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Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women

Primary Purpose

Depression, Insomnia, Cognitive Behavioral Therapy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy Program
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beni-Suef University
  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Correlation between studied variables before application of the intervention
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.

Full Information

First Posted
April 19, 2023
Last Updated
June 17, 2023
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05920460
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Insomnia, Cognitive Behavioral Therapy, Menopausal Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The study participants of the control arm were interviewed separately and were given general health advice.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy Program
Intervention Description
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 Outcome Measure Information:
Title
The effect of Cognitive Behavioral Therapy on Womens' insomnia symptom
Description
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.
Time Frame
8 - 12 weeks
Title
The effect of Cognitive Behavioral Therapy on Womens' depressive levels
Description
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.
Time Frame
8 - 12 weeks
Secondary Outcome Measure Information:
Title
Correlation between studied variables before application of the intervention
Description
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.
Time Frame
8 - 12 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
The main aim focused on women at age of menopause.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Beni-Suef University
City
Banī Suwayf
State/Province
Other
ZIP/Postal Code
62511
Country
Egypt
Facility Name
Mansoura University
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

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Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women

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