Vol. 4 No. 1 (2021): International Journal of Aging Research
Research Articles

Efficacy of Doll thErapy compared with standard treatment in the control of behavioral and psychologic Symptoms and CaRegIver Burden in dEmentia: DESCRIBE a randomized, controlled study

Massimiliano Massaia1, Maria Garro1, Valeria Quaranta1, Elisa Calvi1, Francesca Santagata1, Patrizia D’Amelio1,2*
1Department of Medical Science, Geriatric and Bone Diseases Unit, University of Torino, Torino, Italy. 2Department of Internal Medicine, Service of Geriatric Medicine and Geriatric Rehabilitation, University of Lausanne Hospital Centre, Lausanne, Switzerland.


  • dementia; behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach.

How to Cite

Massimiliano Massaia1, Maria Garro1, Valeria Quaranta1, Elisa Calvi1, Francesca Santagata1, Patrizia D’Amelio1,2*. (2021). Efficacy of Doll thErapy compared with standard treatment in the control of behavioral and psychologic Symptoms and CaRegIver Burden in dEmentia: DESCRIBE a randomized, controlled study. International Journal of Aging Research, 4(1), 79. https://doi.org/10.28933/ijoar-2021-02-1905


Behavioral and psychologic symptoms of dementia (BPSD) are frequent and represent a burden for patients and caregivers; in particular, the presence of agitation and aggression (A/A) has an important impact on patients’ quality of life. As psychotropic drugs can induce severe collateral effects, the use of a first line non-pharmacologic approach is highly recommended.
Here we evaluate the effect of doll therapy (DT) on A/A in geriatric patients with moderate to severe dementia hospitalized in an acute geriatric unit.
We enrolled fifty-two acute in-patients with dementia and A/A. Subjects were randomized to DT (26) or standard treatment (ST, 26), we measured agitation and caregiver burden with standard clinical scales at baseline and during treatment. In order to evaluate the effect of DT withdrawal, we carried out a telephonic follow-up interview after 1 and 4 weeks from hospital discharge.
DT is more effective than ST in the control of agitation, but not in reducing the professional caregiver burden. The use of pro re nata psychotropic drugs was reduced in patients treated with DT. After DT withdrawal, A/A progressively increased.
In conclusion we show that DT may be more effective than ST in the control of A/A in acute geriatric in-patients affected by dementia. Our results suggest that, in patients affected by severe to moderate forms of dementia with A/A, DT may be used as a first line treatment, not only in nursing home residents, but also in acute care geriatric in-patients.


  1. 2018 Alzheimer’s Disease Facts and Figures. Alzheimer’s & Dementia 2018, 14 (3), 367–429. https://doi.org/10.1016/j.jalz.2018.02.001.
  2. Prince, M. J. World Alzheimer Report 2015: The Global Impact of Dementia https://www.alz.co.uk/research/world-report-2015 (accessed Mar 5, 2020).
  3. Kales, H. C.; Gitlin, L. N.; Lyketsos, C. G. Assessment and Management of Behavioral and Psychological Symptoms of Dementia. BMJ 2015, 350, h369.https://doi.org/10.1136/bmj.h369.
  4. Lyketsos, C. G.; Carrillo, M. C.; Ryan, J. M.; Khachaturian, A. S.; Trzepacz, P.; Amatniek, J.; Cedarbaum, J.; Brashear, R.; Miller, D. S. Neuropsychiatric Symptoms in Alzheimer’s Disease. lzheimers Dement 2011, 7 (5), 532–539. https://doi.org/10.1016/j.jalz.2011.05.2410.
