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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Problem
• Intervention / Treatment: Behavioral: congnitive behavioural therapy

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group is ( internet - based group) who will receive CBT sessions; study group ( group A)	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.; Other Names: non
No Intervention: control group ( group B); researchers just answer their questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change menopausal symptoms post intervention	decrease menopausal rating scale post intervention than pre intervention	at the end of intervention program ( 8 weeks)

Collaborators and Investigators

• Sponsor: Jouf University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2021
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): June 15, 2021

Study Registration Dates

• First Submitted: December 25, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: intervention; CBT; sleep problems; Post menopausal
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 1384754968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No