18 Feb 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This study uses a single-arm, quasi-experimental, one-group pretest-posttest interventional design. All enrolled participants will receive the same 6-week group music therapy intervention. Emotional health outcomes will be measured before the intervention (baseline, T0) and after completion of the intervention (post-intervention, T1). There is no control or comparison group in this pilot study. The primary purpose is to evaluate preliminary intervention effects and assess feasibility, including the integration of AI-based facial emotion recognition with subjective self-report measures. The study is designed as an early-phase feasibility and proof-of-concept investigation to generate effect size estimates and methodological insights for future randomized controlled trials.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07536360
Sponsor's protocol ID
CMU114-N-27
Status last verified
Apr 2026
First submitted
17 Mar 2026
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

Questions about this trial

What is this clinical trial studying?

A study testing Group Music Therapy in people with Loneliness and Negative Affect, run by Yu Chia Chang at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Positive Affect Score on the I-PANAS-SF (time frame: Baseline, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07536360, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in