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StrokeNCT07907107

Cognitive Behavioral Therapy for Self-Efficacy, Sleep Quality, and Fatigue After Stroke

A study testing cognitive behavioral therapy in people with Stroke, run by Mansoura 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

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Stroke
What is being tested?
cognitive behavioral therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
3 Mar 2026to 29 Sep 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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older adults aged 60 years or above, of both genders.
  • Available at the time of data collection.
  • Willing to participate in the study voluntarily.
  • Recent diagnosis of stroke.

Who cannot join

  • Comorbid neurological disorders, such as seizures.
  • Scheduled surgery during the period of data collection.
  • Currently undergoing a psychological treatment program.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Mansoura University Hospital

    Al Mansurah, Dakahlia Governorate, 35516

Other trials in Egypt

About this study

Official title: Effect of a Cognitive Behavioral Therapy Program on Self-Efficacy, Sleep Quality and Fatigue in Post-Stroke Geriatric Patients

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.

Read the detailed description

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.
  1. 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.
  1. Developing the study tools and Cognitive Behavioral Therapy (CBT) program:
  • Tool I: A Structured Interview Schedule will be developed by the researcher. Tool II: Stroke Self-Efficacy Questionnaire, Tool III: The Pittsburgh Sleep Quality Index (PSQI), and Tool IV: Fatigue Severity Scale (FSS) will be used in this study.
  • The CBT program will include seven modules delivered across eight sessions, addressing maladaptive beliefs and behaviors that perpetuate sleep and fatigue symptoms. The program will also contain adaptations for common cognitive impairments after stroke, including a structured session format, concrete concepts, regular repetition, explicit discussion of how to use reminders for homework, written handouts, and additional support from therapists to help patients identify unhelpful thought patterns or behaviors.
  • 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.
  1. Validity of the study tools:
  • Content validity of the study tools will be assessed and revised by a panel of five experts in the field of Gerontological nursing. The tools will be revised for clarity, content, sequence of items, and relevance of the content to measure the variables they are intended to measure. Suggestions of the jury members will be followed.

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:
  1. 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.
  2. 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.
  1. 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.
  2. Evaluation phase:

Outcomes will be evaluated one month and two months post-intervention.

Conditions
Stroke
Being tested
cognitive behavioral therapy, Usual Care Group
Keywords
Cognitive Behavioral Therapy, Self-Efficacy, Sleep Quality, Fatigue, Post-Stroke, Geriatric Patients
Medical subject headings
Stroke, Sleep Initiation and Maintenance Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive behavioral therapyBehavioural

    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

  • Usual Care GroupOther

    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.

Study groups in NCT07907107
Study groupRoleWhat they receive
study group have Cognitive Behavioral Therapy ProgramExperimentalstudy 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.
Receives: Behavioral: cognitive behavioral therapy
Control group: Usual Care GroupActive comparatorParticipants continued to receive usual post-stroke care as provided by the clinic, without CBT e.g., routine follow-up, medication management, supportive counseling.
Receives: Other: Usual Care Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 1 month and 2 months after completion of the intervention

  2. 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.

    Measured: Baseline, 1 month and 2 months after completion of the intervention

Secondary outcomes (1)

  1. 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.

    Measured: Baseline, 1 month and 2 months after completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start3 Mar 2026
  3. Primary completion27 Jul 2026
  4. Study completion29 Sep 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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A purposive sample of (90) post stroke geriatric patients who will be admitted to the neurological outpatient clinics at Mansoura University Hospital during the study period, will be included in this study. These patients will be randomly assigned into two matched groups: the study group, which will receive Cognitive Behavioral Therapy (CBT) in addition to usual care, and the control group, which will receive usual care only. Each group will consist of 45 older adults. Participants will be selected according to the following criteria: aged 60 years or above, of both genders, available at the time of data collection, willing to participate voluntarily, and with a recent diagnosis of stroke. Participants will be free from comorbid neurological disorders (such as seizures), will have no scheduled surgery during the data collection period, and will not be currently undergoing a psychological treatment program.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07907107
Sponsor's protocol ID
1281
Status last verified
Feb 2026
First submitted
21 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Chen W, Jiang T, Huang H, Zeng J. Post-stroke fatigue: a review of development, prevalence, predisposing factors, measurements, and treatments. Front Neurol. 2023 Dec 21;14:1298915. doi: 10.3389/fneur.2023.1298915. eCollection 2023.

    PubMed 38187145

  • Feigin VL, Brainin M, Norrving B, Martins SO, Pandian J, Lindsay P, F Grupper M, Rautalin I. World Stroke Organization: Global Stroke Fact Sheet 2025. Int J Stroke. 2025 Feb;20(2):132-144. doi: 10.1177/17474930241308142. Epub 2025 Jan 3.

    PubMed 39635884

  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

    PubMed 2803071

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Jones F, Partridge C, Reid F. The Stroke Self-Efficacy Questionnaire: measuring individual confidence in functional performance after stroke. J Clin Nurs. 2008 Apr;17(7B):244-52. doi: 10.1111/j.1365-2702.2008.02333.x.

    PubMed 18578800

  • Ahrens J, Shao R, Blackport D, Macaluso S, Viana R, Teasell R, Mehta S. Cognitive -behavioral therapy for managing depressive and anxiety symptoms after stroke: a systematic review and meta-analysis. Top Stroke Rehabil. 2023 May;30(4):368-383. doi: 10.1080/10749357.2022.2049505. Epub 2022 Mar 30.

    PubMed 35352629

Questions about this trial

What is this clinical trial studying?

A study testing cognitive behavioral therapy in people with Stroke, run by Mansoura 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 4 inclusion and 3 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 30 Oct 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?

Stroke Self Efficacy Questionnaire (time frame: Baseline, 1 month and 2 months after completion of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07907107, which also lists 6 linked publications.

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 30 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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