Golgi Cenci Foundation, Corso San Martino 10, 20081, Abbiategrasso, Italy.
Dipartimento di Economia Aziendale e Socio Sanitaria (SUPSI), Centro Competenza Anziani, Manno, Switzerland.
Trials. 2020 Feb 3;21(1):133. doi: 10.1186/s13063-020-4050-8.
Doll therapy is a non-pharmacological intervention for people with dementia aimed to reduce distressing behaviours. Reliable results on the efficacy of Doll therapy for people with dementia are needed. The concept of attachment theorised by Bowlby has been proposed to explain the Doll therapy process, but it has not been proven to influence the response to doll presentation.
METHODS/DESIGN: This single-blind, randomised controlled trial will involve people with dementia living in nursing homes of the Canton Ticino (Switzerland). Participants will be randomised to one of two interventions: Doll Therapy Intervention or Sham Intervention with a non-anthropomorphic object, using a 1:1 allocation ratio. The two interventions will consist of 30 daily sessions lasting an hour at most, led by a trained nurse for an hour at most. We will enrol 64 participants per group, according to power analysis using an estimated medium effect size (f = 0.25), an alpha level of 0.05, and a power of 0.8. The primary goal is to test the efficacy of the Doll Therapy Intervention versus the Sham Intervention as the net change in the following measures from baseline to 30 days (blinded outcomes): the Neuropsychiatric Inventory-Nursing Home administered by a trained psychologist blinded to group assignment, the professional caregivers' perceived stress scale of the Neuropsychiatric Inventory-Nursing Home, patients' physiological indices of stress (salivary cortisol, blood pressure and heart rate) and interactive behaviours. The secondary goal is to assess the relationship between attachment styles of people with dementia (detected by means of the Adult Attachment Interview to the patients' offspring) and their caregiving behaviours shown during the Doll Therapy Intervention.
This is the first single-blind, randomised controlled trial on the efficacy of Doll therapy for dementia and an explanatory model of the response of people with dementia to doll presentation.
ClinicalTrials.gov, ID: NCT03224143. Retrospectively registered on 21 July 2017.
玩偶疗法是一种针对痴呆症患者的非药物干预措施，旨在减少困扰行为。需要可靠的结果来证明玩偶疗法对痴呆症患者的疗效。鲍尔比提出的依恋理论概念被用来解释玩偶疗法的过程，但它尚未被证明会影响对玩偶呈现的反应。
方法/设计：这项单盲、随机对照试验将涉及居住在提契诺州（瑞士）养老院的痴呆症患者。参与者将被随机分配到两种干预措施之一：玩偶疗法干预或使用非拟人化物体的假干预，采用 1:1 分配比例。两种干预措施将包括每天最多 30 次、每次最多 1 小时的疗程，由经过培训的护士进行最多 1 小时的指导。我们将根据使用估计的中等效应大小（f=0.25）、α 水平为 0.05 和功效为 0.8 的功效分析，每组招募 64 名参与者。主要目标是测试玩偶疗法干预与假干预的疗效，即从基线到 30 天的以下措施的净变化（盲法结果）：由受过训练的心理学家进行的经盲法分组的神经精神疾病-养老院护理员评定量表、神经精神疾病-养老院护理员的专业护理人员感知压力量表、患者的应激生理指标（唾液皮质醇、血压和心率）和互动行为。次要目标是评估痴呆症患者的依恋风格（通过对患者子女进行成人依恋访谈来检测）与他们在玩偶疗法干预期间表现出的护理行为之间的关系。
这是第一项针对痴呆症玩偶疗法疗效的单盲、随机对照试验，也是痴呆症患者对玩偶呈现反应的解释模型。
ClinicalTrials.gov，编号：NCT03224143。于 2017 年 7 月 21 日进行回顾性注册。
