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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Cairo University

    Cairo

Other trials in Egypt

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.

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 groups in NCT07744178
Study groupRoleWhat they receive
Intervention arm:ExperimentalIntervention 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 educationalNo interventionControl 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.

  1. 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)
  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.

  1. First posted4 Aug 2026
  2. Study start1 Jan 2025
  3. Primary completion1 Aug 2025
  4. Study completion1 Jan 2026

Resources

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)
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

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.

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