  5. Geda, Y. E.; Schneider, L. S.; Gitlin, L. N.; Miller, D. S.; Smith, G. S.; Bell, J.; Evans, J.; Lee, M.; Porsteinsson, A.; Lanctôt, K. L.; Rosenberg, P. B.; Sultzer, D. L.; Francis, P. T.; Brodaty, H.; Padala, P. P.; Onyike, C. U.; Ortiz, L. A.; Ancoli-Israel, S.; Bliwise, D. L.; Martin, J. L.; Vitiello, M. V.; Yaffe, K.; Zee, P. C.; Herrmann, N.; Sweet, R. A.; Ballard, C.; Khin, N. A.; Alfaro, C.; Murray, P. S.; Schultz, S.; Lyketsos, C. G.; Neuropsychiatric Syndromes Professional Interest Area of ISTAART. Neuropsychiatric Symptoms in Alzheimer’s Disease: Past Progress and Anticipation of the Future. Alzheimers Dement 2013, 9 (5), 602–608. https://doi.org/10.1016/j.jalz.2012.12.001.
  6. Ismail, Z.; Smith, E. E.; Geda, Y.; Sultzer, D.; Brodaty, H.; Smith, G.; Agüera-Ortiz, L.; Sweet, R.; Miller, D.; Lyketsos, C. G.; ISTAART Neuropsychiatric Symptoms Professional Interest Area. Neuropsychiatric Symptoms as Early Manifestations of Emergent Dementia: Provisional Diagnostic Criteria for Mild Behavioral Impairment. Alzheimers Dement 2016, 12 (2), 195–202. https://doi.org/10.1016/j.jalz.2015.05.017.
  7. Petrovic, M.; Hurt, C.; Collins, D.; Burns, A.; Camus, V.; Liperoti, R.; Marriott, A.; Nobili, F.; Robert, P.; Tsolaki, M.; Vellas, B.; Verhey, F.; Byrne, E. J. Clustering of Behavioural and Psychological Symptoms in Dementia (BPSD): A European Alzheimer’s Disease Consortium (EADC) Study. Acta Clin Belg 2007, 62 (6), 426–432. https://doi.org/10.1179/acb.2007.062.
  8. Savva, G. M.; Zaccai, J.; Matthews, F. E.; Davidson, J. E.; McKeith, I.; Brayne, C.; Medical Research Council Cognitive Function and Ageing Study. Prevalence, Correlates and Course of Behavioural and Psychological Symptoms of Dementia in the Population. Br J Psychiatry 2009, 194 (3), 212–219. https://doi.org/10.1192/bjp.bp.108.049619.
  9. Hendriks, S. A.; Smalbrugge, M.; Galindo-Garre, F.; Hertogh, C. M. P. M.; van der Steen, J. T. From Admission to Death: Prevalence and Course of Pain, Agitation, and Shortness of Breath, and Treatment of These Symptoms in Nursing Home Residents with Dementia. J Am Med Dir Assoc 2015, 16 (6), 475–481. https://doi.org/10.1016/j.jamda.2014.12.016.
  10. Ryu, S.-H.; Katona, C.; Rive, B.; Livingston, G. Persistence of and Changes in Neuropsychiatric Symptoms in Alzheimer Disease over 6 Months: The LASER-AD Study. Am J Geriatr Psychiatry 2005, 13 (11), 976–983. https://doi.org/10.1176/appi.ajgp.13.11.976.
  11. Chiao, C.-Y.; Wu, H.-S.; Hsiao, C.-Y. Caregiver Burden for Informal Caregivers of Patients with Dementia: A Systematic Review. Int Nurs Rev 2015, 62 (3), 340–350. https://doi.org/10.1111/inr.12194.
  12. Wetzels, R. B.; Zuidema, S. U.; de Jonghe, J. F. M.; Verhey, F. R. J.; Koopmans, R. T. C. M. Determinants of Quality of Life in Nursing Home Residents with Dementia. Dement Geriatr Cogn Disord 2010, 29 (3), 189–197. https://doi.org/10.1159/000280437.
  13. Okura, T.; Plassman, B. L.; Steffens, D. C.; Llewellyn, D. J.; Potter, G. G.; Langa, K. M. Neuropsychiatric Symptoms and the Risk of Institutionalization and Death: The Aging, Demographics, and Memory Study. J Am Geriatr Soc 2011, 59 (3), 473–481. https://doi.org/10.1111/j.1532-5415.2011.03314.x.
