Doll therapy intervention for women with dementia living in nursing homes: a randomized single-blind controlled trial protocol.

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 21 July 2017.

Dysfunction of the social brain in schizophrenia is modulated by intention type: an fMRI study.

In this fMRI study, we investigated theory of mind (ToM) in patients with paranoid schizophrenia. We hypothesized that the network supporting the representation of intentions is dysfunctional in patients with schizophrenia dependent on the type of intention involved. We used a paradigm including a control condition (physical causation) and three intention conditions (private intention, prospective social intention and communicative intentions) differing in the degree of social interaction. In all four experimental conditions patients performed worse than controls regarding accuracy and reaction time. They showed significantly less activation in three regions typically activated in ToM tasks, i.e. paracingulate cortex and bilateral temporo-parietal junctions. However, this dysfunction was dependent on the type of intention represented, i.e. was present only for social but not for non-social intentions. Moreover, part of the reduced activation was related to the fact that there was no signal drop in these regions for the physical causality condition as usually found in controls. This may be due to the tendency of schizophrenic patients to attribute intentionality to physical objects. Our findings have implications for the study and understanding of ToM in schizophrenia but also in other disorders like autism.