Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women

Depression Clinical Trial

Official title:

Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05920460
• Other study ID #: Hashem2023
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: September 29, 2022

Study information

• Verified date: June 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Considering physical and psychological problems that threaten women during the menopausal period, it seems that therapies that can help women cope with these problems, especially psychological ones, will be useful. The community mental health nurse is usually the first health professional whom women rely on to relieve their menopause symptoms. It is essential for the primary health care nurse to know how to properly approach women at this stage of their life and how to provide them the best and safe treatment. Because only limited interventional studies have been done to manage insomnia and depression among menopausal women in Egypt, the present study focused on reducing and insomnia and depression of menopausal women by using group Cognitive behavioral therapy. The current study aimed to examine the efficiency of group Cognitive Behavioral Therapy for insomnia and depression among menopausal women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 29, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women with depression (BDI-II score of 14-63)
• Women aged between 40 and 55 years old, menopausal (12 consecutive months without menses)
• Women are willing to provide written informed consent to participate in the study.
• Women who have the ability to read and write Arabic language.
• Women who report wake after sleep onset (wakefulness in the middle of the night after falling asleep) of an hour or more on = 3 nights per week and met criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association, 2013) insomnia disorder with onset or exacerbation during the peri- or postmenopausal period per clinical interview with the researcher.
• Women who have a total score of >5 on the Pittsburgh Sleep Quality Index (PSQI), which indicates poor sleep, and a total score of >7 on the Insomnia Severity Index (ISI), which indicates insomnia.

Exclusion Criteria:

• Women who are currently under any type of psychotherapy or have a previous experience of Cognitive Behavioral Therapy.
• Women who have a history of neuropsychiatric illness, cancer, chemotherapy, and sudden stress in the previous 6 months (due to unfortunate events in the family) or have a severe or uncontrolled physical illness.
• Women who are clearly diagnosed as having sleep disorders or obstructive sleep apnea and had taken sleeping medications.
• Women who are on hormonal replacement therapy or cancer therapy or drugs such as tricyclic antidepressants, selective serotonin reuptake inhibitors, sedatives, and other hormones; and those who had undergone hysterectomy with oophorectomy.

Related Conditions & MeSH terms

• Cognitive Behavioral Therapy
• Depression
• Depressive Disorder
• Insomnia
• Menopausal Depression
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy Program
Brief description of the Cognitive Behavioral Therapy program is given below: Session 1: Mutual understanding and rapprochement Session 2: Sleep hygiene education Session 3: Psychoeducation about stimulus control strategies; monitoring sleep environments, and identification of behavioral habits at bedtime, dysfunctional beliefs, and attitudes about sleep. Session 4: Training on relaxation techniques Session 5: Psycho education about depression Session 6: Cognitive restructuring Session 7: The terminating session

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Bani Suwayf	Other
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Cognitive Behavioral Therapy on Womens' insomnia symptom	the women who received the Cognitive Behavioral Therapy would exhibit a significantly change in insomnia symptom after the program compared to women in the control group.; The Insomnia Severity Index (ISI; Morin et al., 2011), the ISI aims to assess the severity of insomnia over the past 2 weeks.	8 - 12 weeks
Primary	The effect of Cognitive Behavioral Therapy on Womens' depressive levels	the women who received the Cognitive Behavioral Therapy would exhibit a significantly change in depressive levels after the program compared to women in the control group.; The Beck Depression Inventory, 2nd edition (BDI-II; Beck et al., 1996), BDI-II aims to assess the depressive symptoms. It is a 21-item self-report statements about how the person had been feeling in the last week. The BDI-II scores range from 0 to 63, with higher scores indicating greater severity.	8 - 12 weeks
Secondary	Correlation between studied variables before application of the intervention	Sleep quality index investigates the correlation significantly to insomnia severity index and beck depression inventory.; The Pittsburgh Sleep Quality Index (PSQI) 1989, the PSQI is a self-completed questionnaire that assesses sleep quality over the previous month. The scale has 19-items, five of which should be answered by bed mates or roommates.	8 - 12 weeks