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

Sleep Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04719598
• Other study ID #: 1384754968
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: January 2021
• Source: Jouf University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 15, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Problem
• Sleep Wake Disorders

Intervention

Behavioral:
• congnitive 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jouf University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change sleep quality post intervention	improve quality of sleep than before intervention before intervention	8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
Primary	change insomnia related to post menpausal symptoms post intervention	decrease insomnia index score post intervention	8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
Secondary	change menopausal symptoms post intervention	decrease menopausal rating scale post intervention than pre intervention	at the end of intervention program ( 8 weeks)