  14. De Mauleon, A.; Delrieu, J.; Cantet, C.; Vellas, B.; Andrieu, S.; Rosenberg, P. B.; Lyketsos, C. G.; Soto Martin, M. Longitudinal Course of Agitation and Aggression in Patients with Alzheimer’s Disease in a Cohort Study: Methods, Baseline and Longitudinal Results of the A3C Study. J Prev Alzheimers Dis 2021, 8 (2), 199–209. https://doi.org/10.14283/jpad.2020.66.
  15. Costa, N.; Wübker, A.; De Mauléon, A.; Zwakhal. en, S. M. G.; Challis, D.; Leino-Kilpi, H.; Hallberg, I. R.; Stephan, A.; Zabalegui, A.; Saks, K.; Molinier, L.; Wimo, A.; Vellas, B.; Sauerland, D.; Binot, I.; Soto, M. E.; RightTimePlaceCare consortium. Costs of Care of Agitation Associated With Dementia in 8 European Countries: Results From the RightTimePlaceCare Study. J Am Med Dir Assoc 2018, 19 (1), 95.e1-95.e10. https://doi.org/10.1016/j.jamda.2017.10.013.
  16. Howard, R.; McShane, R.; Lindesay, J.; Ritchie, C.; Baldwin, A.; Barber, R.; Burns, A.; Dening, T.; Findlay, D.; Holmes, C.; Hughes, A.; Jacoby, R.; Jones, R.; Jones, R.; McKeith, I.; Macharouthu, A.; O’Brien, J.; Passmore, P.; Sheehan, B.; Juszczak, E.; Katona, C.; Hills, R.; Knapp, M.; Ballard, C.; Brown, R.; Banerjee, S.; Onions, C.; Griffin, M.; Adams, J.; Gray, R.; Johnson, T.; Bentham, P.; Phillips, P. Donepezil and Memantine for Moderate-to-Severe Alzheimer’s Disease. N. Engl. J. Med. 2012, 366 (10), 893–903. https://doi.org/10.1056/NEJMoa1106668.
  17. Tampi, R. R.; Tampi, D. J.; Balachandran, S.; Srinivasan, S. Antipsychotic Use in Dementia: A Systematic Review of Benefits and Risks from Meta-Analyses. Ther Adv Chronic Dis 2016, 7 (5), 229–245. https://doi.org/10.1177/2040622316658463.
  18. Maher, A. R.; Maglione, M.; Bagley, S.; Suttorp, M.; Hu, J.-H.; Ewing, B.; Wang, Z.; Timmer, M.; Sultzer, D.; Shekelle, P. G. Efficacy and Comp arative Effectiveness of Atypical Antipsychotic Medications for Off-Label Uses in Adults: A Systematic Review and Meta-Analysis. JAMA 2011, 306 (12), 1359–1369. https://doi.org/10.1001/jama.2011.1360.
  19. Bierman, E. J. M.; Comijs, H. C.; Gundy, C. M.; Sonnenberg, C.; Jonker, C.; Beekman, A. T. F. The Effect of Chronic Benzodiazepine Use on Cognitive Functioning in Older Persons: Good, Bad or Indifferent? Int J Geriatr Psychiatry 2007,. 22 (12), 1194–1200. https://doi.org/10.1002/gps.1811.
  20. Seitz, D. P.; Brisbin, S.; Herrmann, N.; Rapoport, M. J.; Wilson, K.; Gill, S. S.; Rines, J.; Le Clair, K.; Conn, D. Efficacy and Feasibility of Nonpharmacological Interventions for Neuropsychiatric Symptoms of Dementia in Long Term Care: A Systematic Review. J Am Med Dir Assoc 2012, 13 (6), 503-506.e2. https://doi.org/10.1016/j.jamda.2011.12.059.
  21. Abraha, I.; Rimland, J. M.; Trotta, F. M.; Dell’Aquila, G.; Cruz-Jentoft, A.; Petrovic, M.; Gudmundsson, A.; Soiza, R.; O’Mahony, D.; Guaita, A.; Cherubini, A. Systematic Review of Systematic Reviews of Non-Pharmacological Interventions to Treat Behavioural Disturbances in Older Patients with Dementia. The SENATOR-OnTop Series. BMJ Open 2017, 7 (3). https://doi.org/10.1136/bmjopen-2016-012759.
