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Multicentre Study About the Effect of Individual Reminiscence Therapy

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: NCT04047238
Recruitment Status : Completed
First Posted : August 6, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Rsocialform - Geriatria, Lda

Brief Summary:
This study aims to evaluate the effect of individual reminiscence therapy (RT) on the global cognitive function of people with neurocognitive disorders attending social responses and to evaluate the ability of individually applied reminiscence therapy (RT) to improve overall cognitive function, memory, executive function, mood and quality of life (QoL) of elderly people with neurocognitive impairment attending social responses. It is proposed a multicenter study with an experimental design with randomized controlled repeated measures. Participants in the intervention group will hold two RT sessions per week for three months. Control group participants will maintain their treatment as usual.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Randomized Controlled Study About the Effect of Individual Reminiscence Therapy on Cognition in Elderly People With Neurocognitive Disorder Attending Social Responses
Actual Study Start Date : August 8, 2019
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Arm Intervention/treatment
Experimental: Intervention Group
Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving Reminiscence Therapy or to a control group receiving treatment as usual. Participants in the intervention group will participate in two Reminiscence Therapy sessions per week for 3 months besides their treatment as usual. The sessions will be based on the Book of Past and Present and they will follow the same protocol in every participant institution.
Other: Reminiscence Therapy

Intervention group will receive two Reminiscence Therapy sessions per week for 3 months. Reminiscence therapy 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 Reminiscence Therapy. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of Past and 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 [ Time Frame: Pre and post-intervention (3 months) ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Mini-Mental State Examination is a brief cognitive screening test. Scores range between 0 - 30 points. Higher scores indicate better cognitive function.


Secondary Outcome Measures :
  1. Memory funtion evaluated through Memory Alteration Test [ Time Frame: Pre and post-intervention (3 months) ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Memory Alteration Test is an easy and fast instrument that assesses five memory domains: orientation in time, short term memory, semantic memory, free recall and recall with clues. Scores range between 0 - 50 points. Higher scores indicate better memory.

  2. Executive functions evaluated through Frontal Assessment Battery [ Time Frame: Pre and post-intervention (3 months) ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Frontal Assessment Battery assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function.

  3. Mood evaluated through Geriatric Depression Scale -15 [ Time Frame: Pre and post-intervention (3 months) ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Geriatric Depression Scale -15 is composed by 15 yes/no answer items and it has good psychometric characteristics to assess depression in older people. Scores range between 0 - 15 points. Higher scores indicate more severe depressive symptoms.

  4. Quality of life evaluated through Quality of Life - Alzheimer's Disease [ Time Frame: Pre and post-intervention (3 months) ]
    Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychossocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.



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 diagnostic of a neurocognitive disorder according to the DSM-5 criteria.
  • To have delivered the informed consent of the project, duly completed and signed, after prior information
  • Capacity to communicate and understand.
  • Possibility of gathering information about the participant's life history through their relatives or habitual caregivers, using the socio-familiar questionnaire design for that purpose.
  • Being 65 years of age or older.
  • Being a native Portuguese speaker.
  • Regularly attend a social response institution that provides services for the elderly.

Exclusion Criteria:

  • To suffer from an acute or severe illness that makes it impossible for them to participate in the intervention sessions.
  • Serious sensory and physical limitations that prevent the participation in the sessions.
  • Severe disconnection with the environment and very limited attention span.
  • Presence of severe neuropsychiatric symptoms, such as hyperactivity, psychosis, severe depressive and anxiety symptoms and apathy, that prevent participation in the sessions or presence of uncontrolled delirium.
  • Traumatic life history or marked by negative events relevant to the person that discourage the participation in the Reminiscence Therapy sessions.
  • History of negative reactions during previous Reminiscence Therapy sessions or similar activities.

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): NCT04047238


Locations
Show Show 25 study locations
Sponsors and Collaborators
Rsocialform - Geriatria, Lda
Investigators
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Principal Investigator: Susana I Justo Henriques, PhD Cediara and University of de Santiago de Compostela
Principal Investigator: Enrique Pérez Sáez, PhD CRE Alzheimer and University of Salamanca
Principal Investigator: João L Alves Apóstolo, PhD Nursing School of Coimbra
Publications:
Apóstolo JLA, Loureiro LMJ, Reis IAC, Silva IALL, Cardoso DFB, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referência IV(3): 65-73, 2014. doi: 10.12707/RIV14033.
Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental State Examination. Sinapse 2: 10-16, 2009.
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 1: 106-125, 2010. 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 7: 167-173, 2007. 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 29: 93-97, 2002. 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 30: 697-721, 2010. doi: 10.1017/S0144686X09990328.
Apóstolo JLA, Bobrowicz-Campos M, 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 23: 99-107, 2018. doi: 10.5944/rppc.vol.23.num.2.2018.21050.
Guerreiro M, Silva AP, Botelho MA, Leitão O, Castro-Caldas A, Garcia. Adaptação à população portuguesa da tradução do Mini Mental State Examination (MMSE). Revista Portuguesa de Neurologia 1: 9-10, 1994.
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 5: 21-32, 1999.
Morgan S, Woods RT. Life review with people with dementia in care homes: A preliminary randomized controlled trial. Non-pharmacological Therapies in Dementia 1: 43-60, 2010.

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Responsible Party: Rsocialform - Geriatria, Lda
ClinicalTrials.gov Identifier: NCT04047238    
Other Study ID Numbers: 01082019
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: August 2019
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
Cognitive Impairment
Cognitive Decline
Neurocognitive Disorders
Elderly
Reminiscence Therapy
Individual Intervention
Cognition
Depression
Quality of Life
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Cognition Disorders