The Impact of a Caregiver-patient Music Intervention on Social Attention and Connectedness in Persons Living With bvFTD and AD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mutuality Scale
研究概览
简要总结
This is an exploratory mixed-methods control-treatment study to evaluate if participation in rhythmic musical activities improves social attention and connectedness in individuals living with mild to moderate bvFTD and AD, and their caregivers. Secondary objectives include evaluating the potential relationships between brain networks associated with rhythm production, social attention, and connectedness in these populations.
详细描述
The proposed research will evaluate potential relationships between synchronous rhythm production, social attention, and connectedness in persons living with mild to moderate bvFTD and AD and their caregivers. To evaluate these relationships, the proposed research will include data collection and analysis of the following: 1) pre-post evaluation of social attention and connectedness in individuals living with dementia and their caregivers; 2) control-treatment participation in a synchronous (treatment) or solo (control) rhythm production activity; and 3) secondary analysis of structural and functional MRI of resting state network connectivity between networks of the brain including areas associated with rhythm perception and production, namely the fronto-parietal, executive control, sensorimotor, dorsal and ventral attention networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion (patients)
- •Male or female ≥ 55 years of age living with bvFTD; or ≥ 70 years of age living with AD.
- •Documentation of a bvFTD or AD diagnosis as evidenced by one or more known clinical features.
- •Written informed consent obtained from subject.
- •Inclusion (caregivers)
- •Male or female ≥ 55 years of age living without diagnosis of neurological or psychiatric disease.
- •Individual capable of independent execution of activities of daily living, including personal care and hygiene, dressing, eating, use of a toilet, and mobility.
- •Written informed consent.
- •Exclusion (patients)
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •community-dwelling individuals not living with bvFTD
- •community-dwelling individuals with normal cognitive functioning
- •Individuals living with Alzheimer's disease or related dementias (primary progressive aphasia, semantic variant FTD, Lewy body dementia, vascular dementia, Parkinson's disease, or mixed dementia)
- •Individuals with a score of 2 or higher on the CDR
- •Individuals with a history of neuropsychiatric illness that would interfere with performance (e.g., transient psych hx of depression okay, hx of schizophrenia will be excluded) or medicated depression to control symptoms.
- •Individuals with unstable (e.g., cancer other than basal cell skin) or chronic (e.g., severe diabetes) medical conditions
- •Individuals with MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI)
- •Individuals with physical impairment(s) precluding motor response
- •Individuals with inability to walk two blocks without stopping
- •Individuals with hearing or vision deficits that will not allow for completion of testing; inability to hear conversation conducted at an average volume (~60 dB)
- •Individuals who practice music making or production for at least 30-mins per week
- •This may include instrumental or vocal, writing or arranging, alone or in groups
- •Listening to music for more than 30-mins weekly will not exclude the individual from the study
- •Exclusion (Caregivers)
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Community-dwelling individuals living with diagnosis of a neurological or psychiatric disease
- •o Community-dwelling individuals with abnormal cognitive functioning
- •Individuals living with dementia
- •Individuals with a history of neuropsychiatric illness that would interfere with performance (e.g., transient psych hx of depression okay, hx of schizophrenia will be excluded) or medicated depression to control symptoms
- •Individuals with unstable (e.g., cancer other than basal cell carcinoma) or chronic (e.g., severe diabetes) medical conditions
- •Individuals with physical impairment(s) precluding motor control
- •Individuals with inability to walk two blocks without stopping
- •Individuals with hearing or vision deficits that will not allow for completion of testing; inability to hear conversation conducted at an average volume (~60 dB)
- •Individuals who practice music making or production for at least 30-mins per week
- •This may include instrumental or vocal, writing or arranging, alone or in groups
- •Listening to music for more than 30-mins weekly will not exclude the individual from the study
排除标准
- 未提供
研究组 & 干预措施
Solo Rhythm Production
Participants randomized to the control condition will complete the same rhythm conditions to the same recorded audio tracks described in the experimental condition. However, they will not interchange their tapping with their caregiver. They will participate in the rhythm task as a solo producer.
