Sleep ProblemNCT04719598
Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Problems Among Sample of Post- Menopausal
A study testing congnitive behavioural therapy in people with Sleep Problem, run by Jouf University.
Trial summary
Sleep problems become more prominent with aging and worse among post-menopause than perimenopause stage. The actual causes of sleep problems are unclear. However, it occurs commonly accompanied with or in the response of seriousness of menpausal symptoms as nocturnal hot flashes, mood disorders, and obstructive sleep… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Sleep Problem
- What is being tested?
- congnitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2021to 15 Jun 2021
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopaused women age between 50 and65 years
- Able to read and write
- Being normally ( primary ) menopause at least one year
- Willing to give written informed consent to participate in the study.
- Women obtaining more than 5 of the total score of the Pittsburgh Sleep Quality Index (PSQI)( that indicates poor sleep )
- Have smartphone with internet access (WhatsApp) application
Who cannot join
- Has serious physical disorders or uncontrolled conditions as uncontrolled blood pressure , uncontrolled blood glucose level, on hemodialysis
- Receiving psychotropic medications, hormone replacement therapy (HRT),
- Undergoing hysterectomy
- Has acute or chronic surgical conditions, cancer or any other serious illness
- Has cognitive impairments or physical handicap
- Giving prescribed or non-prescribed medication or herbals that influencing sleep .
About this study
Official title: Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Quality Among a Sample of Saudi Postmenopausal Women
Sleep problems become more prominent with aging and worse among post-menopause than perimenopause stage. The actual causes of sleep problems are unclear. However, it occurs commonly accompanied with or in the response of seriousness of menpausal symptoms as nocturnal hot flashes, mood disorders, and obstructive sleep apnea among menopauses. The Prevalence of sleep problems is variable ranged from 11.8 -62 % based on different studies.
Cognitive-behavioral therapy (CBT) is one of the short-term form of psychotherapy, used for managing sleep problems and insomnia , an efficacious as pharmacological treatment.
Read the detailed description
As life expectancy has increased, women spend more than one-third of their lives in menopausal transition (MT) and the subsequent post menopause (PM).As a result of hormonal changes women experiences such symptoms as hot flashes, mood swings, anxiety, and sexual dysfunction that deteriorate their quality of life. Those symptoms usually begin in 45-53-year-olds and it varies in onset and severity from women to another and from country to another.
Symptoms of sleep problems include the difficulty of falling asleep, fractioned sleep, night-time awakening, the inability of resuming sleep, problems in waking up, fatigue, and daytime sleepiness that potentiate poor physical and mental quality of life.
The goal of CBT is to teach women how to modify maladaptive behaviors and thoughts that may contribute to a particular problem as sleep problems, anxious thoughts, and vasomotor symptoms
- Conditions
- Sleep Problem
- Being tested
- congnitive behavioural therapy
- Keywords
- Post menopausal, intervention, sleep problems, CBT
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
congnitive behavioural therapyBehavioural
Also called non
CBT Sessions divide into three main components; 1) cognitive interventions, concerns with cognitive restructuring attempts to change maladaptive thought about thoughts about sleep into more adaptable . 2) Behavioral intervention: concerns with Relaxation training, stimulus control, and sleep restriction promote relaxation and help to establish healthy sleep habits. 3) Psychoeducational interventions: Providing information about the connection between thoughts, feelings, behaviors, and sleep.
| Study group | Role | What they receive |
|---|---|---|
| intervention group is ( internet - based group) who will receive CBT sessions | Experimental | study group ( group A) Receives: Behavioral: congnitive behavioural therapy |
| control group ( group B) | No intervention | researchers just answer their questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
change sleep quality post intervention
improve quality of sleep than before intervention before intervention
Measured: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
change insomnia related to post menpausal symptoms post intervention
decrease insomnia index score post intervention
Measured: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
Secondary outcomes (1)
change menopausal symptoms post intervention
decrease menopausal rating scale post intervention than pre intervention
Measured: at the end of intervention program ( 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Jan 2021 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one intervention group ( internet-based cognitive behavioral therapy) and one control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Mahrous AbdelAziz, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719598
- Sponsor's protocol ID
- 1384754968
- Status last verified
- Jan 2021
- First submitted
- 25 Dec 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Quality Among a Sample of Saudi Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04719598
- Acronym / sponsor ID
- 1384754968
- Conditions
- Sleep Problem
- Keywords
- Post menopausal, intervention, sleep problems, CBT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 22 Jan 2021 (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.
Sleep problems become more prominent with aging and worse among post-menopause than perimenopause stage. The actual causes of sleep problems are unclear. However, it occurs commonly accompanied with or in the response of seriousness of menpausal symptoms as nocturnal hot flashes, mood disorders, and obstructive sleep apnea among menopauses. The Prevalence of sleep problems is variable ranged from 11.8 -62 % based on different studies.
Cognitive-behavioral therapy (CBT) is one of the short-term form of psychotherapy, used for managing sleep problems and insomnia , an efficacious as pharmacological treatment.
Detailed description
As life expectancy has increased, women spend more than one-third of their lives in menopausal transition (MT) and the subsequent post menopause (PM).As a result of hormonal changes women experiences such symptoms as hot flashes, mood swings, anxiety, and sexual dysfunction that deteriorate their quality of life. Those symptoms usually begin in 45-53-year-olds and it varies in onset and severity from women to another and from country to another.
Symptoms of sleep problems include the difficulty of falling asleep, fractioned sleep, night-time awakening, the inability of resuming sleep, problems in waking up, fatigue, and daytime sleepiness that potentiate poor physical and mental quality of life.
The goal of CBT is to teach women how to modify maladaptive behaviors and thoughts that may contribute to a particular problem as sleep problems, anxious thoughts, and vasomotor symptoms
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- one intervention group ( internet-based cognitive behavioral therapy) and one control group
| Arm | Type | Receives |
|---|---|---|
| intervention group is ( internet - based group) who will receive CBT sessions | Experimental | Behavioral: congnitive behavioural therapystudy group ( group A) |
| control group ( group B) | No intervention | –researchers just answer their questions |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Menopaused women age between 50 and65 years
- Able to read and write
- Being normally ( primary ) menopause at least one year
- Willing to give written informed consent to participate in the study.
- Women obtaining more than 5 of the total score of the Pittsburgh Sleep Quality Index (PSQI)( that indicates poor sleep )
Key exclusion criteria (6 listed)
- Has serious physical disorders or uncontrolled conditions as uncontrolled blood pressure , uncontrolled blood glucose level, on hemodialysis
- Receiving psychotropic medications, hormone replacement therapy (HRT),
- Undergoing hysterectomy
- Has acute or chronic surgical conditions, cancer or any other serious illness
- Has cognitive impairments or physical handicap
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 |
|---|---|---|
| congnitive behavioural therapyAlso: nonCBT Sessions divide into three main components; 1) cognitive interventions, concerns with cognitive restructuring attempts to change maladaptive thought about thoughts about sleep into more adaptable . 2) Behavioral intervention: concerns with Relaxation training, stimulus control, and sleep restriction promote relaxation and help to establish healthy sleep habits. 3) Psychoeducational interventions: Providing information about the connection between thoughts, feelings, behaviors, and sleep. | Behavioural | intervention group is ( internet - based group) who will receive CBT sessions |
Primary outcome
change sleep quality post intervention
Time frame: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
improve quality of sleep than before intervention before intervention
change insomnia related to post menpausal symptoms post intervention
Time frame: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
decrease insomnia index score post intervention
1 secondary outcome
change menopausal symptoms post intervention
Time frame: at the end of intervention program ( 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing congnitive behavioural therapy in people with Sleep Problem, run by Jouf University.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 sleep quality post intervention (time frame: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)). 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?
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 2 Feb 2021.