Clinical trial NCT05920460: Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women
Official title: Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Insomnia
Cognitive Behavioral Therapy
Menopausal Depression
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The effect of Cognitive Behavioral Therapy on Womens' insomnia symptom
timeFrame: 8 - 12 weeks
measure: The effect of Cognitive Behavioral Therapy on Womens' depressive levels
timeFrame: 8 - 12 weeks
Secondary outcomes:
measure: Correlation between studied variables before application of the intervention
timeFrame: 8 - 12 weeks
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University
state: Other
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References: