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

July 18, 2017 updated by: University of Applied Sciences and Arts of Southern Switzerland

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doll Therapy Intervention (DTI)

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.
Behavioral: Doll Therapy Intervention
Daily sessions, lasting an hour, will take place in a room known to patients (P). The only people in the room will be a nurse (N) and the researcher with video-tape, never interacting with P. The procedure is: the N will accompany the P in the room and the P will take a seat. The N will put the doll in front of the P and will say "Good morning Mr./Mrs....look", with a quiet voice. If the P will not take it at the first attempt, the N will sit down in front of her holding the doll in the arms and will wait for 2 minutes. The N will invite the PWD again. If the P will not take the doll after the second request, the N will not insist and she will leave. If the doll will be taken, the N will leave the P and say "I have to go, goodbye Mr./Mrs. . . ..". The gaze will always be upon the P.
Active Comparator: Active control group (SI)

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.
Behavioral: active control group (SI)
Daily sessions, lasting an hour, will take place in a room known to patients (P). The only people in the room will be a nurse (N) and the researcher with video-tape, never interacting with P. The procedure is: the N will accompany the P in the room and the P will take a seat. The N will put the cube in front of the P and will say "Good morning Mr./Mrs....look", with a quiet voice. If the P will not take it at the first attempt, the N will sit down in front of her holding the cube in the arms and will wait for 2 minutes. The N will invite the PWD again. If the P will not take the cube after the second request, the N will not insist and she will leave. If the cube will be taken, the N will leave the P and say "I have to go, goodbye Mr./Mrs. . . ..". The gaze will always be upon the P.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral and psychiatric symptoms
Time Frame: from baseline (T0) to 30 days since the beginning of intervention (T1)
A decrease of the behavioral and psychiatric symptoms of patient measured as the net change in the total scores of the Nursing Home version of NPI (NPI-NH total score) from baseline to post-intervention. It is expected a significant difference in NPI-NH total scores between experimental and active control group. The NPI-NH will be administered to the team of the nursing home by a trained blinded psychologist. The NPI-NH is specifically designed for interviewing professional care facility staff.
from baseline (T0) to 30 days since the beginning of intervention (T1)
Professional caregiver distress
Time Frame: from baseline (T0) to 30 days since the beginning of intervention (T1).
A decrease of the professional caregiver distress ratings related to behavioral and psychiatric symptoms of patient. It is measured as the net change in the distress total score of the Nursing Home version of NPI (NPI-NH-D total score) from baseline to post-intervention.
from baseline (T0) to 30 days since the beginning of intervention (T1).
Interaction with the object
Time Frame: from baseline (T0) to 30 days since the beginning of intervention (T1)
An increase of the duration (expressed in seconds) of the interaction with the object: it is expected a significant difference in duration between experimental and control group. This measure is recorded by professional caregivers during the daily sessions of DTI or SI.
from baseline (T0) to 30 days since the beginning of intervention (T1)
Salivary cortisol
Time Frame: from the time immediately before to 15 minutes after each daily sessions of DTI or SI
Salivary cortisol is a biomarker of stress, and its secretion is the final product of the activation of stress-response mechanisms, specifically the hypothalamic-pituitary-adrenal axis. It is expected a significantly different decrease of the concentration of salivary cortisol between experimental and control group.
from the time immediately before to 15 minutes after each daily sessions of DTI or SI
Blood pressure
Time Frame: ffrom the time immediately before to 15 minutes after each daily sessions of DTI or SI
A significantly different decrease of the blood pressure (systolic and diastolic) of the patients between experimental and control group.
ffrom the time immediately before to 15 minutes after each daily sessions of DTI or SI
Heart rate
Time Frame: from baseline (T0) to 30 days since the beginning of intervention (T1).
A significantly different decrease of the heart rate of the patients between experimental and control group.
from baseline (T0) to 30 days since the beginning of intervention (T1).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association between the pre-morbid attachment style of PWD and the response to DTI
Time Frame: after 30 days since the beginning of intervention (T1)
The Adult Attachment Interview (AAI) is a semi-structured interview administered to children of the patients in the DTI group in order to identify mental states related to attachment style. Since a correspondence of 75% between the individual's attachment and that of the own children has been reported, the AAI is a useful instrument to recognize the pre-morbid attachment style of patient. It is video-recorded, and the labeling of the answers is carried out by an external trained and authorized psychologist. it is expected a significant association between the pre-morbid attachment style of patient and the response to DTI.
after 30 days since the beginning of intervention (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Applied Sciences and Arts of Southern Switzerland

Collaborators

University of Turin, Italy
Fondazione Golgi Cenci
Gruppo Doll Therapy Ticino
Case per Anziani Canton Ticino
Centro di Terapia Cognitiva, Como

Investigators

  • Principal Investigator: Rita Pezzati, University of Applied Sciences and Arts of Southern Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Anticipated)

February 16, 2020

Study Completion (Anticipated)

February 16, 2020

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE3140 BASEC2016-01992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data transcription and data entry will be under responsibility of SUPSI. Data ownership will remain with SUPSI who signed a contract of availability to the use for the purposes of research, dissemination of results and their publication. All visual and paper material will be stored at SUPSI in closets and filing cabinets fitted with keys. Information recorded on paper will be promptly transferred in a specifically designed password-protected electronic archive or database; access to the personal computer containing the electronic implementation will be protected by an access key. In the database, each subject will be associated to an participant code without identity record, which will be stored separately and protected by password known only to the research manager or her delegate. The code will constitute the key linkage between subjects' identity record and the information obtained during the Doll Therapy study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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