DementiaADTSNCT03224143
Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial
A study testing Doll Therapy Intervention in people with Dementia, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dementia
- What is being tested?
- Doll Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Feb 2017to 16 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Dementia
- Being tested
- Doll Therapy Intervention, active control group (SI)
- Keywords
- dementia, doll therapy, attachment
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doll Therapy InterventionBehavioural
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 control group (SI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: active control group (SI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: after 30 days since the beginning of intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start16 Feb 2017
- Primary completion16 Feb 2020 (estimated)
- Study completion16 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Golgi Cenci, University of Turin, Italy, Gruppo Doll Therapy Ticino, Case per Anziani Canton Ticino, Centro di Terapia Cognitiva, Como
- Responsible party
- Sponsor
- Investigators
- Rita Pezzati, Principal investigator, University of Applied Sciences and Arts of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224143
- Sponsor's protocol ID
- CE3140 BASEC2016-01992
- Acronym
- ADTS
- Status last verified
- Jul 2017
- First submitted
- 15 Mar 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ainsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Hills-dale. NJ Eribaum.
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.
PubMed 11708737Browne 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.
PubMed 16517488Ellingford, L., Mackenzie, L., & Marsland, L. (2007). Using dolls to alter behavior in people with dementia. Nursing Times, (103), 36-37.
George, C., Kaplan, N., & Main, M. (1985). Adult Attachment Interview. (U. of C. Department of Psychology, Ed.)Unpublished manuscript. Berkeley.
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.
PubMed 16955418Miesen, B., & Jones, G. (2010). Care-giving in dementia: Contours of a curriculum. Dementia, 9(4), 473-489. http://doi.org/10.1177/1471301210381680
Lupien SJ, Lepage M. Stress, memory, and the hippocampus: can't live with it, can't live without it. Behav Brain Res. 2001 Dec 14;127(1-2):137-58. doi: 10.1016/s0166-4328(01)00361-8.
PubMed 11718889Mitchell G, McCormack B, McCance T. Therapeutic use of dolls for people living with dementia: A critical review of the literature. Dementia (London). 2016 Sep;15(5):976-1001. doi: 10.1177/1471301214548522. Epub 2014 Aug 25.
PubMed 25160532Pezzati 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.
PubMed 24795682van 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.
PubMed 7777645Vreeburg 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.
PubMed 20190128Tamura, 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.
Tsigos C, Chrousos GP. Hypothalamic-pituitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002 Oct;53(4):865-71. doi: 10.1016/s0022-3999(02)00429-4.
PubMed 12377295Quirin 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.
PubMed 20007241
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03224143
- Acronym / sponsor ID
- ADTS / CE3140 BASEC2016-01992
- Conditions
- Dementia
- Keywords
- dementia, doll therapy, attachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Applied Sciences and Arts of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- Fondazione Golgi Cenci, University of Turin, Italy, Gruppo Doll Therapy Ticino, Case per Anziani Canton Ticino, Centro di Terapia Cognitiva, Como
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 16 Feb 2020 (estimated)
- Study completion
- 16 Feb 2020 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Doll Therapy Intervention (DTI) | Experimental | Behavioral: Doll Therapy InterventionThe 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. |
| Active control group (SI) | Active comparator | Behavioral: 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- • presence of moderate to severe dementia, assessed with Global Deterioration Scale (GDS 4-7);
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doll Therapy InterventionDaily 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. | Behavioural | Doll Therapy Intervention (DTI) |
| 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. | Behavioural | Active control group (SI) |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- BackgroundAinsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Hills-dale. NJ Eribaum.
- Background: PubMed 11708737Bradley 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.
- Background: PubMed 16517488Browne 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.
- BackgroundEllingford, L., Mackenzie, L., & Marsland, L. (2007). Using dolls to alter behavior in people with dementia. Nursing Times, (103), 36-37.
- BackgroundGeorge, C., Kaplan, N., & Main, M. (1985). Adult Attachment Interview. (U. of C. Department of Psychology, Ed.)Unpublished manuscript. Berkeley.
- Background: PubMed 16955418James 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.
- BackgroundMiesen, B., & Jones, G. (2010). Care-giving in dementia: Contours of a curriculum. Dementia, 9(4), 473-489. http://doi.org/10.1177/1471301210381680
- Background: PubMed 11718889Lupien SJ, Lepage M. Stress, memory, and the hippocampus: can't live with it, can't live without it. Behav Brain Res. 2001 Dec 14;127(1-2):137-58. doi: 10.1016/s0166-4328(01)00361-8.
- Background: PubMed 25160532Mitchell G, McCormack B, McCance T. Therapeutic use of dolls for people living with dementia: A critical review of the literature. Dementia (London). 2016 Sep;15(5):976-1001. doi: 10.1177/1471301214548522. Epub 2014 Aug 25.
- Background: PubMed 24795682Pezzati 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.
- Background: PubMed 7777645van 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.
- Background: PubMed 20190128Vreeburg 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Pezzati principal investigator
University of Applied Sciences and Arts of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doll Therapy Intervention in people with Dementia, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral and psychiatric symptoms (time frame: from baseline (T0) to 30 days since the beginning of intervention (T1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224143, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.