  22. Lyketsos, C. G.; Colenda, C. C.; Beck, C.; Blank, K.; Doraiswamy, M. P.; Kalunian, D. A.; Yaffe, K.; Task Force of American Association for Geriatric Psychiatry. Position Statement of the American Association for Geriatric Psychiatry Regarding Principles of Care for Patients with Dementia Resulting from Alzheimer Disease. Am J Geriatr Psychiatry 2006, 14 (7), 561–572. https://doi.org/10.1097/01.JGP.0000221334.65330.55.
  23. Finnema, E.; Dröes, R. M.; Ribbe, M.; Van Tilburg, W. The Effects of Emotion-Oriented Approaches in the Care for Persons Suffering from Dementia: A Review of the Literature. Int J Geriatr Psychiatry 2000, 15 (2), 141–161. https://doi.org/10.1002/(sici)1099- 1166(200002)15:2<141::aid-gps92>3.0.co;2-5.
  24. Mileski, M.; Baar Topinka, J.; Brooks, M.; Lonidier, C.; Linker, K.; Vander Veen, K. Sensory and Memory Stimulation as a Means to Care for Individuals with Dementia in Long-Term Care Facilities. Clin Interv Aging 2018, 13, 967–974. https://doi.org/10.2147/CIA.S153113.
  25. Ng, Q. X.; Ho, C. Y. X.; Koh, S. S. H.; Tan, W. C.; Chan, H. W. Doll Therapy for Dementia Sufferers: A Systematic Review. Complementary Therapies in Clinical Practice 2017, 26, 42–46. https://doi.org/10.1016/j.ctcp.2016.11.007.
  26. Pezzati, R.; Molteni, V.; Bani, M.; Settanta, C.; Di Maggio, M. G.; Villa, I.; Poletti, B.; Ardito, R. B. 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, 5. https://doi.org/10.3389/fpsyg.2014.00342.
  27. Bisiani, L.; Angus, J. Doll Therapy: A Therapeutic Means to Meet Past Attachment Needs and Diminish Behaviours of Concern in a Person Living with Dementia–a Case Study Approach. Dementia (London) 2013, 12 (4), 447–462. https://doi.org/10.1177/1471301211431362.
  28. Browne, C. J.; Shlosberg, E. Attachment Theory, Ageing and Dementia: A Review of the Literature. Aging Ment Health 2006, 10 (2), 134–142. https://doi.org/10.1080/13607860500312118.
  29. Miesen, B. M. L. Alzheimer’s Disease, the Phenomenon of Parent Fixation and Bowlby’s Attachment Theory. International Journal of Geriatric Psychiatry 1993, 8 (2), 147–153. https://doi.org/10.1002/gps.930080207.
  30. Stephens, A.; Cheston, R.; Gleeson, K. An Exploration into the Relationships People with Dementia Have with Physical Objects: An Ethnographic Study: Dementia 2012. https://doi.org/10.1177/1471301212442585.
  31. Mitchell, G.; McCormack, B.; McCance, T. Therapeutic Use of Dolls for People Living with. Dementia: A Critical Review of the Literature: Dementia 2014. https://doi.org/10.1177/1471301214548522.
  32. James, I. A.; Mackenzie, L.; Mukaetova-Ladinska, E. Doll Use in Care Homes for People with Dementia. Int J Geriatr Psychiatry 2006, 21 (11), 1093–1098. https://doi.org/10.1002/gps.1612.
  33. Shin, J. H. Doll Therapy: An Intervention for Nursing Home Residents with Dementia. J Psychosoc Nurs Ment Health Serv 2015, 53 (1), 13–18. https://doi.org/10.3928/02793695- 20141218-03.
  34. Green, L.; Matos, P.; Murillo, I.; Neushotz, L.; Popeo, D.; Aloysi, A.; Samuel, J.; Craig, E.; Porter, C.; Fitzpatrick, J. J. 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, 25 (5), 388–389. https://doi.org/10.1016/j.apnu.2011.05.003.