干预措施: Solo Rhythm Production (Behavioral)
Synchronous Rhythm Production
The treatment group will take part in a dyad-based musical rhythm production activity facilitated by a trained musician. This activity will involve two rhythm conditions. The first condition requires tapping along to one pre-recorded audio track composed of an ensemble of Brazilian percussion instruments. The second condition requires tapping along with prerecorded audio tracks of rhythms progressively increasing in difficulty. Participants who indicate proficiency in learning to tap along in both conditions will be able to progress to more complex rhythms. All tapping data will be gathered through a Roland digital hand percussion controller.
干预措施: Synchronous Rhythm Production (Behavioral)
结局指标
主要结局
Mutuality Scale
时间窗: Baseline, 2-weeks
A 15-item instrument using a 0-4 Likert (0 = not at all … 4 = a great deal) that measures mutuality from the caregiver perspective. Examples include "How close do you feel to the person you care for?" or "How much do you confide in the person you care for?"
Social Attention (TASIT)
时间窗: Baseline, 2-weeks
Dependent Variable. Change in social attention will be measured by the TASIT, a 16-item instrument that measures social attention from the care recipient perspective. Items are sectioned by emotion recognition, social inference minimum (sarcasm) or enriched (lies) and assessed using standardized yes-no questions at the end of each section based on four types: think, feel, say, or do.
Degree of rhythmic synchronization between dyad-pairs as determined by autocorrelated inter-tap intervals
时间窗: Through study completion, an average of one year
Independent variable. Degree of rhythmic synchronization will be measured via a musical instrument, digital interface (MIDI) and assessed using an automated data analysis tool created explicitly for the purposes of this study.
Caregiver perceived connectedness questionnaire
时间窗: Baseline, 2-weeks
A 1-item, 1-7 Likert based scale (1 = very disconnected ... 7 = very connected)
Zarit burden
时间窗: Baseline, 2-weeks
A 12-item instrument using a 0-4 Likert (0 = never … 4 = nearly always) that measures burden from the caregiver perspective. An example is "Do you feel that your social life has suffered because you are caring for your relative?"
Positive and Negative Experience
时间窗: Baseline, 2-weeks
A 12-item instrument using a 1-5 Likert (1 = very rarely or never … 5 = very often or always) that measures an overall affect score that can also be divided into positive and negative feelings. It measures how the participant has felt over the past 4-weeks.
Positive Aspects of Caregiving
时间窗: Baseline, 2-weeks
A 9-item instrument using a 1-5 Likert (1 = disagree a lot … 5 = agree a lot) that measures a caregiver's perceptions of their positive experiences in caregiving for their care recipient. An example is "Providing help to \[enter name of care recipient\] has made me feel more useful."
Trait Empathy (Interpersonal Reactivity Index)
时间窗: Baseline
A 28-item instrument using an A-E Likert (A = does not describe me well … E = describes me very well) that measures participants' trait empathic disposition. Four dimensions of trait empathy are used: fantasy scale, empathic concert, perspective taking, and personal distress.
Patient Health
时间窗: Baseline, 2-weeks
A 2-item instrument using a 0-3 Likert (0 = not at all … 3 = nearly every day) that measures participants' perceived depression over the last 2-weeks.
Revised Self-Monitoring
时间窗: Baseline, 2-weeks
A 13-item instrument using a 1-5 Likert (1 = … 5 = ) to measure socioemotional sensitivity and responsiveness to the behavioral expressions of others. An example is "In conversations, the subject is sensitive to even the slightest change in the facial expression of the other person he/she is conversing with."
Self-Compassion
时间窗: Baseline, 2-weeks
A 12-item instrument using a 1-5 Likert (1 = almost never … 5 = almost always) to measure an individual's self-compassion. An example is "When I fail at something important to me I become consumed by feelings of inadequacy."
