Back to resultsEffects of Internet - Based Cognitive Behavioral Therapy on Sleep Problems Among Sample of Post- Menopausal
Primary Purpose
Sleep Problem
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
congnitive behavioural therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Problem focused on measuring Post menopausal, intervention, sleep problems, CBT
Eligibility Criteria
Inclusion Criteria:
- Menopaused women age between 50 and65 years
- Able to read and write
- Being normally ( primary ) menopause at least one year
- Willing to give written informed consent to participate in the study.
- Women obtaining more than 5 of the total score of the Pittsburgh Sleep Quality Index (PSQI)( that indicates poor sleep )
- Have smartphone with internet access (WhatsApp) application
Exclusion Criteria:
- Has serious physical disorders or uncontrolled conditions as uncontrolled blood pressure , uncontrolled blood glucose level, on hemodialysis
- Receiving psychotropic medications, hormone replacement therapy (HRT),
- Undergoing hysterectomy
- Has acute or chronic surgical conditions, cancer or any other serious illness
- Has cognitive impairments or physical handicap
- Giving prescribed or non-prescribed medication or herbals that influencing sleep .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group is ( internet - based group) who will receive CBT sessions
control group ( group B)
Arm Description
study group ( group A)
researchers just answer their questions
Outcomes
Primary Outcome Measures
change sleep quality post intervention
improve quality of sleep than before intervention before intervention
change insomnia related to post menpausal symptoms post intervention
decrease insomnia index score post intervention
Secondary Outcome Measures
change menopausal symptoms post intervention
decrease menopausal rating scale post intervention than pre intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04719598
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jouf University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problem
Keywords
Post menopausal, intervention, sleep problems, CBT
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one intervention group ( internet-based cognitive behavioral therapy) and one control group
Masking
Participant
Masking Description
all participants will randomly assign to either an internet-based group and control group through a generated computer selection
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group is ( internet - based group) who will receive CBT sessions
Arm Type
Experimental
Arm Description
study group ( group A)
Arm Title
control group ( group B)
Arm Type
No Intervention
Arm Description
researchers just answer their questions
Intervention Type
Behavioral
Intervention Name(s)
congnitive behavioural therapy
Other Intervention Name(s)
non
Intervention Description
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.
Primary Outcome Measure Information:
Title
change sleep quality post intervention
Description
improve quality of sleep than before intervention before intervention
Time Frame
8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
Title
change insomnia related to post menpausal symptoms post intervention
Description
decrease insomnia index score post intervention
Time Frame
8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions)
Secondary Outcome Measure Information:
Title
change menopausal symptoms post intervention
Description
decrease menopausal rating scale post intervention than pre intervention
Time Frame
at the end of intervention program ( 8 weeks)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female post menpause ( 45-65 years)
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Menopaused women age between 50 and65 years
Able to read and write
Being normally ( primary ) menopause at least one year
Willing to give written informed consent to participate in the study.
Women obtaining more than 5 of the total score of the Pittsburgh Sleep Quality Index (PSQI)( that indicates poor sleep )
Have smartphone with internet access (WhatsApp) application
Exclusion Criteria:
Has serious physical disorders or uncontrolled conditions as uncontrolled blood pressure , uncontrolled blood glucose level, on hemodialysis
Receiving psychotropic medications, hormone replacement therapy (HRT),
Undergoing hysterectomy
Has acute or chronic surgical conditions, cancer or any other serious illness
Has cognitive impairments or physical handicap
Giving prescribed or non-prescribed medication or herbals that influencing sleep .
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Problems Among Sample of Post- Menopausal
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