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

NCT03224143 | Unknown DMC

• 1 other identifier: CE3140 BASEC2016-01992
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia

Keywords

dementia; doll therapy; attachment

Outcome Measures

Primary Outcomes (6)

• Behavioral and psychiatric symptoms

  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

  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

  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

  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

  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

  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 Outcomes (1)

• association between the pre-morbid attachment style of PWD and the response to DTI

  after 30 days since the beginning of intervention (T1)

Study Arms (2)

Doll Therapy Intervention (DTI)

EXPERIMENTAL

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

Active control group (SI)

ACTIVE COMPARATOR

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)

Interventions

Doll Therapy Intervention BEHAVIORAL

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.

Doll Therapy Intervention (DTI)

active control group (SI) BEHAVIORAL

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.

Active control group (SI)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Applied Sciences and Arts of Southern Switzerland: lead
• Fondazione Golgi Cenci: collaborator
• University of Turin, Italy: collaborator
• Gruppo Doll Therapy Ticino: collaborator
• Case per Anziani Canton Ticino: collaborator
• Centro di Terapia Cognitiva, Como: collaborator

Study Sites (1)

SUPSI

Manno, 6928, Switzerland

Location

Related Publications (20)

• Ainsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Hills-dale. NJ Eribaum.

  BACKGROUND

• Bradley JM, Cafferty TP. Attachment among older adults: current issues and directions for future research. Attach Hum Dev. 2001 Sep;3(2):200-21. doi: 10.1080/14616730126485.

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• Browne CJ, Shlosberg E. Attachment theory, ageing and dementia: a review of the literature. Aging Ment Health. 2006 Mar;10(2):134-42. doi: 10.1080/13607860500312118.

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• Ellingford, L., Mackenzie, L., & Marsland, L. (2007). Using dolls to alter behavior in people with dementia. Nursing Times, (103), 36-37.

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• George, C., Kaplan, N., & Main, M. (1985). Adult Attachment Interview. (U. of C. Department of Psychology, Ed.)Unpublished manuscript. Berkeley.

  BACKGROUND

• James IA, Mackenzie L, Mukaetova-Ladinska E. Doll use in care homes for people with dementia. Int J Geriatr Psychiatry. 2006 Nov;21(11):1093-8. doi: 10.1002/gps.1612.

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• Miesen, B., & Jones, G. (2010). Care-giving in dementia: Contours of a curriculum. Dementia, 9(4), 473-489. http://doi.org/10.1177/1471301210381680

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• Pezzati R, Molteni V, Bani M, Settanta C, Di Maggio MG, Villa I, Poletti B, Ardito RB. Can Doll therapy preserve or promote attachment in people with cognitive, behavioral, and emotional problems? A pilot study in institutionalized patients with dementia. Front Psychol. 2014 Apr 21;5:342. doi: 10.3389/fpsyg.2014.00342. eCollection 2014.

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• van IJzendoorn MH. Adult attachment representations, parental responsiveness, and infant attachment: a meta-analysis on the predictive validity of the Adult Attachment Interview. Psychol Bull. 1995 May;117(3):387-403. doi: 10.1037/0033-2909.117.3.387.

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• Vreeburg SA, Zitman FG, van Pelt J, Derijk RH, Verhagen JC, van Dyck R, Hoogendijk WJ, Smit JH, Penninx BW. Salivary cortisol levels in persons with and without different anxiety disorders. Psychosom Med. 2010 May;72(4):340-7. doi: 10.1097/PSY.0b013e3181d2f0c8. Epub 2010 Feb 26.

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• Tamura, T., Nakajima, K., Nambu, M., Nakamura, K., Yonemitsu, S., Itoh, A., … Uno, H. (2001). Baby dolls as therapeutic tools for severe dementia patients. Gerontechnology, 1(2), 111-118.

  BACKGROUND

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  PMID: 12377295 BACKGROUND

• Quirin M, Gillath O, Pruessner JC, Eggert LD. Adult attachment insecurity and hippocampal cell density. Soc Cogn Affect Neurosci. 2010 Mar;5(1):39-47. doi: 10.1093/scan/nsp042. Epub 2009 Dec 9.

  PMID: 20007241 BACKGROUND

• Lai CK. The merits and problems of Neuropsychiatric Inventory as an assessment tool in people with dementia and other neurological disorders. Clin Interv Aging. 2014 Jul 8;9:1051-61. doi: 10.2147/CIA.S63504. eCollection 2014.

  PMID: 25031530 BACKGROUND

• Green L, Matos P, Murillo I, Neushotz L, Popeo D, Aloysi A, Samuel J, Craig E, Porter C, Fitzpatrick JJ. Use of dolls as a therapeutic intervention: relationship to previous negative behaviors and pro re nata (prn) Haldol use among geropsychiatric inpatients. Arch Psychiatr Nurs. 2011 Oct;25(5):388-9. doi: 10.1016/j.apnu.2011.05.003. Epub 2011 Jul 12.

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• Baranzini F, Grecchi A, Berto E, Costantini C, Ceccon F, Cazzamalli S, Callegari C. [Factor analysis and psychometric properties of the Italian version of the Neuropsychiatric Inventory-Nursing Home in an institutionalized elderly population with psychiatric comorbidity]. Riv Psichiatr. 2013 Jul-Aug;48(4):335-44. doi: 10.1708/1319.14631. Italian.

  PMID: 24056833 BACKGROUND

• Vaccaro R, Ballabio R, Molteni V, Ceppi L, Ferrari B, Cantu M, Zaccaria D, Vandoni C, Ardito RB, Adenzato M, Poletti B, Guaita A, Pezzati R. Doll therapy intervention for women with dementia living in nursing homes: a randomized single-blind controlled trial protocol. Trials. 2020 Feb 3;21(1):133. doi: 10.1186/s13063-020-4050-8.

  PMID: 32014029 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rita Pezzati

  University of Applied Sciences and Arts of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure blinding, the psychologist who will administer the NPI-NH will not be aware of the arm to which the subjects belong.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: July 21, 2017
• Study Start: February 16, 2017
• Primary Completion: February 16, 2020
• Study Completion: February 16, 2020
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)