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NCT Number: NCT07419022

Improv Music Therapy for Older Adults

Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. During the music therapy sessions, they may be observed or asked questions about the music therapy sessions.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for the Person Living with Dementia (PLWD) are:

  • Age 60 and over, living independently in the community
  • Medical diagnosis of Alzheimer's Disease
  • Mild dementia defined as MoCA score between 16-20, or MMSE score between 19-24
  • Sufficient visual and hearing acuity (age-related to normal hearing loss with assistive devices)
  • English fluency rated fairly well to well (self-rated English fluency)

Inclusion criteria

for Caregiver are:

  • Age 18 or Older
  • Moderate to good English fluency (self-rated English fluency)
  • Willing to participate in intervention with PLWD

Exclusion criteria

Exclusion criteria

for PLWD are:

  • Medical diagnosis of severe dementia (any etiology)
  • Non-AD dementia diagnosis (e.g., frontotemporal dementia)
  • Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study
  • Significant difficulty moving the hands or arms (severe arthritis, neuropathy)
  • Plans to move out of the area within six months

Exclusion criteria

for Caregiver are:

  • Current but not prior severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
  • Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study
  • Plans to move out of the area

Treatment and study plan

Clinical Improvisation

Behavioral

Clinical improvisation music therapy offered as group sessions delivered by board-certified music therapist.

Primary outcomes

  1. Science of Behavior Change (SOBC) Brief-COPE

    Time frame: Baseline and Post-Intervention, 8 weeks

    The Brief COPE is a 28 item measure of strategies used for coping or regulating cognitions in response to stressors. The questions assess the frequency with which a person uses different coping strategies (e.g. "I've been turning to work or other activities to take my mind off strings") and the respondent gives a rating on a 5 item scale (1= I haven't been doing this at all to 4 I've been doing this a lot).

  2. SOBC Perceived Stress Scale

    Time frame: Baseline and Post Intervention, 8 weeks

    The Perceived Stress Scale ask participants about their feelings and thoughts during the last month. There are 10 items and participants are asked how often they felt orr thought a certian way (0 = never to 4 very often)

Secondary outcomes

  1. Dementia Mood Picture Test

    Time frame: Baseline and Post Intervention, 8 weeks

    Participants are given large line face drawings with large font descriptors. Participants are asked whether or not they are experiencing each mood ("Are you in a good mood?") and the intensity of the mood. The test assesses the PLWD directly but focuses on six primary moods.

  2. SOBC Positive and Negative Affect (PANAS)

    Time frame: Baseline and Post Intervention, 8 weeks

    The PANAS is a 20 item self-questionnaire. Respondent is asked to read several words which describe different feelings and emotions. Applicability of the emotion is scored by respondent on a 5 point Likert Scale (1 = very slightly or not at all to 5 = extremely). Higher scores on Positive Affect items incidate greater intensity of positive emotions and higher scores on Negative Affect indicate greater intensity of negative emotions.

  3. Neuropsychiatric Inventory (NPI-Q)

    Time frame: Baseline and Post Intervention, 8 weeks

    The NPI-Q is a 12-item questionnaire completed by the caregiver. Each question asks about a neuropsychiatric symptom over the previous month. The Caregiver can say "no" and go on to the next question. If the Caregiver says "yes", the caregive then rates the a) Severity of the symptoms present on a 3 point scale (1=mild to 3 = severe), and b) Distress experienced by the caregiver due to that symptom on a 5 point scale (0 = not distressing at all to 5 very distressing).

  4. Kingston Caregivers STress Scale

    Time frame: Baseline and Post-Intervention, 8 weeks

    The KCSS is at 10 item questionnaire completed by a family caregiver. The questions ask caregivers to report feeling of stress surrounding specific aspects of caregiving. Caregivers respond using a 5 point scale (1 = no stress to 5 = extreme stress)

Study contacts

Contact information is provided by the study sponsor or research team.

Howie Rosen, MD

CONTACT

[email protected]

]415 476-5567

Karen C Barrett, PhD

CONTACT

[email protected]

4153534501

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Impact of Improvisation Music Therapy for Persons Living With Dementia and Their Care Partners

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 18, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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