Inclusion of Self in Other
时间窗: Baseline, 2-weeks
A 7-item instrument using concentric circles (1 = no overlap … 7 = most overlap) to measure an individual's perceived relationship between self to other.
Social Attention (TASIT)
时间窗: Baseline, 2-weeks
Dependent Variable. Change in social attention will be measured by the TASIT, a 16-item instrument that measures social attention from the care recipient perspective. Items are sectioned by emotion recognition, social inference minimum (sarcasm) or enriched (lies) and assessed using standardized yes-no questions at the end of each section based on four types: think, feel, say, or do.
Mutuality Scale
时间窗: Baseline, 2-weeks
A 15-item instrument using a 0-4 Likert (0 = not at all … 4 = a great deal) that measures mutuality from the caregiver perspective. Examples include "How close do you feel to the person you care for?" or "How much do you confide in the person you care for?"
Degree of rhythmic synchronization between dyad-pairs as determined by autocorrelated inter-tap intervals
时间窗: Through study completion, an average of one year
Independent variable. Degree of rhythmic synchronization will be measured via a musical instrument, digital interface (MIDI) and assessed using an automated data analysis tool created explicitly for the purposes of this study.
Self-Compassion
时间窗: Baseline, 2-weeks
A 12-item instrument using a 1-5 Likert (1 = almost never … 5 = almost always) to measure an individual's self-compassion. An example is "When I fail at something important to me I become consumed by feelings of inadequacy."
Caregiver perceived connectedness questionnaire
时间窗: Baseline, 2-weeks
A 1-item, 1-7 Likert based scale (1 = very disconnected ... 7 = very connected)
Trait Empathy (Interpersonal Reactivity Index)
时间窗: Baseline
A 28-item instrument using an A-E Likert (A = does not describe me well … E = describes me very well) that measures participants' trait empathic disposition. Four dimensions of trait empathy are used: fantasy scale, empathic concert, perspective taking, and personal distress.
Inclusion of Self in Other
时间窗: Baseline, 2-weeks
A 7-item instrument using concentric circles (1 = no overlap … 7 = most overlap) to measure an individual's perceived relationship between self to other.
Zarit burden
时间窗: Baseline, 2-weeks
A 12-item instrument using a 0-4 Likert (0 = never … 4 = nearly always) that measures burden from the caregiver perspective. An example is "Do you feel that your social life has suffered because you are caring for your relative?"
Patient Health
时间窗: Baseline, 2-weeks
A 2-item instrument using a 0-3 Likert (0 = not at all … 3 = nearly every day) that measures participants' perceived depression over the last 2-weeks.
Positive and Negative Experience
时间窗: Baseline, 2-weeks
A 12-item instrument using a 1-5 Likert (1 = very rarely or never … 5 = very often or always) that measures an overall affect score that can also be divided into positive and negative feelings. It measures how the participant has felt over the past 4-weeks.
Positive Aspects of Caregiving
时间窗: Baseline, 2-weeks
A 9-item instrument using a 1-5 Likert (1 = disagree a lot … 5 = agree a lot) that measures a caregiver's perceptions of their positive experiences in caregiving for their care recipient. An example is "Providing help to \[enter name of care recipient\] has made me feel more useful."
Revised Self-Monitoring
时间窗: Baseline, 2-weeks
A 13-item instrument using a 1-5 Likert (1 = … 5 = ) to measure socioemotional sensitivity and responsiveness to the behavioral expressions of others. An example is "In conversations, the subject is sensitive to even the slightest change in the facial expression of the other person he/she is conversing with."
次要结局
- Patient resting state functional connectivity (RSFC)(From date of completion of collection of all primary outcome measures, assessed up to 24 months)
- Perceptions of relationship quality between participants as determined by word frequency analysis of semi-structured interview data(From date of completion of collection of all primary outcome measures, assessed up to 24 months)