Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women

NCT ID: NCT05920460

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2022-09-29

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.

Conditions

Depression; Insomnia; Cognitive Behavioral Therapy; Menopausal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

The Cognitive Behavioral Therapy group received seven weekly face-to-face sleep group Cognitive Behavioral Therapy sessions lasting for 50-60 min. The Cognitive Behavioral Therapy program was developed by the research team after reviewing the literature and consulting with experts. Cognitive Behavioral Therapy was held in a lecture hall located in the PPFK branch office before individual counseling was initiated.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy Program

Intervention Type: 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

Control Group

The study participants of the control arm were interviewed separately and were given general health advice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Loutfy, Ph.D.

Lecturer of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-Suef University

Banī Suwayf, Other, Egypt

Mansoura University

Al Mansurah, , Egypt

Countries

Egypt

References

El-Monshed AH, Khonji LM, Altheeb M, Saad MTE, Elsheikh MA, Loutfy A, Ali AS, El-Gazar HE, Fayed SM, Zoromba MA. Does a program-based cognitive behavioral therapy affect insomnia and depression in menopausal women? A randomized controlled trial. Worldviews Evid Based Nurs. 2024 Apr;21(2):202-215. doi: 10.1111/wvn.12707. Epub 2024 Feb 8.

Reference Type: DERIVED

PMID: 38329153 (View on PubMed)

Other Identifiers

Hashem2023

Identifier Type: -

Identifier Source: org_study_id