  35. Braden, B. A.; Gaspar, P. M. Implementation of a Baby Doll Therapy Protocol for People with Dementia: Innovative Practice. Dementia (London) 2015, 14 (5), 696–706. https://doi.org/10.1177/1471301214561532.
  36. Boutron, I.; Moher, D.; Altman, D. G.; Schulz, K. F.; Ravaud, P.; CONSORT Group. Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann. Intern. Med. 2008, 148 (4), 295–309. https://doi.org/10.7326/0003-4819-148-4-200802190-00008.
  37. Kim, J.; Shin, W. How to Do Random Allocation (Randomization). Clin Orthop Surg 2014, 6 (1), 103–109. https://doi.org/10.4055/cios.2014.6.1.103.
  38. Cohen-Mansfield, J.; Marx, M. S.; Dakheel-Ali, M.; Regier, N. G.; Thein, K. Can Persons with Dementia Be Engaged with Stimuli? Am J Geriatr Psychiatry 2010, 18 (4), 351–362. https://doi.org/10.1097/jgp.0b013e3181c531fd.
  39. Wing, L.; Leekam, S. R.; Libby, S. J.; Gould, J.; Larcombe, M. The Diagnostic Interview for Social and Communication Disorders: Background, Inter-Rater Reliability and Clinical Use. J Child Psychol Psychiatry 2002, 43 (3), 307–325. https://doi.org/10.1111/1469-7610.00023.
  40. Fenzio, F. Manuale di consulenza pedagogica in ambito familiare, giuridico e scolastico; Youcanprint, 2017. Olin, K. Perceived Caregiver Burden as a Function of Differential Coping Strategies: (410202005-016), 1995. https://doi.org/10.1037/e410202005-016.
  41. Marvardi, M.; Mattioli, P.; Spazzafumo, L.; Mastriforti, R.; Rinaldi, P.; Polidori, M. C.; Cherubini, A.; Quartesan, R.; Bartorelli, L.; Bonaiuto, S.; Cucinotta, D.; Di Iorio, A.; Gallucci, M.; Giordano, M.; Martorelli, M.; Masaraki, G.; Nieddu, A.; Pettenati, C.; Putzu, P.; Solfrizzi, V.; Tammaro, A. E.; Tomassini, P. F.; Vergani, C.; Senin, U.; Mecocci, P.; Study Group on Brain Aging; Italian Society of Gerontology and Geriatrics. The Caregiver Burden Inventory in Evaluating the Burden of Caregivers of Elderly Demented Patients: Results from a Multicenter Study. Aging Clin Exp Res 2005, 17 (1), 46–53. https://doi.org/10.1007/bf03337720.
  42. 51(43) Bellelli, G.; Morandi, A.; Davis, D. H. J.; Mazzola, P.; Turco, R.; Gentile, S.; Ryan, T.; Cash, H.; Guerini, F.; Torpilliesi, T.; Del Santo, F.; Trabucchi, M.; Annoni, G.; MacLullich, A. M. J. Validation of the 4AT, a New Instrument for Rapid Delirium Screening: A Study in 234 Hospitalised Older People. Age Ageing 2014, 43 (4), 496–502. https://doi.org/10.1093/ageing/afu021.
  43. Pfeiffer, E. A Short Portable Mental Status Questionnaire for the Assessment of Organic Brain Deficit in Elderly Patients†. Journal of the American Geriatrics Society 1975, 23 (10), 433–441. https://doi.org/10.1111/j.1532-5415.1975.tb00927.x.
  44. Katz, S.; Downs, T. D.; Cash, H. R.; Grotz, R. C. Progress in Development of the Index of ADL. Gerontologist 1970, 10 (1), 20–30. https://doi.org/10.1093/geront/10.1_part_1.20.
  45. Faul, F.; Erdfelder, E.; Lang, A.-G.; Buchner, A. G*Power 3: A Flexible Statistical Power Analysis Program for the Social, Behavioral, and Biomedical Sciences. Behavior Research Methods 2007, 39 (2), 175–191. https://doi.org/10.3758/BF03193146.
