Cognitive ReserveNCT07744178
Nurse-led Intervention for Cognitive Reserve and Stress Management
A study testing Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management) in people with Cognitive Reserve, run by Cairo University at 1 site in Egypt.
Trial summary
As people approach retirement, leaving the workplace can reduce the mental, social, and physical stimulation that a demanding job provides, while also introducing new stress related to the transition. Read more about this study
- Who is it for?
- Ages 55 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Reserve
- What is being tested?
- Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2026
- 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 55 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed teacher at one of the four participating public primary schools in Kafr El-Dawwar, Beheira Governorate, Egypt
- Able to communicate in Arabic
- Willing and able to provide written informed consent
Who cannot join
- Declined to participate or did not provide written informed consent
- Participation in pilot testing of the study instruments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-led Intervention for Cognitive Reserve and Stress Management for Teachers Approaching Retirement: a Cluster-randomized Controlled Trial
As people approach retirement, leaving the workplace can reduce the mental, social, and physical stimulation that a demanding job provides, while also introducing new stress related to the transition. Both changes may affect long-term brain health and well-being, yet there is little evidence on programs that address them together before retirement particularly programs delivered by nurses in the workplace.
This study tested whether a brief, nurse-led group program could improve cognitive reserve (the mental resources that help a person maintain thinking ability despite age-related brain changes) and reduce perceived stress among primary school teachers aged 55 to 69 who were still working and approaching retirement. The four-week program combined cognitive-stimulation activities, stress-management and relaxation training, gentle psychomotor (movement and coordination) exercises, and guided planning for staying mentally, physically, and socially active after retirement. Teachers in the comparison group continued their usual activities and received an educational booklet after the program ended.
The trial used a cluster-randomized controlled design conducted in four public primary schools in Kafr El-Dawwar, Beheira Governorate, Egypt. Whole schools rather than individual teachers were randomly assigned, so that two schools received the program and two served as controls. Cognitive reserve and perceived stress were measured at baseline, immediately after the program, and again at 4 weeks, 3 months, and 6 months of follow-up.
Read the detailed description
This interventional trial evaluated a nurse-led, workplace-based approach to supporting cognitive and psychological health during the pre-retirement period - a life stage in which changes to daily structure, occupational complexity, social contact, and role identity may influence later cognitive trajectories and stress. The rationale drew on cognitive-reserve theory together with evidence that persistent perceived stress can constrain the behavioral expression of reserve; the two prespecified outcomes were therefore evaluated concurrently rather than as independent targets. Development followed Medical Research Council guidance for complex interventions, and the intervention was specified using the Template for Intervention Description and Replication (TIDieR).
The school served as the unit of randomization, while the individual teacher was the unit of recruitment, delivery, and measurement. To limit selection bias, all eligible teachers within each participating school were invited and individual recruitment was completed before the allocation sequence was generated. A researcher responsible for the statistical analysis then generated the school-level sequence by computer, assigned schools 1:1 to conditions, and informed schools of their allocation afterward. Delivering the program at the level of the whole school was intended to reduce exchange of intervention materials between conditions (contamination). Because the program was educational and behavioral, participants and the nurse interventionists could not be masked; masking of outcome assessment and analysis was not undertaken, and both outcomes were self-reported.
The intervention was developed by the research team and reviewed by faculty experts in community-health, psychiatric mental-health, and gerontological nursing for content, cultural suitability, sequence, and feasibility. Standardized materials - an illustrated Arabic booklet, visual aids, activity materials, brief instructional videos, and session checklists supported consistent delivery. Two nurse-researchers rehearsed manualized session scripts and standardized timing, activity administration, attendance recording, and documentation of protocol deviations before implementation. Facilitators used content checklists to confirm delivery of planned objectives and to log any deviations in content or duration.
The primary analysis used complete-case linear mixed-effects models with fixed effects for group, time (as a categorical factor), and their interaction, plus a participant-level random intercept, estimated by restricted maximum likelihood. Because the archived analysis file did not contain the school identifier, these models accounted for repeated measures within participants but not for clustering of teachers within schools; with only four clusters, cluster-level variance and conventional asymptotic standard errors may be unstable. Inferential results are therefore interpreted as exploratory and are supported by two post hoc sensitivity analyses: a cluster-precision analysis applying a design-effect adjustment across a range of plausible intracluster correlation coefficients, and a series of progressively adverse missing-outcome scenarios. No a priori cluster-adjusted sample-size calculation was performed; census-style recruitment was used, and interpretation emphasizes effect estimates and their uncertainty rather than post hoc power.
