DepressionNCT05920460
Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women
A study testing Cognitive Behavioral Therapy Program in people with Depression and Insomnia, run by Beni-Suef University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Insomnia, Cognitive Behavioral Therapy
- What is being tested?
- Cognitive Behavioral Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jun 2022to 29 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mansoura University
Al Mansurah
Beni-Suef University
Banī Suwayf, Other, 62511
About this study
Official title: Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women: A Randomized Control Trial
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.
- Being tested
- Cognitive Behavioral Therapy Program
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 - 12 weeks
Secondary outcomes (1)
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.
Measured: 8 - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start15 Jun 2022
- Primary completion30 Aug 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Loutfy, Ph.D., Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920460
- Sponsor's protocol ID
- Hashem2023
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38329153
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia and Depression Among Menopausal Women: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05920460
- Acronym / sponsor ID
- Hashem2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Cognitive Behavioral Therapy ProgramThe 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. |
| Control Group | No intervention | –The study participants of the control arm were interviewed separately and were given general health advice. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy ProgramBrief 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 | Behavioural | Experimental Group |
Primary outcome
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.
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.
1 secondary outcome
Correlation between studied variables before application of the intervention
Time frame: 8 - 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 38329153El-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy Program in people with Depression and Insomnia, run by Beni-Suef University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Cognitive Behavioral Therapy on Womens' insomnia symptom (time frame: 8 - 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.