[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07419022":3,"trial-entities:NCT07419022":117,"trial-summary:NCT07419022":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":45,"secondary_outcomes":54,"sex":67,"minimum_age":68,"maximum_age":17,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":89,"locations":92,"central_contacts":101,"overall_officials":111,"references":115,"see_also_links":116},"NCT07419022","5K01AG088475-02","Improv Music Therapy for Older Adults","Impact of Improvisation Music Therapy for Persons Living With Dementia and Their Care Partners","NOT_YET_RECRUITING","2028-12","2026-02","2026-02-23","2026-12","University of California, San Francisco","OTHER",false,"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.",null,[19,20],"Alzheimer's Disease (AD)","Older Adults (65 Years and Older)",[22,23,24,25,26,27,28,29],"music","improvisation","person living with dementia","caregiver","Alzheimer's Disease and related diseases","mechanism of behavior change","stress reduction","behavior change","INTERVENTIONAL","SUPPORTIVE_CARE",[33],"NA",{"count":35,"type":36},40,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Clinical Improvisation","Clinical improvisation music therapy offered as group sessions delivered by board-certified music therapist.",[43,44],"Group A","Group B",[46,50],{"measure":47,"description":48,"timeFrame":49},"Science of Behavior Change (SOBC) Brief-COPE","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).","Baseline and Post-Intervention, 8 weeks",{"measure":51,"description":52,"timeFrame":53},"SOBC Perceived Stress Scale","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)","Baseline and Post Intervention, 8 weeks",[55,58,61,64],{"measure":56,"description":57,"timeFrame":53},"Dementia Mood Picture Test","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.",{"measure":59,"description":60,"timeFrame":53},"SOBC Positive and Negative Affect (PANAS)","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.",{"measure":62,"description":63,"timeFrame":53},"Neuropsychiatric Inventory (NPI-Q)","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).",{"measure":65,"description":66,"timeFrame":49},"Kingston Caregivers STress Scale","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)","ALL","60 Years",true,{"inclusion":71,"exclusion":80,"raw_text":88},[72,73,74,75,76,77,78,79],"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)","Age 18 or Older","Moderate to good English fluency (self-rated English fluency)","Willing to participate in intervention with PLWD",[81,82,83,84,85,86,83,87],"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","Current but not prior severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)","Plans to move out of the area","Inclusion Criteria\n\nInclusion criteria for the Person Living with Dementia (PLWD) are:\n\n* Age 60 and over, living independently in the community\n* Medical diagnosis of Alzheimer's Disease\n* Mild dementia defined as MoCA score between 16-20, or MMSE score between 19-24\n* Sufficient visual and hearing acuity (age-related to normal hearing loss with assistive devices)\n* English fluency rated fairly well to well (self-rated English fluency)\n\nInclusion Criteria for Caregiver are:\n\n* Age 18 or Older\n* Moderate to good English fluency (self-rated English fluency)\n* Willing to participate in intervention with PLWD\n\nExclusion Criteria\n\nExclusion criteria for PLWD are:\n\n* Medical diagnosis of severe dementia (any etiology)\n* Non-AD dementia diagnosis (e.g., frontotemporal dementia)\n* 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\n* Significant difficulty moving the hands or arms (severe arthritis, neuropathy)\n* Plans to move out of the area within six months\n\nExclusion criteria for Caregiver are:\n\n* Current but not prior severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)\n* 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\n* Plans to move out of the area",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":13,"city":94,"state":95,"zip":96,"country":97,"geoPoint":98},"San Francisco","California","94158","United States",{"lat":99,"lon":100},37.77493,-122.41942,[102,107],{"name":103,"role":104,"phone":105,"email":106},"Karen C Barrett, PhD","CONTACT","4153534501","Karen.Barrett@ucsf.edu",{"name":108,"role":104,"phone":109,"email":110},"Howie Rosen, MD","]415 476-5567","howie.rosen@ucsf.edu",[112],{"name":113,"affiliation":13,"role":114},"Karen Barrett, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Alzheimer's Disease",[],{"nct_id":4,"found":69,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This study is an interventional study planning to enroll 40 participants. It is not specified if it is randomized or blinded.","completed","Improv Music Therapy for Older Adults with Alzheimer's Disease","This study is exploring whether \"Clinical Improvisation\" music therapy can help older adults (60 years and older) who have mild Alzheimer's Disease. This therapy involves group sessions led by a board-certified music therapist. The researchers want to see if participating in these sessions can improve mood, stress levels, and emotions. You would be eligible if you are 60 or older, live independently, have a medical diagnosis of Alzheimer's with mild dementia, and have sufficient sight and hearing. The study plans to enroll 40 participants, but its current recruitment status is unclear.","Participants will be assessed at baseline and after 8 weeks, which is the end of the intervention period. No further follow-up is specified.",91,"You and your care partner would participate in music therapy sessions for about 8 weeks. You would also fill out questionnaires about your mood, stress, and emotions at the beginning and end of the 8-week period.","Not stated in the trial record.",[40],"v2"]