- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05802043
Effect of Cognitive Stimulating Interventions on Cognitive Self-Efficacy and Sense of Happiness Among Older Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alexandria, Egypt, 21523
- Faculty of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:1. Aged 60 years and old. 2. Able to read and write. 3. Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State Examination Scale (MMSE).
4. Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS_SF).
5. Accept participation in the study. 6. Available at the selected setting during the time of data collection.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Cognitive Stimulating Interventions
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.
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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.
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Active Comparator: Routine Club care
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,
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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. |
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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II) Geriatric Depression Scale- Short Form (GDS-SF)
Time Frame: 2 weeks
|
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. |
2 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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III) Six -Domains Perceived Cognitive Self-Efficacy for Older Adults Structured Interview Questionnaire
Time Frame: 2 weeks
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This tool will be developed by the researchers to assess the cognitive self-efficacy among older adults.
It composed of 40 items related to six domains covering six cognitive functions (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided attention).
Each domain contains several cognitive task related to this domain.
Older adults asked to rate how certain they are that they can do each cognitive task.
They rate the degree of confidence in their cognitive abitity by recording a number from 0 to 10, next to each statement, where 0 means cannot do at all, 5 moderately certain can do, and 10 indicates highly certain can do.the
total score ranges from 0 to 400.
The higher the score is the higher cognitive self-efficacy.
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2 weeks
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IV) The Subjective Happiness Scale (SHS):
Time Frame: 2 weeks
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The Subjective Happiness Scale is a 4-item scale that developed by Lyubomirsky, et al., (1999) to measure subjective happiness.
Each item is completed by choosing one of 7 options that finish a given sentence fragment.
The options are different for each of the four questions.
Two items ask respondents to characterize themselves using both absolute ratings and ratings relative to peers, whereas the other two items offer brief descriptions of happy and unhappy individuals and ask respondents the extent to which each characterization describes them.
The average of the item scores is an overall measure sense of happiness with high scores indicating greater sense of happiness.
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2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eman Taha, professor, Egypt Faculty of Nursing Alexandria, Egypt
Publications and helpful links
General 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.
- Coen 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.
- Feng 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.
- Kelly 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 15012023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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