Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT05920460
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT05920460
Study Brief:
Protocol Section:
NCT05920460