Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women

NCT05920460 | Completed

• 1 other identifier: Hashem2023
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Correlation between studied variables before application of the intervention

  8 - 12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy Program

Control Group

NO INTERVENTION

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

Interventions

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

Experimental Group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: The main aim focused on women at age of menopause.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Beni-Suef University

Banī Suwayf, Other, 62511, Egypt

Location

Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 38329153 DERIVED

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Nursing

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: June 27, 2023
• Study Start: June 15, 2022
• Primary Completion: August 30, 2022
• Study Completion: September 29, 2022
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

EG (2)