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Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658394
Recruitment Status : Completed
First Posted : December 8, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Rsocialform - Geriatria, Lda

Brief Summary:
This research aims to evaluate the ability of individual reminiscence therapy (RT), using a simple reminiscence format, to improve the overall cognitive function, memory, emotional status and quality of life (QoL) of older adults with neurocognitive disorders (NCD) attending social care and support services. A multicentre randomised controlled trial (RCT) is proposed in Azores archipelago with repeated measures (pre-intervention, post-intervention and follow-up). Intervention group will hold 26 individual RT sessions, twice a week for 13 weeks. Control group participants will maintain their treatment as usual. Make a subsample analysis of the main clinical diagnoses, and compare the results of sample and subsample with a previous study that had the same intervention protocol.

Condition or disease Intervention/treatment Phase
Dementia Neurocognitive Disorders Cognitive Impairment Cognitive Dysfunction Cognitive Decline Other: Reminiscence therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Individual Reminiscence Therapy in the Elderly People With Neurocognitive Disorders: A Multicentre Randomised Controlled Trial in Azores Archipelago
Actual Study Start Date : February 11, 2021
Actual Primary Completion Date : August 31, 2021
Actual Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Intervention Group
Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving RT or to a control group receiving treatment as usual. Participants in the intervention group will participate in two RT sessions per week for 13 weeks besides their treatment as usual. The sessions will be based on the Book of the Past and the Present and they will follow the same protocol in every participant institution.
Other: Reminiscence therapy
Intervention group will receive two RT sessions per week for 13 weeks. RT sessions will last approximately 50 minutes and will be developed according to the following structure: · Welcome to the patient and reality orientation therapy (7 minutes) · Conducting the main activity of reminiscence (40 minutes) · Closure, thank you for the participation and farewell until the next session (3 minutes) Reminiscence therapy sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of RT. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of the Past and the Present.

No Intervention: Control Group
Participants assigned to the control group will maintain their usual treatment in the institution, participating in the activities previously assigned to their individual care plan.



Primary Outcome Measures :
  1. Cognitive functioning evaluated through Mini-Mental State Examination [MMSE] [ Time Frame: baseline ]
    Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

  2. Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE] [ Time Frame: 13 weeks after the beginning of the intervention ]
    Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

  3. Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE] [ Time Frame: 12 weeks after end of intervention ]
    Cognitive functioning is assessed using the MMSE which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.


Secondary Outcome Measures :
  1. Quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD] [ Time Frame: baseline ]
    The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.

  2. Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD] [ Time Frame: 13 weeks after the beginning of the intervention ]
    The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.

  3. Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD] [ Time Frame: 12 weeks after end of intervention ]
    The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life. It has good psychometric characteristics and its use has been recommended to evaluate psychosocial interventions.

  4. Anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI] [ Time Frame: baseline ]
    It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.

  5. Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI] [ Time Frame: 13 weeks after the beginning of the intervention ]
    It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.

  6. Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI] [ Time Frame: 12 weeks after end of intervention ]
    It assesses, in several contexts, the severity of anxiety symptoms in the older adults. It consists in 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.

  7. Mood assessed through the Geriatric Depression Scale-15 [GDS-15] [ Time Frame: baseline ]
    The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.

  8. Change in mood assessed through the Geriatric Depression Scale-15 [GDS-15] [ Time Frame: 13 weeks after the beginning of the intervention ]
    The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.

  9. Change in mood assessed through the Geriatric Depression Scale-15 [GDS-15] [ Time Frame: 12 weeks after end of intervention ]
    The GDS-15 is used to measure mood. It is considered a reliable tool to screen depressive symptoms in older people. With a dichotomous format (yes/no answers), this scale assesses depression in older people. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.

  10. Executive functions evaluated throught Frontal Assessment Battery [FAB] [ Time Frame: baseline ]
    The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.

  11. Change in executive functions evaluated throught Frontal Assessment Battery [FAB] [ Time Frame: 13 weeks after the beginning of the intervention ]
    The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.

