Self- EfficacyNCT05802043
Effect of Cognitive Stimulating Interventions on Cognitive Self-Efficacy and Sense of Happiness Among Older Adults
A study testing Cognitive Stimulating Interventions in people with Self- Efficacy, run by Alexandria University at 1 site in Egypt.
Trial summary
The present study aims to determine the effect of cognitive stimulation interventions on cognitive self-efficacy and sense of happiness among older adults. Research hypothesis: Older adults who receive the cognitive stimulation interventions exhibit higher cognitive self-efficacy and sense of happiness than those who… Read more about this study
- Who is it for?
- Ages 60 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Self- Efficacy
- What is being tested?
- Cognitive Stimulating Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2023to 10 Feb 2023
- 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 60 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 7. Have pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Stimulating Interventions Improve Cognitive Self- Efficacy and Sense of Happiness Among Older Adults
The present study aims to determine the effect of cognitive stimulation interventions on cognitive self-efficacy and sense of happiness among older adults.
Research hypothesis:
Older adults who receive the cognitive stimulation interventions exhibit higher cognitive self-efficacy and sense of happiness than those who do not receive it.
Read the detailed description
A convenient sample of eighty (80) older adults will be used according Epi info V 7.0 program calculation based on the following statistical parameters ; Population size: 250, expected frequency: 50%, confidence coefficient: 95%, acceptable error: 10%, minimum sample size = 70.
The study will include eighty (80) older adults aged 60 years and more and fulfilling the following criteria:
Inclusion criteria
- Aged 60 years and old.
- Able to read and write.
- Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State Examination Scale (MMSE).
- Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS_SF).
- Accept participation in the study. 6. Available at the selected setting during the time of data collection. 7. Have no pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.
The selected study subjects (80) will be randomly assigned to two equal groups of 40 older adults each as flows; Group 1, study group: include older adults who will receive the proposed interventions, cognitive stimulation interventions.
Group 2, control group: include older adults who will receive the routine activities of the elderly club.
- Conditions
- Self- Efficacy
- Being tested
- Cognitive Stimulating Interventions
- Keywords
- Sense of Happiness, Cognitive Stimulating Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stimulating InterventionsBehavioural
a quasi-experimental research design.The study subjects of group 1, the study group, will receive the proposed interventions, the cognitive stimulation interventions through small groups of study subjects receiving 12 sessions of group activities (2 sessions/week, approximately 45- 60 minutes/session). A group size of 6 to 8 will be conducted. The interventions group will be conducted in activity rooms within the elderly club.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Stimulating Interventions | Experimental | The study interventions will be developed by the researchers based on review of the related literature and with reference to the CST manual (Spector, et al., 2006), and review on Cognitive Stimulation (Woods et al., 2012). The study subjects of group 1, the study group, will receive the proposed interventions, the cognitive stimulation interventions through small groups of study subjects receiving 12 sessions of group activities (2 sessions/week, approximately 45- 60 minutes/session). A group size of 6 to 8 will be conducted. The interventions group will be conducted in activity rooms within the elderl club. The study subjects group 2, the control group, will receive the routine activities of the elderly club. The researchers will provide the control group with written materials related the essential cognitive stimulation interventions after ending the implementation of the proposed interventions for the study group. Receives: Behavioral: Cognitive Stimulating Interventions |
| Routine Club care | Active comparator | The study subjects group 2, the control group, will receive the routine activities of the elderly club.The researchers will provide the control group with written materials related the essential cognitive stimulation interventions after ending the implementation of the proposed interventions for the study group, Receives: Behavioral: Cognitive Stimulating Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
I) Mini-Mental State Examination (MMS) Scale
The MMS scale was developed by Folestein et al., (1975). It used to assess cognitive function of the older adults. It contained questions concerning registration, orientation, calculation, recall, attention, and language. The MMS scale score was 30 point and classified as follows: -30. -23. -17.
The MMS was translated into Arabic and approved to be valid and reliable (r=0.96) by El Husseini (2008). The Arabic version of this scale was used in the present study.