- Conditions
- Cognitive Reserve
- Being tested
- Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management)Other
Nurse-Led Multicomponent Program (Behavioral)
A brief multicomponent program delivered by two nurse-researchers over four consecutive weeks, comprising 12 group sessions: 8 cognitive-stimulation sessions (twice weekly) and 4 psychomotor and stress-interventiosessions (once weekly). Sessions lasted approximately 45-60 minutes in groups of no more than 8 teachers and followed a standardized sequence of orientation, facilitator demonstration, guided practice, feedback, and brief home practice. Cognitive-interventio sessions targeted memory, language, attention, and executive function through structured tasks (storytelling, verbal-fluency exercises, memory and board games, problem-solving, and writing/drawing activities). Psychomotor and stress-interventi sessions addressed posture, balance, coordination, and ergonomics alongside coping skills, relaxation, mindfulness-informed practice, and behavioral action planning. Post-retirement behavioral planning was integrated across all four week
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: | Experimental | Intervention arm:
Participants received a brief multicomponent program delivered by two nurse-researchers over four consecutive weeks, comprising 12 group sessions: 8 cognitive-intervention sessions (twice weekly) and 4 psychomotor and stress-intervention sessions (once weekly). Sessions lasted approximately 45-60 minutes in groups of no more than 8 teachers, following a standardized sequence of orientation, demonstration, guided practice, feedback, and brief home practice. Cognitive-intervention sessions targeted memory, language, attention, and executive function; psychomotor and stress-intervention sessions addressed posture, balance, coordination, and ergonomics alongside coping skills, relaxation, mindfulness-informed practice, and behavioral action planning. Post-retirement behavioral planning was integrated across all four weeks. Reinforcement included an Arabic illustrated booklet, visual aids, brief instructional videos, home practice, and SMS reminders. Receives: Other: Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management) |
| Control arm - Usual Activities with Delayed Booklet Participants continued their usual educational | No intervention | Control arm: Participants in the control schools continued their usual educational and occupational activities during the four-week program period and did not receive the structured cognitive-intervention sessions, psychomotor training, stress-intervention instruction, text-message reminders, or assigned home practice given to the intervention arm. The standardized educational booklet was provided to control schools only after the immediate post-program assessment, so later follow-up contrasts reflect the full program versus delayed booklet exposure rather than unchanged usual activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Reserve Assessment Scale in Health (CRASH)
The Cognitive Reserve Assessment Scale in Health (CRASH) is a 33-item self-report instrument covering education, occupational attainment, and intellectual and leisure activities. The global score is calculated using the validated weighted-domain formula [(education × 6) + (occupation × 11.25) + leisure] / 3. Total scores range from 0 to 90, with higher scores indicating greater cognitive reserve-related exposure. The total score is analyzed as a continuous variable; no data-derived categories or cut-off values are applied.
Measured: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
Secondary outcomes (1)
Change in 10-item Perceived Stress Scale (PSS-10)
The 10-item Perceived Stress Scale (PSS-10) measures the extent to which respondents appraise their lives during the previous month as unpredictable, uncontrollable, and overloaded. Each item is rated from 0 (never) to 4 (very often). Items 4, 5, 7, and 8 are reverse-scored before summation. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. The total score is analyzed as a continuous variable; no diagnostic cut-off values are applied.
Measured: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ReserveStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mahmoud Seif EL-Nasr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744178
- Sponsor's protocol ID
- CairoU EMSiefEL-Nasr
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Intervention for Cognitive Reserve and Stress Management for Teachers Approaching Retirement: a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07744178
- Acronym / sponsor ID
- CairoU EMSiefEL-Nasr
- Conditions
- Cognitive Reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 4 Aug 2026 (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.
As people approach retirement, leaving the workplace can reduce the mental, social, and physical stimulation that a demanding job provides, while also introducing new stress related to the transition. Both changes may affect long-term brain health and well-being, yet there is little evidence on programs that address them together before retirement particularly programs delivered by nurses in the workplace.
This study tested whether a brief, nurse-led group program could improve cognitive reserve (the mental resources that help a person maintain thinking ability despite age-related brain changes) and reduce perceived stress among primary school teachers aged 55 to 69 who were still working and approaching retirement. The four-week program combined cognitive-stimulation activities, stress-management and relaxation training, gentle psychomotor (movement and coordination) exercises, and guided planning for staying mentally, physically, and socially active after retirement. Teachers in the comparison group continued their usual activities and received an educational booklet after the program ended.
The trial used a cluster-randomized controlled design conducted in four public primary schools in Kafr El-Dawwar, Beheira Governorate, Egypt. Whole schools rather than individual teachers were randomly assigned, so that two schools received the program and two served as controls. Cognitive reserve and perceived stress were measured at baseline, immediately after the program, and again at 4 weeks, 3 months, and 6 months of follow-up.
Detailed description
This interventional trial evaluated a nurse-led, workplace-based approach to supporting cognitive and psychological health during the pre-retirement period - a life stage in which changes to daily structure, occupational complexity, social contact, and role identity may influence later cognitive trajectories and stress. The rationale drew on cognitive-reserve theory together with evidence that persistent perceived stress can constrain the behavioral expression of reserve; the two prespecified outcomes were therefore evaluated concurrently rather than as independent targets. Development followed Medical Research Council guidance for complex interventions, and the intervention was specified using the Template for Intervention Description and Replication (TIDieR).
The school served as the unit of randomization, while the individual teacher was the unit of recruitment, delivery, and measurement. To limit selection bias, all eligible teachers within each participating school were invited and individual recruitment was completed before the allocation sequence was generated. A researcher responsible for the statistical analysis then generated the school-level sequence by computer, assigned schools 1:1 to conditions, and informed schools of their allocation afterward. Delivering the program at the level of the whole school was intended to reduce exchange of intervention materials between conditions (contamination). Because the program was educational and behavioral, participants and the nurse interventionists could not be masked; masking of outcome assessment and analysis was not undertaken, and both outcomes were self-reported.
