- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187572
Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline (TRvsCS)
January 7, 2022 updated by: Paulo Costa
Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline: a Quasi-experimental Pilot Study
Although data suggest that non-pharmacologic therapies such as Reminiscence Therapy (RT) and Cognitive Stimulation (CS) can potentially maintain or reverse this trend, cognitive impairment can be a precursor to neurodegenerative processes.
This study aimed to assess how an RT and a CS program affected cognition, depressive symptomatology, and quality of life (QoL) in older persons with cognitive decline who attended community support institutions in central Portugal.
For seven weeks, a quasi-experimental study with two arms (RT and CS program) was conducted.
The intervention was completed by 76 of the 109 older persons who were first screened (50 in the RT program, 26 in the CS program).
In both groups, a pre- and post-intervention analysis revealed statistically significant differences in cognition, particularly in older adults' delayed recall ability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
106
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
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Coimbra, Portugal, 3004-011
- The Health Sciences Research Unit: Nursing
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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
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability to give informed consent before study commencement;
- Ability to participate in group activities for a period between 45 to 60 minutes;
- No pronounced impairment of their visual and auditory abilities;
- Mild to moderate cognitive decline, assessed as a score equal to or below 20 points in the Six-Item Cognitive Impairment Test (6-CIT).
Exclusion Criteria:
- Unstable clinical condition;
- Prescribed with cholinesterase inhibitors and/or antipsychotics during the study period.
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Reminiscence Therapy (RT)
The RT program is composed of activities that follow older adults' lifespan (e.g., school, professional life, travelling, holidays and celebrations, historical dates/moments).
Such activities allow older adults to revive and share life-changing/significant moments and integrate them into their autobiographical narrative.
The program was developed and validated by Gil and colleagues for Portuguese older adults with cognitive decline.
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This intervention was developed during 14 sessions, held twice a week, with a duration of 45 to 60 minutes each.
The sessions were developed as group-based interventions, facilitated by a leader and a co-leader from each community institution.
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EXPERIMENTAL: Cognitive Stimulation (CST)
The CST intervention was based on the "Making a Difference" program, specifically developed for older adults with cognitive decline and previously adapted and validated to the European Portuguese language and culture.
This program offers a sequence of activities that covers different cognitive domains and promotes older adults' socialization and self-esteem.
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This intervention was developed during 14 sessions, held twice a week, with a duration of 45 to 60 minutes each.
The sessions were developed as group-based interventions, facilitated by a leader and a co-leader from each community institution.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in cognition (person with cognitive decline)
Time Frame: Pre-intervention (baseline)
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Measured using the Montreal Cognitive Assessment (MoCA).
Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
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Pre-intervention (baseline)
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Change in depressive dymptomatology (person with cognitive decline)
Time Frame: Pre-intervention (baseline)
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Measured using the 10-items Geriatric Depression Scale (GDS-10).
Scale scores vary between 0 and 10 points; scores equal or above 2 points correspond to a screening diagnosis of depression.
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Pre-intervention (baseline)
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Change in quality of life (person with cognitive decline)
Time Frame: Pre-intervention (baseline)
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Measured using the World Health Organization Quality of Life - module for older adults (WHOQOL-OLD-8).
Scale scores vary between 8 and 40 points; higher scores correspond to a higher level of quality of life.
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Pre-intervention (baseline)
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Change in cognition (person with cognitive decline)
Time Frame: 8 weeks post baseline
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Measured using the Montreal Cognitive Assessment (MoCA).
Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
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8 weeks post baseline
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Change in depressive dymptomatology (person with cognitive decline)
Time Frame: 8 weeks post baseline
|
Measured using the 10-items Geriatric Depression Scale (GDS-10).
Scale scores vary between 0 and 10 points; scores equal or above 2 points correspond to a screening diagnosis of depression.
|
8 weeks post baseline
|
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Change in quality of life (person with cognitive decline)
Time Frame: Pre-intervention (baseline), 8 weeks post baseline
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Measured using the World Health Organization Quality of Life - module for older adults (WHOQOL-OLD-8).
Scale scores vary between 8 and 40 points; higher scores correspond to a higher level of quality of life.
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Pre-intervention (baseline), 8 weeks post baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Rosa Silva, PhD, Health Sciences Research Unit: Nursing, Nursing School of Coimbra
- Study Director: João Apóstolo, PhD, Health Sciences Research Unit: Nursing, 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.
Helpful Links
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)
April 20, 2017
Primary Completion (ACTUAL)
June 6, 2017
Study Completion (ACTUAL)
June 6, 2017
Study Registration Dates
First Submitted
December 21, 2021
First Submitted That Met QC Criteria
January 7, 2022
First Posted (ACTUAL)
January 12, 2022
Study Record Updates
Last Update Posted (ACTUAL)
January 12, 2022
Last Update Submitted That Met QC Criteria
January 7, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRvsCS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data presented in this study are available on request.
The data are not publicly available due to ethical considerations, regarding personal information and respecting what was written in the signed informed consent.
IPD Sharing Time Frame
The data presented in this study are available on request.
The data are not publicly available due to ethical considerations, regarding personal information and respecting what was written in the signed informed consent.
IPD Sharing Access Criteria
The data presented in this study are available on request.
The data are not publicly available due to ethical considerations, regarding personal information and respecting what was written in the signed informed consent.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
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.