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

NCT04658394 | Completed

• 1 other identifier: 21112020
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 13

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.

Conditions

Dementia; Neurocognitive Disorders; Cognitive Impairment; Cognitive Dysfunction; Cognitive Decline

Keywords

older adults; dementia; reminiscence therapy; quality of life; cognition; neurocognitive disorders; individual therapy; non-pharmacological therapy; randomised controlled trial; mood; depression; anxiety; memory

Outcome Measures

Primary Outcomes (3)

• Cognitive functioning evaluated through Mini-Mental State Examination [MMSE]

  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.

  baseline

• Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]

  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.

  13 weeks after the beginning of the intervention

• Change in cognitive functioning evaluated through Mini-Mental State Examination [MMSE]

  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.

  12 weeks after end of intervention

Secondary Outcomes (15)

• Quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]

  baseline

• Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]

  13 weeks after the beginning of the intervention

• Change in quality of life evaluated through Quality of Life - Alzheimer's Disease [QoL-AD]

  12 weeks after end of intervention

• Anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]

  baseline

• Change in anxiety symptomatology assessed through the Geriatric Anxiety Inventory [GAI]

  13 weeks after the beginning of the intervention

Other Outcomes (2)

• Sociodemographic information gathered through the sociodemographic questionnaire

  baseline

• Functional dependence evaluated through Barthel Index [IB]

  before baseline (exclusion criteria)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Reminiscence therapy OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rsocialform - Geriatria, Lda: lead

Study Sites (13)

Rsocialform - Geriatria, Lda.

Mealhada, Aveiro District, 3050-387, Portugal

Location

Santa Casa da Misericórdia da Horta

Horta, Faial, 9900-033, Portugal

Location

Santa Casa da Misericórdia de Santa Cruz das Flores

Santa Cruz das Flores, Flores, Portugal

Location

Santa Casa da Misericórdia de Lajes do Pico

Lajes, Pico, 9930-126, Portugal

Location

Santa Casa da Misericórdia da Madalena do Pico

Madalena, Pico, 9950-322, Portugal

Location

Santa Casa da Misericórdia de Vila do Porto

Vila do Porto, Santa Maria, 9580-528, Portugal

Location

Santa Casa da Misericórdia da Calheta

Calheta, São Jorge, 9850-070, Portugal

Location

Casa de Repouso João Inácio de Sousa

Velas, São Jorge, 9800-559, Portugal

Location

Casa do Povo de Arrifes

Arrifes, São Miguel, 9500-377, Portugal

Location

Casa do Povo da Maia

Maia, São Miguel, 9625-320, Portugal

Location

Lar Luis Soares de Sousa de Ponta Delgada

Ponta Delgada, São Miguel, Portugal

Location

Santa Casa da Misericórdia de Angra do Heroísmo

Angra do Heroísmo, Terceira, 9700-020, Portugal

Location

Lar D. Pedro V

Praia da Vitória, Terceira, 9760-438, Portugal

Location

Related Publications (47)

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MeSH Terms

Conditions

Dementia; Neurocognitive Disorders; Cognitive Dysfunction; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 8, 2020
• Study Start: February 11, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (13)