Cognitive DeclineTRvsCSNCT05187572
Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline
A study testing Group intervention in people with Cognitive Decline, run by Paulo Costa at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Apr 2017to 6 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- Unstable clinical condition;
- Prescribed with cholinesterase inhibitors and/or antipsychotics during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cognitive Decline
- Being tested
- Group intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reminiscence Therapy (RT) | Experimental | 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. Receives: Behavioral: Group intervention |
| Cognitive Stimulation (CST) | Experimental | 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. Receives: Behavioral: Group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition (person with cognitive decline)
Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
Measured: Pre-intervention (baseline)
Change in depressive dymptomatology (person with cognitive decline)
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.
Measured: Pre-intervention (baseline)
Change in quality of life (person with cognitive decline)
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.
Measured: Pre-intervention (baseline)
Change in cognition (person with cognitive decline)
Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
Measured: 8 weeks post baseline
Change in depressive dymptomatology (person with cognitive decline)
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.
Measured: 8 weeks post baseline
Change in quality of life (person with cognitive decline)
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.
Measured: Pre-intervention (baseline), 8 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start20 Apr 2017
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulo Costa
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Paulo Costa, Escola Superior de Enfermagem de Coimbra
- Investigators
- Rosa Silva, PhD, Study chair, Health Sciences Research Unit: Nursing, Nursing School of CoimbraJoão Apóstolo, PhD, Study director, Health Sciences Research Unit: Nursing, Nursing School of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187572
- Sponsor's protocol ID
- TRvsCS
- Acronym
- TRvsCS
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline: a Quasi-experimental Pilot Study
- ClinicalTrials.gov ID
- NCT05187572
- Acronym / sponsor ID
- TRvsCS / TRvsCS
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Paulo CostaUniversity, hospital or other
- Collaborators
- 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
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminiscence Therapy (RT) | Experimental | Behavioral: Group interventionThe 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. |
| Cognitive Stimulation (CST) | Experimental | Behavioral: Group interventionThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Unstable clinical condition;
- Prescribed with cholinesterase inhibitors and/or antipsychotics during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group interventionThis 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. | Behavioural | Cognitive Stimulation (CST), Reminiscence Therapy (RT) |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Silva, PhD study chair
Health Sciences Research Unit: Nursing, Nursing School of Coimbra
João Apóstolo, PhD study director
Health Sciences Research Unit: Nursing, Nursing School of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group intervention in people with Cognitive Decline, run by Paulo Costa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognition (person with cognitive decline) (time frame: Pre-intervention (baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.