  12. Change in executive functions evaluated throught Frontal Assessment Battery [FAB] [ Time Frame: 12 weeks after end of intervention ]
    The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.

  13. Memory function evaluated through Memory Alteration Test [MAT] [ Time Frame: baseline ]
    The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.

  14. Change in memory function evaluated through Memory Alteration Test [MAT] [ Time Frame: 13 weeks after the beginning of the intervention ]
    The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.

  15. Change in memory function evaluated through Memory Alteration Test [MAT] [ Time Frame: 12 weeks after end of intervention ]
    The MAT is used to assess memory function. It is an easy and quick instrument that assesses five memory domains: temporal orientation, encoding, semantic memory, free recall, and cued recall. Total scores range from 0 to 50, with higher scores indicating better memory. It has good psychometric properties and is highly sensitive to mild cognitive decline.


Other Outcome Measures:
  1. Sociodemographic information gathered through the sociodemographic questionnaire [ Time Frame: baseline ]
    Participants' answers in the sociodemographic questionnaire designed specifically for this study. It gathers information about gender, age, marital status, formal education, which social response the participant attends, medical comorbidities and cognitive symptoms and will be administered to all participants.

  2. Functional dependence evaluated through Barthel Index [IB] [ Time Frame: before baseline (exclusion criteria) ]
    This is a 10-item self-administered scale that evaluates the functional capacity to conduct daily life activities. The activities are quoted differently, 0, 1, 2 or 3 points can be assigned. The total score ranges from 0 (totally dependent) to 20 (totally independent), with a total of 0-8 being total dependency; 9-12 being serious dependency; 13-19 being moderate dependency; 20 being total independence. This instrument has item-total correlations between .66 and .93, and has a high internal consistency (Cronbach alpha of .96).



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having a formal diagnosis of a neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM-5] criteria (participants diagnosis will be confirm in their health records at the institution).
  • Having delivered the informed consent form, duly completed and signed, after prior information.
  • Being able to communicate and understand.
  • Possibility of gathering information about the participant's life history through family members or usual caregivers, using the socio-family questionnaire designed for that purpose.
  • Being 65 years of age or older.
  • Being a native Portuguese speaker.
  • Regularly attending an institution that provides social care and support services for older adults (including people living in long-term care centres, people attending day and social centres and people receiving home support services).

Exclusion Criteria:

  • Suffering from an acute or severe illness that prevent participation in the intervention sessions.
  • Severe sensory and physical limitations that prevent participation.
  • Low level of consciousness and minimal attention span.
  • Presence of severe neuropsychiatric symptoms, such as agitation, psychosis, severe depressive and anxiety symptoms, apathy, or presence of uncontrolled delirium that prevent participation in the sessions.
  • Traumatic life history or marked by adverse events that discourage participation in RT sessions; history of adverse reactions during RT sessions or similar activities.
  • Have a serious or total functional dependence (assessed through the Barthel index).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658394


