Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial (ADTS)

University of Applied Sciences and Arts of Southern Switzerland

Status: Unknown

Conditions: Dementia

Treatments: Behavioral: active control group (SI); Behavioral: Doll Therapy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03224143

CE3140 BASEC2016-01992

Details and patient eligibility

About

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).

Full 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.

Enrollment: 128 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Doll Therapy Intervention (DTI)

Experimental group

Description:

The DTI involves the presentation of a doll produced by a Swedish brand and conceived for Doll Therapy use. It is designed to recreate the sensation of touching, looking and holding a child in the arms. The doll presentation involves five standard steps: 1. A nurse (whom the patient knows) accompanies the patient in the room and invites her to sit on the chair. 2. The nurse presents the object (doll or cube) to the patient. 3. The nurse leaves the patient alone with the object. 4. Interaction with the object: it lasts 3 minutes starting from the moment when the nurse leaves the room. This phase is interrupted if the patient drops the object before the time limit. 5. The nurse returns into the room and takes back the object.

Treatment:

Behavioral: Doll Therapy Intervention

Active control group (SI)

Active Comparator group

Description:

The SI involves the presentation of a non-anthropomorphic object, a soft foam rubber cube covered with a coloured and velvety textile. The procedure is the following: 1. A nurse (whom the patient knows) accompanies the patient in the room and invites her to sit on the chair. 2. The nurse presents the cube to the patient. 3. The nurse leaves the patient alone with the cube. 4. Interaction with the cube: it lasts 3 minutes starting from the moment when the nurse leaves the room. This phase is interrupted if the patient drops the object before the time limit. 5. The nurse returns into the room and takes back the cube.

Treatment:

Behavioral: active control group (SI)