Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Problems Among Sample of Post- Menopausal

Not Applicable

• Conditions: Sleep Problem
• Interventions: Behavioral: congnitive behavioural therapy

• Registration Number: NCT04719598
• Lead Sponsor: Jouf University

Brief 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 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 Timeline

• Study First Submitted: 2020-12-25
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Study Start: 2021-01-25
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-04-30
• Study Completion: 2021-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Menopaused women age between 50 and65 years
2. Able to read and write
3. Being normally ( primary ) menopause at least one year
4. Willing to give written informed consent to participate in the study.
5. Women obtaining more than 5 of the total score of the Pittsburgh Sleep Quality Index (PSQI)( that indicates poor sleep )
6. Have smartphone with internet access (WhatsApp) application

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Exclusion Criteria

1. Has serious physical disorders or uncontrolled conditions as uncontrolled blood pressure , uncontrolled blood glucose level, on hemodialysis
2. Receiving psychotropic medications, hormone replacement therapy (HRT),
3. Undergoing hysterectomy
4. Has acute or chronic surgical conditions, cancer or any other serious illness
5. Has cognitive impairments or physical handicap
6. Giving prescribed or non-prescribed medication or herbals that influencing sleep .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group is ( internet - based group) who will receive CBT sessions	congnitive behavioural therapy	study group ( group A)

Primary Outcome Measures

Name	Time	Method
change sleep quality post intervention	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	8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)	decrease insomnia index score post intervention

Secondary Outcome Measures

Name	Time	Method
change menopausal symptoms post intervention	at the end of intervention program ( 8 weeks)	decrease menopausal rating scale post intervention than pre intervention