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Multicentre Study About the Effect of Individual Reminiscence Therapy

Primary Purpose

Cognitive Impairment, Cognitive Decline, Dementia

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Reminiscence Therapy
Sponsored by
Rsocialform - Geriatria, Lda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring Dementia, Cognitive Impairment, Cognitive Decline, Neurocognitive Disorders, Elderly, Reminiscence Therapy, Individual Intervention, Cognition, Depression, Quality of Life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cediara - Assoc. Sol. Social de Ribeira de Fráguas
  • Rsocialform - Geriatria, Lda.
  • Santa Casa Da Misericórdia de Ovar
  • Lar D. Pedro V
  • Delicate Age Lda.
  • APARSIN - Assoc. Port. de Apoio e Reabilitação Sénior de Intervenção Neurológica
  • Santa Casa Da Misericordia de Almada - Centro São Lázaro
  • Centro Social Vale Do Homem
  • Santa Casa Da Misericórdia de Vila Verde
  • Centro Zulmira Pereira Simões
  • Santa Casa Da Misericórdia de Castelo Branco
  • Santa Casa Da Misericórdia de Vila Velha de Ródão
  • Centro Social Paroquial Dornelas
  • Primavida Residência Sénior Amor
  • Santa Casa Da Misericórdia de Alcobaça
  • Santa Casa Da Misericórdia Do Alvorge
  • Associação Alzheimer Portugal
  • Irmãs Hospitaleiras - Casa de Saúde Da Idanha
  • Centro Social de Tolosa
  • Centro Social Paroquial Recarei
  • Associação de Solidariedade Social S. Tiago de Rebordões
  • Santa Casa Da Misericordia de Coruche
  • Santa Casa Da Misericórdia de Melgaço
  • Santa Casa Da Misericórdia de Vouzela
  • Pesqueiramiga- Associação de Solidariedade Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Memory funtion evaluated through Memory Alteration Test
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.
Executive functions evaluated through Frontal Assessment Battery
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.
Mood evaluated through Geriatric Depression Scale -15
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.
Quality of life evaluated through Quality of Life - Alzheimer's Disease
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.

Full Information

First Posted
August 2, 2019
Last Updated
February 14, 2020
Sponsor
Rsocialform - Geriatria, Lda
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1. Study Identification

Unique Protocol Identification Number
NCT04047238
Brief Title
Multicentre Study About the Effect of Individual Reminiscence Therapy
Official Title
Multicentre Randomized Controlled Study About the Effect of Individual Reminiscence Therapy on Cognition in Elderly People With Neurocognitive Disorder Attending Social Responses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rsocialform - Geriatria, Lda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reminiscence Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive functioning evaluated through Mini-Mental State Examination
Description
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.
Time Frame
Pre and post-intervention (3 months)
Secondary Outcome Measure Information:
Title
Memory funtion evaluated through Memory Alteration Test
Description
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.
Time Frame
Pre and post-intervention (3 months)
Title
Executive functions evaluated through Frontal Assessment Battery
Description
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.
Time Frame
Pre and post-intervention (3 months)
Title
Mood evaluated through Geriatric Depression Scale -15
Description
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.
Time Frame
Pre and post-intervention (3 months)
Title
Quality of life evaluated through Quality of Life - Alzheimer's Disease
Description
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.
Time Frame
Pre and post-intervention (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana I Justo Henriques, PhD
Organizational Affiliation
Cediara and University of de Santiago de Compostela
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrique Pérez Sáez, PhD
Organizational Affiliation
CRE Alzheimer and University of Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
João L Alves Apóstolo, PhD
Organizational Affiliation
Nursing School of Coimbra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cediara - Assoc. Sol. Social de Ribeira de Fráguas
City
Albergaria-a-Velha
State/Province
Aveiro
ZIP/Postal Code
3850-705
Country
Portugal
Facility Name
Rsocialform - Geriatria, Lda.
City
Mealhada
State/Province
Aveiro
ZIP/Postal Code
3050-387
Country
Portugal
Facility Name
Santa Casa Da Misericórdia de Ovar
City
Ovar
State/Province
Aveiro
ZIP/Postal Code
3880-225
Country
Portugal
Facility Name
Lar D. Pedro V
City
Praia da Vitória
State/Province
Açores
ZIP/Postal Code
9760-458
Country
Portugal
Facility Name
Delicate Age Lda.
City
Portimão
State/Province
Faro
ZIP/Postal Code
8500-684
Country
Portugal
Facility Name
APARSIN - Assoc. Port. de Apoio e Reabilitação Sénior de Intervenção Neurológica
City
Elvas
State/Province
Portalegre
ZIP/Postal Code
7350
Country
Portugal
Facility Name
Santa Casa Da Misericordia de Almada - Centro São Lázaro
City
Almada
State/Province
Setúbal
ZIP/Postal Code
2800-119
Country
Portugal
Facility Name
Centro Social Vale Do Homem
City
Braga
ZIP/Postal Code
4730-263
Country
Portugal
Facility Name
Santa Casa Da Misericórdia de Vila Verde
City
Braga
ZIP/Postal Code
4730-416
Country
Portugal
Facility Name
Centro Zulmira Pereira Simões
City
Braga
ZIP/Postal Code
4750-650
Country
Portugal
Facility Name
Santa Casa Da Misericórdia de Castelo Branco
City
Castelo Branco
ZIP/Postal Code
6000-773
Country
Portugal
Facility Name
Santa Casa Da Misericórdia de Vila Velha de Ródão
City
Castelo Branco
ZIP/Postal Code
6030-230
Country
Portugal
Facility Name
Centro Social Paroquial Dornelas
City
Guarda
ZIP/Postal Code
3570-130
Country
Portugal
Facility Name
Primavida Residência Sénior Amor
City
Leiria
ZIP/Postal Code
2400-792
Country
Portugal
Facility Name
Santa Casa Da Misericórdia de Alcobaça
City
Leiria
ZIP/Postal Code
2460-009
Country
Portugal
Facility Name
Santa Casa Da Misericórdia Do Alvorge
City
Leiria
ZIP/Postal Code
3240-407
Country
Portugal
Facility Name
Associação Alzheimer Portugal
City
Lisboa
ZIP/Postal Code
1300-125
Country
Portugal
Facility Name
Irmãs Hospitaleiras - Casa de Saúde Da Idanha
City
Lisboa
ZIP/Postal Code
2605-077
Country
Portugal
Facility Name
Centro Social de Tolosa
City
Portalegre
ZIP/Postal Code
6050-501
Country
Portugal
Facility Name
Centro Social Paroquial Recarei
City
Porto
ZIP/Postal Code
4585-905
Country
Portugal
Facility Name
Associação de Solidariedade Social S. Tiago de Rebordões
City
Porto
Country
Portugal
Facility Name
Santa Casa Da Misericordia de Coruche
City
Santarém
ZIP/Postal Code
2100-111
Country
Portugal
Facility Name
Santa Casa Da Misericórdia de Melgaço
City
Viana Do Castelo
ZIP/Postal Code
4960-529
Country
Portugal
Facility Name
Santa Casa Da Misericórdia de Vouzela
City
Viseu
ZIP/Postal Code
3670-257
Country
Portugal
Facility Name
Pesqueiramiga- Associação de Solidariedade Social
City
Viseu
ZIP/Postal Code
5130-376
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
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Multicentre Study About the Effect of Individual Reminiscence Therapy

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