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

• ClinicalTrials.gov Identifier: NCT04719598
• Recruitment Status: Not yet recruiting
• First Posted: January 22, 2021
• Last Update Posted: February 2, 2021
• Sponsor: Jouf University
• Information provided by (Responsible Party): Enas Mahrous AbdelAziz, Jouf University

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.

Condition or disease	Intervention/treatment	Phase
Sleep Problem	Behavioral: congnitive behavioural therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: one intervention group ( internet-based cognitive behavioral therapy) and one control group
• Masking: Single (Participant)
• Masking Description: all participants will randomly assign to either an internet-based group and control group through a generated computer selection
• Primary Purpose: Supportive Care
• Official Title: Effects of Internet - Based Cognitive Behavioral Therapy on Sleep Quality Among a Sample of Saudi Postmenopausal Women
• Estimated Study Start Date: January 25, 2021
• Estimated Primary Completion Date: April 30, 2021
• Estimated Study Completion Date: June 15, 2021

Arms and Interventions

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 Name: non
No Intervention: control group ( group B); researchers just answer their questions

Outcome Measures

Primary Outcome Measures :

1. change sleep quality post intervention [ Time Frame: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions) ]
   improve quality of sleep than before intervention before intervention
2. change insomnia related to post menpausal symptoms post intervention [ Time Frame: 8 weeks (two weeks ( introductory sessions ) pluse six weeks ( intervention sessions) ]
   decrease insomnia index score post intervention

Secondary Outcome Measures :

1. change menopausal symptoms post intervention [ Time Frame: at the end of intervention program ( 8 weeks) ]
   decrease menopausal rating scale post intervention than pre intervention

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: female post menpause ( 45-65 years)
• Accepts Healthy Volunteers: No

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 .

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Enas Mahrous AbdelAziz, Assistant professor, Jouf University
• ClinicalTrials.gov Identifier: NCT04719598
• Other Study ID Numbers: 1384754968
• First Posted: January 22, 2021
• Last Update Posted: February 2, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enas Mahrous AbdelAziz, Jouf University:

Post menopausal; intervention; sleep problems; CBT

Additional relevant MeSH terms:

Dyssomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations