Multicentre Study About the Effect of Individual Reminiscence Therapy

NCT04047238 | Completed

• 1 other identifier: 01082019
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 25

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.

Conditions

Cognitive Impairment; Cognitive Decline; Dementia; Neurocognitive Disorders

Keywords

Dementia; Cognitive Impairment; Cognitive Decline; Neurocognitive Disorders; Elderly; Reminiscence Therapy; Individual Intervention; Cognition; Depression; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Cognitive functioning evaluated through Mini-Mental State Examination

  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.

  Pre and post-intervention (3 months)

Secondary Outcomes (4)

• Memory funtion evaluated through Memory Alteration Test

  Pre and post-intervention (3 months)

• Executive functions evaluated through Frontal Assessment Battery

  Pre and post-intervention (3 months)

• Mood evaluated through Geriatric Depression Scale -15

  Pre and post-intervention (3 months)

• Quality of life evaluated through Quality of Life - Alzheimer's Disease

  Pre and post-intervention (3 months)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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 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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rsocialform - Geriatria, Lda: lead

Study Sites (25)

Cediara - Assoc. Sol. Social de Ribeira de Fráguas

Albergaria-a-Velha, Aveiro District, 3850-705, Portugal

Location

Rsocialform - Geriatria, Lda.

Mealhada, Aveiro District, 3050-387, Portugal

Location

Santa Casa Da Misericórdia de Ovar

Ovar, Aveiro District, 3880-225, Portugal

Location

Lar D. Pedro V

Praia da Vitória, Azores, 9760-458, Portugal

Location

Delicate Age Lda.

Portimão, Faro District, 8500-684, Portugal

Location

APARSIN - Assoc. Port. de Apoio e Reabilitação Sénior de Intervenção Neurológica

Elvas, Portalegre District, 7350, Portugal

Location

Santa Casa Da Misericordia de Almada - Centro São Lázaro

Almada, Setúbal District, 2800-119, Portugal

Location

Centro Social Vale Do Homem

Braga, 4730-263, Portugal

Location

Santa Casa Da Misericórdia de Vila Verde

Braga, 4730-416, Portugal

Location

Centro Zulmira Pereira Simões

Braga, 4750-650, Portugal

Location

Santa Casa Da Misericórdia de Castelo Branco

Castelo Branco, 6000-773, Portugal

Location

Santa Casa Da Misericórdia de Vila Velha de Ródão

Castelo Branco, 6030-230, Portugal

Location

Centro Social Paroquial Dornelas

Guarda, 3570-130, Portugal

Location

Primavida Residência Sénior Amor

Leiria, 2400-792, Portugal

Location

Santa Casa Da Misericórdia de Alcobaça

Leiria, 2460-009, Portugal

Location

Santa Casa Da Misericórdia Do Alvorge

Leiria, 3240-407, Portugal

Location

Associação Alzheimer Portugal

Lisbon, 1300-125, Portugal

Location

Irmãs Hospitaleiras - Casa de Saúde Da Idanha

Lisbon, 2605-077, Portugal

Location

Centro Social de Tolosa

Portalegre, 6050-501, Portugal

Location

Centro Social Paroquial Recarei

Porto, 4585-905, Portugal

Location

Associação de Solidariedade Social S. Tiago de Rebordões

Porto, Portugal

Location

Santa Casa Da Misericordia de Coruche

Santarém, 2100-111, Portugal

Location

Santa Casa Da Misericórdia de Melgaço

Viana do Castelo, 4960-529, Portugal

Location

Santa Casa Da Misericórdia de Vouzela

Viseu, 3670-257, Portugal

Location

Pesqueiramiga- Associação de Solidariedade Social

Viseu, 5130-376, Portugal

Location

Related Publications (39)

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MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Neurocognitive Disorders; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: August 8, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 18, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (25)