Clinical trial NCT03224143: Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial
Official title: Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: dementia
doll therapy
attachment
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Fondazione Golgi Cenci
name: University of Turin, Italy
name: Gruppo Doll Therapy Ticino
name: Case per Anziani Canton Ticino
name: Centro di Terapia Cognitiva, Como
First posted: 2017-07-21
Enrollment: 128
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will undergo daily sessions of DTI or SI, lasting an hour at most, led by a trained professional caregiver. The DTI involves the presentation of a doll produced by a Swedish brand conceived for Doll Therapy use. The SI group will attend similar daily sessions, but in place of the doll, it will be presented with a non-anthropomorphic object, i.e., a soft foam rubber cube covered with a coloured and velvety textile. The 1st and 30th session of all participants will be videotaped by a trained psychologist as described below. The experimental protocol is described in detail in Pezzati et al. (2014) and it is structured with the goal of recreating a situation of (1) separation from a known figure and (2) interaction with the environment in order to partially recreate the prototypical phases of the "Strange situation" (Ainsworth et al., 1978).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Behavioral and psychiatric symptoms
timeFrame: from baseline (T0) to 30 days since the beginning of intervention (T1)
measure: Professional caregiver distress
timeFrame: from baseline (T0) to 30 days since the beginning of intervention (T1).
measure: Interaction with the object
timeFrame: from baseline (T0) to 30 days since the beginning of intervention (T1)
measure: Salivary cortisol
timeFrame: from the time immediately before to 15 minutes after each daily sessions of DTI or SI
measure: Blood pressure
timeFrame: ffrom the time immediately before to 15 minutes after each daily sessions of DTI or SI
measure: Heart rate
timeFrame: from baseline (T0) to 30 days since the beginning of intervention (T1).
Secondary outcomes:
measure: association between the pre-morbid attachment style of PWD and the response to DTI
timeFrame: after 30 days since the beginning of intervention (T1)
Other outcomes:
Locations:
city: Manno
country: Switzerland
facility: SUPSI
Study officials:
affiliation: University of Applied Sciences and Arts of Southern Switzerland
name: Rita Pezzati
role: PRINCIPAL_INVESTIGATOR
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