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

NCT ID: NCT04719598

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2021-06-15

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

Conditions

Sleep Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention group is ( internet - based group) who will receive CBT sessions

study group ( group A)

Group Type: EXPERIMENTAL

congnitive behavioural therapy

Intervention Type: BEHAVIORAL

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.

control group ( group B)

researchers just answer their questions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

non

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 .

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jouf University

OTHER

Sponsor Role: lead

Responsible Party

Enas Mahrous AbdelAziz

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1384754968

Identifier Type: -

Identifier Source: org_study_id