Measured: 2 weeks
Secondary outcomes (1)
II) Geriatric Depression Scale- Short Form (GDS-SF)
The Geriatric Depression Scale - short Form (GDS-SF), a self-report tool with 15-item developed by Yesavage et al. (1983) to assess general well-being and depression in the elderly. The older adults should select one answer either yes (1) or no (0) for their feelings over the past week. The scores ranged from 0 to 15. Items' score will be calculated for the total score. A score of 0 to 4 meant no depression, score of 5 to 8 meant mild depression, score of 9 to 11 meant moderate depression, and 12-15 meant severe depression.
The GDS-SF was translated into Arabic and approved to be reliable (r=0.70) and valid by ElHusseini (2013). The Arabic version of this scale was used in the current study.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start17 Jan 2023
- Primary completion1 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Self- EfficacyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Taha, professor, Study chair, Egypt Faculty of Nursing Alexandria, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802043
- Sponsor's protocol ID
- 15012023
- Status last verified
- Jan 2023
- First submitted
- 25 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apostolo J, Bobrowicz-Campos E, Holland C, Cano A. One small step in frailty research, a giant leap in evidence based practice. JBI Database System Rev Implement Rep. 2018 Jan;16(1):1-3. doi: 10.11124/JBISRIR-2017-003672. No abstract available.
PubMed 29324548Coen RF, Flynn B, Rigney E, O'Connor E, Fitzgerald L, Murray C, Dunleavy C, McDonald M, Delaney D, Merriman N, Edgeworth J. Efficacy of a cognitive stimulation therapy programme for people with dementia. Ir J Psychol Med. 2011 Sep;28(3):145-147. doi: 10.1017/S0790966700012131.
PubMed 30200025Feng L, Zin Nyunt MS, Gao Q, Feng L, Yap KB, Ng TP. Cognitive Frailty and Adverse Health Outcomes: Findings From the Singapore Longitudinal Ageing Studies (SLAS). J Am Med Dir Assoc. 2017 Mar 1;18(3):252-258. doi: 10.1016/j.jamda.2016.09.015. Epub 2016 Nov 9.
PubMed 27838339Kelly ME, Finan S, Lawless M, Scully N, Fitzpatrick J, Quigley M, Tyrrell F, O'Regan A, Devane A. An evaluation of community-based cognitive stimulation therapy: a pilot study with an Irish population of people with dementia. Ir J Psychol Med. 2017 Sep;34(3):157-167. doi: 10.1017/ipm.2016.23.
PubMed 30115146
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Stimulating Interventions Improve Cognitive Self- Efficacy and Sense of Happiness Among Older Adults
- ClinicalTrials.gov ID
- NCT05802043
- Acronym / sponsor ID
- 15012023
- Conditions
- Self- Efficacy
- Keywords
- Sense of Happiness, Cognitive Stimulating Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 6 Apr 2023 (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.
The present study aims to determine the effect of cognitive stimulation interventions on cognitive self-efficacy and sense of happiness among older adults.
Research hypothesis:
Older adults who receive the cognitive stimulation interventions exhibit higher cognitive self-efficacy and sense of happiness than those who do not receive it.
Detailed description
A convenient sample of eighty (80) older adults will be used according Epi info V 7.0 program calculation based on the following statistical parameters ; Population size: 250, expected frequency: 50%, confidence coefficient: 95%, acceptable error: 10%, minimum sample size = 70.
The study will include eighty (80) older adults aged 60 years and more and fulfilling the following criteria:
Inclusion criteria
- Aged 60 years and old.
- Able to read and write.
- Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State Examination Scale (MMSE).
- Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS_SF).
- Accept participation in the study. 6. Available at the selected setting during the time of data collection. 7. Have no pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.
The selected study subjects (80) will be randomly assigned to two equal groups of 40 older adults each as flows; Group 1, study group: include older adults who will receive the proposed interventions, cognitive stimulation interventions.
