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

Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Quality Among a Sample of Saudi Postmenopausal Women

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04719598
Enrollment
80
Registered
2021-01-22
Start date
2021-01-25
Completion date
2021-06-15
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Problem

Keywords

Post menopausal, intervention, sleep problems, CBT

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

Interventions

BEHAVIORALcongnitive behavioural therapy

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.

Sponsors

Jouf University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

all participants will randomly assign to either an internet-based group and control group through a generated computer selection

Intervention model description

one intervention group ( internet-based cognitive behavioral therapy) and one control group

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
change sleep quality post intervention8 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 intervention8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)decrease insomnia index score post intervention

Secondary

MeasureTime frameDescription
change menopausal symptoms post interventionat the end of intervention program ( 8 weeks)decrease menopausal rating scale post intervention than pre intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026