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Completed

NCT Number: NCT05920460

Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women

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.

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Key information

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University, Banī Suwayf, Other, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy Program

Behavioral

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

Primary outcomes

  1. The effect of Cognitive Behavioral Therapy on Womens' insomnia symptom

    Time frame: 8 - 12 weeks

    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.

  2. The effect of Cognitive Behavioral Therapy on Womens' depressive levels

    Time frame: 8 - 12 weeks

    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.

Secondary outcomes

  1. Correlation between studied variables before application of the intervention

    Time frame: 8 - 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2023
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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