Locations
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Portugal
Rsocialform - Geriatria, Lda.
Mealhada, Aveiro, Portugal, 3050-387
Santa Casa da Misericórdia da Horta
Horta, Faial, Portugal, 9900-033
Santa Casa da Misericórdia de Santa Cruz das Flores
Santa Cruz das Flores, Flores, Portugal
Santa Casa da Misericórdia de Lajes do Pico
Lajes, Pico, Portugal, 9930-126
Santa Casa da Misericórdia da Madalena do Pico
Madalena, Pico, Portugal, 9950-322
Santa Casa da Misericórdia de Vila do Porto
Vila do Porto, Santa Maria, Portugal, 9580-528
Santa Casa da Misericórdia da Calheta
Calheta, São Jorge, Portugal, 9850-070
Casa de Repouso João Inácio de Sousa
Velas, São Jorge, Portugal, 9800-559
Casa do Povo de Arrifes
Arrifes, São Miguel, Portugal, 9500-377
Casa do Povo da Maia
Maia, São Miguel, Portugal, 9625-320
Lar Luis Soares de Sousa de Ponta Delgada
Ponta Delgada, São Miguel, Portugal
Santa Casa da Misericórdia de Angra do Heroísmo
Angra Do Heroísmo, Terceira, Portugal, 9700-020
Lar D. Pedro V
Praia Da Vitória, Terceira, Portugal, 9760-438
Sponsors and Collaborators
Rsocialform - Geriatria, Lda
Investigators
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Principal Investigator: Susana I Justo Henriques, PhD Nursing School of Coimbra
Principal Investigator: Enrique Pérez Sáez, PhD National Reference Centre for Alzheimer's and Dementia Care, Imserso, Spain
Principal Investigator: João L. Alves Apóstolo, PhD Nursing School of Coimbra
Publications:
Apóstolo JLA, Bobrowicz-Campos EM, dos Reis IAC, Henriques SJ, Correia CAV. Exploring the screening capacity of the European Portuguese version of the 15-item Geriatric Depression Scale. Revista de Psicopatología y Psicología Clínica. 2018; 23: 99-107. doi: 10.5944/rppc.vol.23.num.2.2018.21050
Apóstolo J, Loureiro L, Reis I, Silva I, Cardoso D, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referência. 2014; IV(3): 65-73. doi: 10.12707/RIV14033
Araújo F, Pais-Ribeiro J, Oliveira A, Pinto C. Validação do índice de Barthel numa amostra de idosos não institucionalizados. Revista Portuguesa de Saúde Pública. 2007; 25(2): 59-66.
Guerreiro M, Silva AP, Botelho MA, Leitão O, Castro-Caldas A, Garcia C. Adaptação à população portuguesa da tradução do Mini Mental State Examination (MMSE). Revista Portuguesa de Neurologia. 1994; 1: 9-10.
Henriques SIJ. Livro do Passado e do Presente [Book of the Past and the Present]. Mealhada, Replicar Socialform; 2018.
Justo-Henriques SI, Pérez-Sáez E, Apóstolo JLA. Individual intervention protocol based on reminiscence therapy for older people with neurocognitive disorders. Revista de Enfermagem de Referência. 2020; 5(3): e20043. doi: 10.12707/RV20043
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Quality of life in Alzheimer's disease: Patient and caregiver reports. Journal of Mental Health and Aging. 1999; 5: 21-32.
Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental State Examination. Sinapse. 2009; 2: 10-16.
Prince M, Guerchet M, Prina M. World Alzheimer Report 2015. The global impact of dementia: An analysis of prevalence, incidence, cost and trends. London: Alzheimer´s Disease International (ADI); 2015. http://www.worldalzreport2015.org/downloads/world-alzheimer-report-2015.pdf
Subramaniam P, Woods B. Towards the therapeutic use of information and communication technology in reminiscence work for people with dementia: a systematic review. International Journal of Computers in Healthcare. 2010; 1: 106-125. doi: 10.1504/IJCIH.2010.037457.
Tadaka E, Kanagawa K. Effects of reminiscence group in elderly people with Alzheimer disease and vascular dementia in a community setting. Geriatrics & Gerontology International. 2007; 7: 167-173. doi: 10.1111/j.1447-0594.2007.00381.x
Thorgrimsen L, Schweitzer P, Orrell M. Evaluating reminiscence for people with dementia: A pilot study. The Arts in Psychotherapy. 2002; 29: 93-97. doi: 10.1016/S0197-4556(01)00135-6
Westerhof GJ, Bohlmeijer E, Webster JD. Reminiscence and mental health: A review of recent progress in theory, research and interventions. Ageing & Society. 2010; 30: 697-721. doi: 10.1017/S0144686X09990328

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Responsible Party: Rsocialform - Geriatria, Lda
ClinicalTrials.gov Identifier: NCT04658394    
Other Study ID Numbers: 21112020
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rsocialform - Geriatria, Lda:
dementia
reminiscence therapy
individual therapy
non-pharmacological therapy
older adults
quality of life
cognition
neurocognitive disorders
randomised controlled trial
mood
depression
anxiety
memory
Additional relevant MeSH terms:
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Dementia
Disease
Cognitive Dysfunction
Neurocognitive Disorders
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Cognition Disorders