Group 2, control group: include older adults who will receive the routine activities of the elderly club.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Stimulating Interventions | Experimental | Behavioral: Cognitive Stimulating InterventionsThe study interventions will be developed by the researchers based on review of the related literature and with reference to the CST manual (Spector, et al., 2006), and review on Cognitive Stimulation (Woods et al., 2012). The study subjects of group 1, the study group, will receive the proposed interventions, the cognitive stimulation interventions through small groups of study subjects receiving 12 sessions of group activities (2 sessions/week, approximately 45- 60 minutes/session). A group size of 6 to 8 will be conducted. The interventions group will be conducted in activity rooms within the elderl club. The study subjects group 2, the control group, will receive the routine activities of the elderly club. The researchers will provide the control group with written materials related the essential cognitive stimulation interventions after ending the implementation of the proposed interventions for the study group. |
| Routine Club care | Active comparator | Behavioral: Cognitive Stimulating InterventionsThe study subjects group 2, the control group, will receive the routine activities of the elderly club.The researchers will provide the control group with written materials related the essential cognitive stimulation interventions after ending the implementation of the proposed interventions for the study group, |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 7. Have pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.
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 |
|---|---|---|
| Cognitive Stimulating Interventionsa quasi-experimental research design.The study subjects of group 1, the study group, will receive the proposed interventions, the cognitive stimulation interventions through small groups of study subjects receiving 12 sessions of group activities (2 sessions/week, approximately 45- 60 minutes/session). A group size of 6 to 8 will be conducted. The interventions group will be conducted in activity rooms within the elderly club. | Behavioural | Cognitive Stimulating Interventions, Routine Club care |
Primary outcome
I) Mini-Mental State Examination (MMS) Scale
Time frame: 2 weeks
The MMS scale was developed by Folestein et al., (1975). It used to assess cognitive function of the older adults. It contained questions concerning registration, orientation, calculation, recall, attention, and language. The MMS scale score was 30 point and classified as follows: -30. -23. -17. The MMS was translated into Arabic and approved to be valid and reliable (r=0.96) by El Husseini (2008). The Arabic version of this scale was used in the present study.
1 secondary outcome
II) Geriatric Depression Scale- Short Form (GDS-SF)
Time frame: 2 weeks
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 6 Apr 2023.
- Background: PubMed 29324548Apostolo J, Bobrowicz-Campos E, Holland C, Cano A. One small step in frailty research, a giant leap in evidence based practice. JBI Database System Rev Implement Rep. 2018 Jan;16(1):1-3. doi: 10.11124/JBISRIR-2017-003672. No abstract available.
- Background: PubMed 30200025Coen RF, Flynn B, Rigney E, O'Connor E, Fitzgerald L, Murray C, Dunleavy C, McDonald M, Delaney D, Merriman N, Edgeworth J. Efficacy of a cognitive stimulation therapy programme for people with dementia. Ir J Psychol Med. 2011 Sep;28(3):145-147. doi: 10.1017/S0790966700012131.
- Background: PubMed 27838339Feng L, Zin Nyunt MS, Gao Q, Feng L, Yap KB, Ng TP. Cognitive Frailty and Adverse Health Outcomes: Findings From the Singapore Longitudinal Ageing Studies (SLAS). J Am Med Dir Assoc. 2017 Mar 1;18(3):252-258. doi: 10.1016/j.jamda.2016.09.015. Epub 2016 Nov 9.
- Background: PubMed 30115146Kelly ME, Finan S, Lawless M, Scully N, Fitzpatrick J, Quigley M, Tyrrell F, O'Regan A, Devane A. An evaluation of community-based cognitive stimulation therapy: a pilot study with an Irish population of people with dementia. Ir J Psychol Med. 2017 Sep;34(3):157-167. doi: 10.1017/ipm.2016.23.
- Individual participant dataSharing planned: No
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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.
Eman Taha, professor study chair
Egypt Faculty of Nursing Alexandria, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stimulating Interventions in people with Self- Efficacy, run by Alexandria University at 1 site in Egypt.
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 0 inclusion and 1 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 6 Apr 2023. 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 Egypt. 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?
I) Mini-Mental State Examination (MMS) Scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802043, which also lists 4 linked publications.
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 6 Apr 2023.