An interventional study of cognitive behavioral therapy and Usual Care Group in Stroke, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
Stroke is a major cause of long-term disability among older adults and may negatively affect self-efficacy, sleep quality, and fatigue. This study aims to evaluate the effect of a Cognitive Behavioral Therapy (CBT) program on self-efficacy, sleep quality, and fatigue in older adults after stroke. A total of 90 geriatric patients will be allocated to two groups: a study group receiving CBT in addition to usual care and a control group receiving usual care only. The CBT program will consist of seven modules delivered over eight individual sessions. Outcomes will be assessed at baseline and at one and two months after completion of the intervention using the Stroke Self-Efficacy Questionnaire, Pittsburgh Sleep Quality Index, and Fatigue Severity Scale. The findings are expected to provide evidence regarding the potential benefits of CBT in improving recovery-related outcomes and quality of life among older adults after stroke.
Phase I: Preparatory phase:
This phase included a review of literature, developing the study tools as well as testing the content validity and reliability of the study tools.
1. Administrative:
- Ethical approval will be obtained from the Research Ethics Committee of the Faculty of Nursing, Mansoura University.
Permission to conduct the study will be obtained from the responsible authorities of the study setting after explaining the aim and procedure of the study.
2. Review of literature:
This will include a review of the past and current related literature and studies, using available books, periodicals, magazines and articles to become aware of the various aspects of the research problem.
3. Developing the study tools and Cognitive Behavioral Therapy (CBT) program:
The training will be performed once every week, including an educational session and a practical session, depending on geriatric patients' adherence and level of understanding.
4. Validity of the study tools:
Phase II: The exploratory phase:
It will include a pilot study and fieldwork.
Pilot study:
- A pilot study will be carried out on 10% of the total sample size (n = 9) to demonstrate the feasibility and applicability of the tools and to estimate the time needed for data collection. Geriatric patients who will be included in the pilot study will be excluded from the study sample.
Fieldwork:
Data collection period
- The researcher will start by introducing herself to the geriatric patients and giving them a brief idea about the aim and the nature of the study.
- The framework of the study will be carried out through four stages as follows:
Assessment phase:
Using all study tools, an initial assessment will be done to ensure that all geriatric patients are screened to confirm that they meet the inclusion criteria and are free from the exclusion criteria.
Planning phase:
- Geriatric patients will be divided into the study group (n = 45) and the control group (n = 45) by the researcher using the block randomization method (divided into block A and block B). In this way, the same number of geriatric patients in the study group and in the control group will be ensured. Geriatric patients in the study group will receive the CBT intervention, which will be delivered according to a standardized treatment manual comprising seven modules addressing fatigue and sleep over eight individual therapy sessions. The intervention will encompass the core CBT principles of psychoeducation, behavioral activation, behavioral experiments, cognitive restructuring, problem solving, and relapse prevention.
Implementation phase:
Each geriatric patient will be interviewed to collect baseline data using the study tools, and each geriatric patient in the study group will be given an educational session before starting the training sessions.
Outcomes will be evaluated one month and two months post-intervention.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 90 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
study group: involves patients who will receive cognitive behavioral therapy - program which include 7 modules delivering across 8 sessions, addressing maladaptive beliefs and behaviors perpetuating sleep and fatigue symptoms. Also, this program will contain adaptations for common cognitive impairments after stroke, by using session structure, concrete concepts, regular repetition, explicit discussion as to how homework use of reminders, written handouts, and additional support from therapists to identify unhelpful thought patterns or behaviors , training performed once every week including educational session and practical session depending on geriatric patient adherence and their level of understanding.
Behavioral: cognitive behavioral therapy
Participants continued to receive usual post-stroke care as provided by the clinic, without CBT e.g., routine follow-up, medication management, supportive counseling.
Other: Usual Care Group
Cognitive behavioral therapy program will include 7 modules delivering across 8 sessions, addressing maladaptive beliefs and behaviors perpetuating sleep and fatigue symptoms. Also, this program will contain adaptations for common cognitive impairments after stroke, by using session structure, concrete concepts, regular repetition, explicit discussion as to how homework use of reminders, written handouts, and additional support from therapists to identify unhelpful thought patterns or behaviors
Participants continue to receive usual post-stroke care as provided by the clinic (e.g., routine follow-up, medication management, supportive counseling), without the cognitive behavioral therapy program.
Stroke Self Efficacy Questionnaire
The Stroke Self-Efficacy Questionnaire was developed to measure self-efficacy after stroke. It was translated into Arabic and validated, and it has been shown to be reliable. Its reliability was tested using test-retest reliability with Spearman's correlation coefficient (r = 0.84). It consists of 13 statements divided into two domains: activity (items 1-8) and self-management (items 9-13). Responses are rated on a 4-point Likert scale: 0 = not at all confident, 1 = slightly confident, 2 = moderately confident, and 3 = very confident. Subscale scores are obtained by summing the responses. The possible range is 0-24 for the activity domain, 0-15 for the self-management domain, and 0-39 for the total perceived self-efficacy score. A higher score indicates higher self-efficacy.
Time frame: Baseline, 1 month and 2 months after completion of the intervention
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in older adults. It was translated into Arabic and validated, and it has been shown to be reliable. Its reliability was tested using test-retest reliability with Spearman's correlation coefficient (r = 0.83). It differentiates poor from good sleep by measuring seven domains: subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. The patient self-rates each of these seven areas of sleep. Answers are scored on a 0-3 point Likert scale, where 3 reflects the negative extreme. The component scores are summed to produce a global score (range 0-21); higher scores indicate worse sleep quality. A total score of 5 or greater indicates poor sleep quality.
Time frame: Baseline, 1 month and 2 months after completion of the intervention
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) was originally developed to assess the severity of fatigue and its effect on a person's activities and lifestyle in patients with several types of disorders. It was translated into Arabic and validated. Its reliability was evaluated using Cronbach's alpha (α = 0.902). The self-report scale includes nine statements concerning fatigue, its intensity, and how it affects specific activities. Answers are rated on a seven-point Likert scale, where 1 denotes strong disagreement and 7 denotes strong agreement. Thus, the lowest possible total score is 9 and the highest is 63. Scoring interpretation: the mean of all item scores is calculated, with a possible range of 1 to 7. A cutoff score of 4 or higher suggests problematic fatigue, whereas a score of 5 or higher signifies severe fatigue.
Time frame: Baseline, 1 month and 2 months after completion of the intervention
Plan to share: No — Individual participant data will not be shared with other researchers to protect participants' privacy and confidentiality. Only aggregated study results may be reported in publications.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.