Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Salivary cortisol
研究概览
简要总结
This study is a randomized single-blind controlled trial with parallel arms.The present study is based on that previously published by Pezzati and collegues (2014) and it is part of a larger project focusing on Doll Therapy dissemination in Canton Ticino through team training and supervision and guidelines definition that led to the establishment of the Ticino Doll Therapy Group with support of the Canton Office for elderly and home care.
The first hypothesis regards the 30 days-effectiveness efficacy of the Doll Therapy intervention in reducing symptoms of behavioral disorders (BPSD) that appear in stressful situations (as in the case of a separation from a professional caregiver) and in reducing stress as perceived by the treating physician. Another issue to be investigated is whether the typical way in which a person manifested attachment behaviors during own life (classified in three types of mental states: secure, insecure and unresolved) is associated, once this person is in an advanced stage of dementia, with caregiving behaviors of the PWD during the doll presentation (i.e. caressing the object, talking to it and smiling).
详细描述
Primary goals The primary goal of the present study is to evaluate the efficacy of Doll Therapy Intervention (DTI) versus a Sham Intervention (SI), on behavioral and psychiatric symptoms of PWD living in a nursing home. Outomes will be measured with the Italian version of Neuropsychiatric Inventory-Nursing Home. It is expected an improvement in terms of a decrease in NPI-NH total score.
We will also assess the efficacy of DTI versus SI, on professional caregivers distress ratings related to behavioral and psychiatric symptoms of PWD. It will be measured with the Italian version of NPI-NH. It is expected an improvement in terms of a decrease in NPI-NH distress total score.
It will also assess the efficacy of DTI versus SI, on cognitive and physiological status of PWD. The first will be recorded as the presence or absence of exploratory and caregiving behaviors on an observational grid expressly conceived for this purpose (Grid 2, Appendix). It is expected an improvement in terms of an increase of the number and duration of exploratory and caregiving behaviors. The efficacy of DTI versus SI on physiological status of PWD will be measured by assessing blood pressure (systolic and diastolic), heart rate, and salivary cortisol that are biomarkers of acute stress. It is expected an improvement in terms of a decrease in these parameters.
All evaluations will be performed at baseline (T0) and thirty days later (T1). Secondary goal The secondary goal is to evaluate the stability of attachment behaviors of the PWD through the adminstration of the Adult Attachment Interview to the patients' offspring after conclusion of interventions. It is expected to find an association between the attachment style of the PWD and caregiving behaviors during the doll presentation (i.e. caressing the object, talking to it and smiling). Such behaviors are recorded in an observational grid expressely conceived for this purpose.
These observations will allow the investigators to test wether a relationship between present and past attachment style of PWD and between attachment styles and participant response to doll therapy exist. Investigators expect that PWD with a previous secure attachment style will accept the doll and will show caregiving behaviors, while the PWD with insecure attachment style will show, especially during the first contacts, rejection, avoidance of the doll or excessive caregiving reactions towords the doll. Investigators also expect that PWD with unresolved attachment style will show inconsistent responses to the presentation of the doll, with approaching and rejecting behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
To ensure blinding, the psychologist who will administer the NPI-NH will not be aware of the arm to which the subjects belong.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• presence of moderate to severe dementia, assessed with Global Deterioration Scale (GDS 4-7);
- •presence of at least one behavioral and psychiatric symptom (BPSD) in addition to depression or apathy (Lai, 2014) assessed with the NPI-NH;
- •female gender;
- •admission in the nursing home at least 3 months before;
- •no previous Doll Therapy exposure;
- •presence of a daughter or a son, as a family caregiver
排除标准
- •male gender
- •presence of previous comorbid mental disorders, such as major depression, bipolar disorders and schizophrenia;
- •inability to sit comfortably on a chair or limitations in mobility of the arms;
- •presence of acute clinical conditions interfering with the participation to the study
结局指标
主要结局
Salivary cortisol
时间窗: from the time immediately before to 15 minutes after each daily sessions of DTI or SI
Salivary cortisol is a biomarker of stress, and its secretion is the final product of the activation of stress-response mechanisms, specifically the hypothalamic-pituitary-adrenal axis. It is expected a significantly different decrease of the concentration of salivary cortisol between experimental and control group.
Professional caregiver distress
时间窗: from baseline (T0) to 30 days since the beginning of intervention (T1).
A decrease of the professional caregiver distress ratings related to behavioral and psychiatric symptoms of patient. It is measured as the net change in the distress total score of the Nursing Home version of NPI (NPI-NH-D total score) from baseline to post-intervention.
Interaction with the object
时间窗: from baseline (T0) to 30 days since the beginning of intervention (T1)
An increase of the duration (expressed in seconds) of the interaction with the object: it is expected a significant difference in duration between experimental and control group. This measure is recorded by professional caregivers during the daily sessions of DTI or SI.
Heart rate
时间窗: from baseline (T0) to 30 days since the beginning of intervention (T1).
A significantly different decrease of the heart rate of the patients between experimental and control group.
Blood pressure
时间窗: ffrom the time immediately before to 15 minutes after each daily sessions of DTI or SI
A significantly different decrease of the blood pressure (systolic and diastolic) of the patients between experimental and control group.
Behavioral and psychiatric symptoms
时间窗: from baseline (T0) to 30 days since the beginning of intervention (T1)
A decrease of the behavioral and psychiatric symptoms of patient measured as the net change in the total scores of the Nursing Home version of NPI (NPI-NH total score) from baseline to post-intervention. It is expected a significant difference in NPI-NH total scores between experimental and active control group. The NPI-NH will be administered to the team of the nursing home by a trained blinded psychologist. The NPI-NH is specifically designed for interviewing professional care facility staff.
次要结局
- association between the pre-morbid attachment style of PWD and the response to DTI(after 30 days since the beginning of intervention (T1))