CClinicalTrials.gg
CompletedNCT07744178Updated Sep 16, 2026

Nurse-led Intervention for Cognitive Reserve and Stress Management

An interventional study of Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management) in Cognitive Reserve, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 55 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
55 Years to 69 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cognitive Reserve
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Declined to participate or did not provide written informed consent
  • Participation in pilot testing of the study instruments
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    Intervention arm:

    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.

    Other: Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management)

  • No intervention
    Control arm - Usual Activities with Delayed Booklet Participants continued their usual educational

    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.

Interventions

  • OtherNurse-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

06

What researchers measure

Primary outcomes

  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.

    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

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.

    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

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07744178
Lead sponsor
Cairo University
Responsible party
Eman Mahmoud Seif EL-Nasr (Assistant Professor of Community Health Nursing, Faculty of Nursing, Cairo University, Cairo University) — Principal investigator
First posted
Aug 4, 2026
Start date
Jan 1, 2025
Primary completion
Aug 1, 2025
Completion
Jan 1, 2026
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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