  46. Balzotti, A.; Filograsso, M.; Altamura, C.; Fairfield, B.; Bellomo, A.; Daddato, F.; Vacca, R. A.; Altamura, M. Comparison of the Efficacy of Gesture-Verbal Treatment and Doll Therapy for Managing Neuropsychiatric Symptoms in Older Patients with Dementia. International Journal of Geriatric Psychiatry 2019, 34 (9), 1308–1315. https://doi.org/10.1002/gps.4961.
  47. Cantarella, A.; Borella, E.; Faggian, S.; Navuzzi, A.; De Beni, R. Using Dolls for Therapeutic 18 Purposes: A Study on Nursing Home Residents with Severe Dementia. Int J Geriatr Psychiatry 2018, 33 (7), 915–925.
  48. a. https://doi.org/10.1002/gps.4872.
  49. Moyle, W.; Murfield, J.; Jones, C.; Beattie, E.; Draper, B.; Ownsworth, T. Can Lifelike Baby Dolls Reduce Symptoms of Anxiety, Agitation, or Aggression for People with Dementia in Long-Term Care? Findings from a Pilot Randomised Controlled Trial. Aging Ment Health 2019, 23 (10), 1442–1450. https://doi.org/10.1080/13607863.2018.1498447.
  50. Yilmaz, C. K.; A?iret, G. D. The Effect of Doll Therapy on Agitation and Cognitive State in Institutionalized Patients With Moderate-to-Severe Dementia: A Randomized Controlled Study. J Geriatr Psychiatry Neurol 2020, 891988720933353. https://doi.org/10.1177/0891988720933353.
  51. Feng, Z.; Coots, L. A.; Kaganova, Y.; Wiener, J. M. Hospital and ED Use among Medicare Beneficiaries with Dementia Varies by Setting and Proximity to Death. Health Aff (Millwood) 2014, 33 (4), 683–690. https://doi.org/10.1377/hlthaff.2013.1179.
  52. Phelan, E. A.; Borson, S.; Grothaus, L.; Balch, S.; Larson, E. B. Association of Incident Dementia with Hospitalizations. JAMA 2012, 307 (2), 165–172. https://doi.org/10.1001/jama.2011.1964.
  53. White, N.; Leurent, B.; Lord, K.; Scott, S.; Jones, L.; Sampson, E. L. The Management of Behavioural and Psychological Symptoms of Dementia in the Acute General Medical Hospital: A Longitudinal Cohort Study. Int J Geriatr Psychiatry 2017, 32 (3), 297–305. https://doi.org/10.1002/gps.4463.
  54. Hessler, J. B.; Schäufele, M.; Hendlmeier, I.; Junge, M. N.; Leonhardt, S.; Weber, J.; Bickel, H. Behavioural and Psychological Symptoms in General Hospital Patients with Dementia, Distress for Nursing Staff and Complications in Care: Results of the General Hospital Study. Epidemiol Psychiatr Sci 2018, 27 (3), 278–287. https://doi.org/10.1017/S2045796016001098.
  55. Jurgens, F. J.; Clissett, P.; Gladman, J. R. F.; Harwood, R. H. Why Are Family Carers of People with Dementia Dissatisfied with General Hospital Care? A Qualitative Study. BMC Geriatr 2012, 12, 57. https://doi.org/10.1186/1471-2318-12-57.
  56. Kennedy, M.; Koehl, J.; Shenvi, C. L.; Greenberg, A.; Zurek, O.; LaMantia, M.; Lo, A. X. The Agitated Older Adult in the Emergency Department: A Narrative Review of Common Causes and Management Strategies. J Am Coll Emerg Physicians Open 2020, 1 (5), 812–823. https://doi.org/10.1002/emp2.12110.
  57. Salari, S. M. Intergenerational Partnerships in Adult Day Centers: Importance of Age- Appropriate Environments and Behaviors. Gerontologist 2002, 42 (3), 321–333. https://doi.org/10.1093/geront/42.3.321.