Multicentre Study About the Effect of Individual Reminiscence Therapy

February 14, 2020 updated by: Rsocialform - Geriatria, Lda

Multicentre Randomized Controlled Study About the Effect of Individual Reminiscence Therapy on Cognition in Elderly People With Neurocognitive Disorder Attending Social Responses

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neurocognitive disorder is a major cause of disability among older people and its incidence is increasing due to an aging population. Neurocognitive disorders globally are estimated to affect 44.35 million people and it is expected that by the year 2050 the number of affected people globally will triple to 135.46 million.

The absence of effective pharmacological treatment that stops or slows down the development of the disease has aroused interest in non-pharmacological therapies as a complement to pharmacological treatment that may improve the quality of life of people with neurocognitive disorders. One of the most investigated and most traditional non-pharmacological therapy in this field is Reminiscence Therapy (RT).

RT involves discussing past activities, events and experiences, usually with the help of triggers, such as photographs, household objects and other familiar items from the past, music… that is, any object or stimulus that serves to stimulate remembrance. In its application to dementia, RT is based on the fact that the memory impairment of people with dementia means that they are able to recall events from their past life, especially from childhood to early adulthood, but cannot remember more recent facts. It focuses on preserved memories and abilities, promotes communication, and enables the person to connect with his/her past and regain his/her sense of personal identity. Thus, RT can be understood as an intervention on the edge of those of cognitive orientation and emotion-centered, with potential interactive effects on autobiographical memory and psychological well-being.

The investigators can distinguish at least two RT approaches. The first one is the "life review" where participants are guided through meaningful experiences from their biography trying to make sense of their life. This type of RT is more structured and is usually conducted in an individual format. It may imply the construction of "life books". This approach is considered to have an integrative function aimed at achieving a sense of validation, coherence and reconciliation with the person's past. Another approach is the simple reminiscence which involves the stimulation of autobiographical memory during conversations about specific themes of the past (such as holidays, food and drinks, work…) using stimuli that trigger memories. It has been described as an unstructured narrative of autobiographical memories. This reminiscence format can be conducted both individually and in groups and promotes communication between participants who share their memories and stories.

In any of the TR formats it is essential to introduce triggering stimuli (photographs, music, antique objects…) to aid in recall. These triggers may be generic, reflecting common experiences in the lives of people relevant to their age group (for example a textbook may serve to recall the experience during their school stage), or specific, with stimuli related to the individual's own experiences (for example photographs of an important life event such as your wedding day or a trip during your youth).

Regarding the effectiveness of RT, according to a recent Cochrane review, there is some evidence for its positive effects on cognition, QoL, communication, and possibly mood of people with dementia, although benefits are small. Despite the distinction between the two different approaches to RT (simple reminiscence vs. life review), the modality of therapy does not seem to be as important for positive effects as the individual or group format of the sessions and the context in which the intervention is administered (people who live in the community or people who are institutionalized).

According to the results of one review study, RT seems to be able to generate a small benefit on cognitive function immediately after the intervention, although it usually does not persist after a follow-up period. Regarding the administration format, individual RT effects seems slightly superior on cognition both immediately and after a follow-up period. In any case, its effects appear to be comparable to those of other cognitive stimulation therapies.

As for the effect of RT on QoL, a life-review-based individual RT study showed an improvement in Qol-AD. Effects with a group format do not seem consistent, showing little or no effect on QoL, although the key factor may be the application context (community vs. institution), with better results of group RT in institutionalized patients.

Group RT was associated with an effect on communication both after the intervention and at follow-up. This effect was not replicated in individual RT, with uncertain results.

Finally, despite evidence of the effect of RT on mood of older people without dementia, in the case of people with dementia only a small effect on mood was found for those participants. in individual RT.

Therefore, this research proposal aims to evaluate the ability of individual RT using a simple reminiscence format to improve the overall cognitive function, memory, executive function, mood and quality of life (QoL) of people with neurocognitive disorder attending social responses for the elderly.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Braga, Portugal, 4730-263
        • Centro Social Vale do Homem
      • Braga, Portugal, 4730-416
        • Santa Casa Da Misericórdia de Vila Verde
      • Braga, Portugal, 4750-650
        • Centro Zulmira Pereira Simões
      • Castelo Branco, Portugal, 6000-773
        • Santa Casa da Misericórdia de Castelo Branco
      • Castelo Branco, Portugal, 6030-230
        • Santa Casa Da Misericórdia de Vila Velha de Ródão
      • Guarda, Portugal, 3570-130
        • Centro Social Paroquial Dornelas
      • Leiria, Portugal, 2400-792
        • Primavida Residência Sénior Amor
      • Leiria, Portugal, 2460-009
        • Santa Casa da Misericórdia de Alcobaça
      • Leiria, Portugal, 3240-407
        • Santa Casa Da Misericórdia Do Alvorge
      • Lisboa, Portugal, 1300-125
        • Associação Alzheimer Portugal
      • Lisboa, Portugal, 2605-077
        • Irmãs Hospitaleiras - Casa de Saúde da Idanha
      • Portalegre, Portugal, 6050-501
        • Centro Social de Tolosa
      • Porto, Portugal
        • Associação de Solidariedade Social S. Tiago de Rebordões
      • Porto, Portugal, 4585-905
        • Centro Social Paroquial Recarei
      • Santarém, Portugal, 2100-111
        • Santa Casa da Misericórdia de Coruche
      • Viana Do Castelo, Portugal, 4960-529
        • Santa Casa da Misericórdia de Melgaço
      • Viseu, Portugal, 3670-257
        • Santa Casa da Misericórdia de Vouzela
      • Viseu, Portugal, 5130-376
        • Pesqueiramiga- Associação de Solidariedade Social
    • Aveiro
      • Albergaria-a-Velha, Aveiro, Portugal, 3850-705
        • Cediara - Assoc. Sol. Social de Ribeira de Fráguas
      • Mealhada, Aveiro, Portugal, 3050-387
        • Rsocialform - Geriatria, Lda.
      • Ovar, Aveiro, Portugal, 3880-225
        • Santa Casa Da Misericórdia de Ovar
    • Açores
      • Praia da Vitória, Açores, Portugal, 9760-458
        • Lar D. Pedro V
    • Faro
      • Portimão, Faro, Portugal, 8500-684
        • Delicate Age Lda.
    • Portalegre
      • Elvas, Portalegre, Portugal, 7350
        • APARSIN - Assoc. Port. de Apoio e Reabilitação Sénior de Intervenção Neurológica
    • Setúbal
      • Almada, Setúbal, Portugal, 2800-119
        • Santa Casa Da Misericordia de Almada - Centro São Lázaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre and post-intervention (3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre and post-intervention (3 months)
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.
Pre and post-intervention (3 months)
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.
Pre and post-intervention (3 months)
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.
Pre and post-intervention (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rsocialform - Geriatria, Lda

Investigators

  • Principal Investigator: Susana I Justo Henriques, PhD, Cediara and University of de Santiago de Compostela
  • Principal Investigator: Enrique Pérez Saéz, PhD, CRE Alzheimer and University of Salamanca
  • Principal Investigator: João L Alves Apóstolo, PhD, Nursing School of Coimbra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01082019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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