Clinical trial NCT04719598: Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Problems Among Sample of Post- Menopausal
Official title: Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Quality Among a Sample of Saudi Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Problem
Keywords: Post menopausal
intervention
sleep problems
CBT
Lead sponsor: Jouf University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one intervention group ( internet-based cognitive behavioral therapy) and one control group
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

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 .

Primary outcomes:
measure: change sleep quality post intervention
timeFrame: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
measure: change insomnia related to post menpausal symptoms post intervention
timeFrame: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
Secondary outcomes:
measure: change menopausal symptoms post intervention
timeFrame: at the end of intervention program ( 8 weeks)
Other outcomes:
Locations:
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