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

NCT04719598 | Unknown DMC

• 1 other identifier: 1384754968
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Problem

Keywords

Post menopausal; intervention; sleep problems; CBT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• change menopausal symptoms post intervention

  at the end of intervention program ( 8 weeks)

Study Arms (2)

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

EXPERIMENTAL

study group ( group A)

Behavioral: congnitive behavioural therapy

control group ( group B)

NO INTERVENTION

researchers just answer their questions

Interventions

congnitive behavioural therapy 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.

Also known as: non

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

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: female post menpause ( 45-65 years)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Jouf University: lead

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: all participants will randomly assign to either an internet-based group and control group through a generated computer selection
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

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

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: January 22, 2021
• Study Start: January 25, 2021
• Primary Completion: April 30, 2021
• Study Completion: June 15, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share