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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Coimbra, Portugal, 3004-011
        • The Health Sciences Research Unit: Nursing

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Group intervention
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.
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.
Behavioral: Group intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cognition (person with cognitive decline)
Time Frame: Pre-intervention (baseline)
Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
Pre-intervention (baseline)
Change in depressive dymptomatology (person with cognitive decline)
Time Frame: Pre-intervention (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.
Pre-intervention (baseline)
Change in quality of life (person with cognitive decline)
Time Frame: Pre-intervention (baseline)
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.
Pre-intervention (baseline)
Change in cognition (person with cognitive decline)
Time Frame: 8 weeks post baseline
Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
8 weeks post baseline
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
Change in quality of life (person with cognitive decline)
Time Frame: Pre-intervention (baseline), 8 weeks post baseline
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.
Pre-intervention (baseline), 8 weeks post baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paulo Costa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Junta de Freguesia de Santo António dos Olivais
Centro Sociocultural Polivalente de São Martinho
Centro Social e Paroquial de Carapinheira do Campo
Obra Social de Torre de Vilela
Centro Social Paroquial de Pedrulha
Associação Nacional de Apoio ao Idoso
Santa Casa de Misericórdia de Cantanhede
Doce Viver - Residencial Sénior, Bruscos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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