Background: 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. Discussion: 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. Trial registration: ClinicalTrials.gov, ID: NCT03224143. Retrospectively registered on

Background: Doll therapy (DT) is a non-pharmacological intervention for the treatment of the behavioural and psychological symptoms of dementia (BPSD). We designed a single-blind randomized controlled trial of the 30-day efficacy of DT in reducing the BPSD, professional caregivers’ distress and patients’ biomarkers of stress, and in improving the exploration and caregiving behaviours. Methods: We randomly assigned 134 women with moderate-to-severe dementia living in nursing homes (NHs) to a DT intervention (DTI, 67) or a sham intervention with a cube (SI, 67). Results: From the first to the 30th session, the DTI group showed a significant decrease in the Neuropsychiatric Inventory-NH (NPI-NH) total score and in the NPI-NH-Distress score compared to the SI group (both p < 0.001). We observed a greater interest in the doll than in the cube, a greater acceptance of a separation from the nurse among DTI participants, and caregiving and exploratory behaviours towards the doll. There were no differences between the groups in the stress biomarkers. Conclusions: Consistent with attachment theory, our findings support the 30-day efficacy of DT, as this non-pharmacological intervention promotes perceptions of security by creating a situation in which patients feel confident and engaged in a caregiving relationship with the doll and reduces the challenging behaviours that are stressful for professional caregivers.

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Background Doll therapy (DT) is a non‐pharmacological intervention recommended for the treatment of behavioural and psychological symptoms of dementia (BPSD), producing benefits on agitation, aggression and wandering. By recognition of the doll as a real baby, challenging behaviours, viewed as requests for care and protection (i.e. attachment behaviours), are replaced with caregiving behaviors. In order to overcome methodological issues of the available studies, we have designed a single‐blind randomised controlled trial on efficacy of DT in managing BPSD and reducing professional caregivers’ perceived stress linked to BPSD (ClinicalTrials.gov, NCT03224143). Method The object presentation procedure (doll or cube, a non‐anthropomorphic object) is structured with the goal of recreating a situation of separation from a known figure and interaction with the environment in order to partially recreate the prototypical phases of the ‘strange situation’. Analysis of covariance (ANCOVA) compared the intervention group and the active control group on the net change (post‐treatment minus pre‐treatment) in NPI‐NH total score and NPI‐NH Distress score. Pre‐treatment NPI‐NH total score and psychotropic medications were used as covariates in these analyses. Result One hundred thirty‐four women living in 26 nursing homes in the Canton Ticino area (Switzerland) were randomized, 129 completed the study. The intervention group (n= 64) and the active control group (n= 65) were comparable: age [(mean (SD)=86.9 (5.9) and mean (SD)=88.4 (5.5), respectively; z=‐1.276, p=0.202)], baseline NPI‐NH total score [(mean (SD)=33.84 (13.28) and mean (SD)= 31.55 (12.1), respectively; z=‐1.05; p=0.292)], baseline NPI‐NH‐Distress total score [(mean (SD)=12.08 (5.4) and mean (SD)=10.6 (5.04), respectively; z=‐1.86, p=0.063), Global Deterioration Scale score [(mean (iqr)=6 (5‐7) and mean (iqr)=6 (5‐7), respectively; z=‐1.146, p=0.252). Based on ANCOVA results, the intervention group reported a significantly higher decrease on NPI‐NH total score [(adjusted mean (SE)=‐ 11,63 (1,0)] with respect to the active control group [adjusted mean (SE)=‐ 4.19 (1.0); F(1)=43.433, p=<0.001; Partial 2=0.638]. The intervention group reported a significantly higher decrease on NPI‐NH‐Distress score [(adjusted mean (SE)=‐ 3.71 (0.43)] with respect to the active control group [(adjusted mean (SE)=‐1.24 (0.43); F(1)=40.97, p=<0.001; Partial 2=0.625]. Conclusion DT significantly reduces challenging behaviors and caregivers’ perceived stress linked to BPSD.

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