The intervention was developed by the research team and reviewed by faculty experts in community-health, psychiatric mental-health, and gerontological nursing for content, cultural suitability, sequence, and feasibility. Standardized materials - an illustrated Arabic booklet, visual aids, activity materials, brief instructional videos, and session checklists supported consistent delivery. Two nurse-researchers rehearsed manualized session scripts and standardized timing, activity administration, attendance recording, and documentation of protocol deviations before implementation. Facilitators used content checklists to confirm delivery of planned objectives and to log any deviations in content or duration.
The primary analysis used complete-case linear mixed-effects models with fixed effects for group, time (as a categorical factor), and their interaction, plus a participant-level random intercept, estimated by restricted maximum likelihood. Because the archived analysis file did not contain the school identifier, these models accounted for repeated measures within participants but not for clustering of teachers within schools; with only four clusters, cluster-level variance and conventional asymptotic standard errors may be unstable. Inferential results are therefore interpreted as exploratory and are supported by two post hoc sensitivity analyses: a cluster-precision analysis applying a design-effect adjustment across a range of plausible intracluster correlation coefficients, and a series of progressively adverse missing-outcome scenarios. No a priori cluster-adjusted sample-size calculation was performed; census-style recruitment was used, and interpretation emphasizes effect estimates and their uncertainty rather than post hoc power.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: | Experimental | Other: Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management)Intervention arm: Participants received a brief multicomponent program delivered by two nurse-researchers over four consecutive weeks, comprising 12 group sessions: 8 cognitive-intervention sessions (twice weekly) and 4 psychomotor and stress-intervention sessions (once weekly). Sessions lasted approximately 45-60 minutes in groups of no more than 8 teachers, following a standardized sequence of orientation, demonstration, guided practice, feedback, and brief home practice. Cognitive-intervention sessions targeted memory, language, attention, and executive function; psychomotor and stress-intervention sessions addressed posture, balance, coordination, and ergonomics alongside coping skills, relaxation, mindfulness-informed practice, and behavioral action planning. Post-retirement behavioral planning was integrated across all four weeks. Reinforcement included an Arabic illustrated booklet, visual aids, brief instructional videos, home practice, and SMS reminders. |
| Control arm - Usual Activities with Delayed Booklet Participants continued their usual educational | No intervention | –Control arm: Participants in the control schools continued their usual educational and occupational activities during the four-week program period and did not receive the structured cognitive-intervention sessions, psychomotor training, stress-intervention instruction, text-message reminders, or assigned home practice given to the intervention arm. The standardized educational booklet was provided to control schools only after the immediate post-program assessment, so later follow-up contrasts reflect the full program versus delayed booklet exposure rather than unchanged usual activity. |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employed teacher at one of the four participating public primary schools in Kafr El-Dawwar, Beheira Governorate, Egypt
- Able to communicate in Arabic
- Willing and able to provide written informed consent
Key exclusion criteria (2 listed)
- Declined to participate or did not provide written informed consent
- Participation in pilot testing of the study instruments
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 |
|---|---|---|
| Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management)Nurse-Led Multicomponent Program (Behavioral) A brief multicomponent program delivered by two nurse-researchers over four consecutive weeks, comprising 12 group sessions: 8 cognitive-stimulation sessions (twice weekly) and 4 psychomotor and stress-interventiosessions (once weekly). Sessions lasted approximately 45-60 minutes in groups of no more than 8 teachers and followed a standardized sequence of orientation, facilitator demonstration, guided practice, feedback, and brief home practice. Cognitive-interventio sessions targeted memory, language, attention, and executive function through structured tasks (storytelling, verbal-fluency exercises, memory and board games, problem-solving, and writing/drawing activities). Psychomotor and stress-interventi sessions addressed posture, balance, coordination, and ergonomics alongside coping skills, relaxation, mindfulness-informed practice, and behavioral action planning. Post-retirement behavioral planning was integrated across all four week | Other | Intervention arm: |
Primary outcome
Change in Cognitive Reserve Assessment Scale in Health (CRASH)
Time frame: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
The Cognitive Reserve Assessment Scale in Health (CRASH) is a 33-item self-report instrument covering education, occupational attainment, and intellectual and leisure activities. The global score is calculated using the validated weighted-domain formula [(education × 6) + (occupation × 11.25) + leisure] / 3. Total scores range from 0 to 90, with higher scores indicating greater cognitive reserve-related exposure. The total score is analyzed as a continuous variable; no data-derived categories or cut-off values are applied.
1 secondary outcome
Change in 10-item Perceived Stress Scale (PSS-10)
Time frame: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
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 16 Sep 2026.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management) in people with Cognitive Reserve, run by Cairo 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 3 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 16 Sep 2026. 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?
Change in Cognitive Reserve Assessment Scale in Health (CRASH) (time frame: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion). 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 16 Sep 2026.