Comparing the effectiveness of virtual cognitive behavioral counseling with face-to-face cognitive behavioral counseling on sleep disorders of menopausal women
Comparing the effectiveness of virtual cognitive behavioral counseling with face-to-face cognitive behavioral counseling on sleep disorders of menopausal women
Design
Clinical trial with control group, with randomized parallel groups without blinding on 63 postmenopausal women. Blocks of four and two-by-two allocation are used for randomization using computer software.
Settings and conduct
The people who are eligible to participate in the study based on the relevant questionnaires will be randomly divided into three groups of 21 people: face-to-face counseling, virtual counseling and a control group in Ahvaz city . The intervention includes face-to-face and virtual cognitive-behavioral counseling for two intervention groups, and the control group will receive an educational pamphlet.
Participants/Inclusion and exclusion criteria
Menopausal women who are at least one year and at most five years past their menopause and are 45-60 years old and have the characteristics of the research samples based on the questionnaires intended to diagnose sleep problems. Suffering from severe anxiety and depression and taking antipsychotic drugs are the main conditions of non-entry.
Intervention groups
For the people of the virtual cognitive behavioral counseling group and the people of the face-to-face cognitive-behavioral counseling group, 8 sessions of cognitive-behavioral therapy will be held in virtual and face-to-face respectively. For the control group, routine care of Ahvaz health centers will be provided along with educational pamphlets.
Main outcome variables
Improvement of Pittsburgh Sleep Disorder and Sleep Quality Index score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240930063215N1
Registration date:2024-10-02, 1403/07/11
Registration timing:prospective
Last update:2024-10-02, 1403/07/11
Update count:0
Registration date
2024-10-02, 1403/07/11
Registrant information
Name
Fatemeh Ajloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 432 5825
Email address
maedeh.ajloo1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-21, 1403/07/30
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of virtual cognitive behavioral counseling with face-to-face cognitive behavioral counseling on sleep disorders of menopausal women
Public title
The effect of face-to-face and virtual cognitive-behavioral counseling on sleep disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45 and 60 years
Passing at least one year and at most 5 years from menopause
Being married
Reading and writing literacy at the minimum level
Diagnosis of sleep disorder based on insomnia severity index questionnaires and Pittsburgh sleep quality questionnaire
Willingness to participate in the project
Having written consent
Exclusion criteria:
Having a medical illness that interferes with sleep problems
working in a night shift job
recent participation in psychotherapy programs or cognitive behavioral therapy for other problems
recent severe trauma during the past three months
taking an unstable amount of sleeping pills and taking antipsychotic drugs
getting sick mental disorders including severe depression and severe anxiety, which lead to sleep problems
use of tobacco (more than 10 cigarettes per day) and drugs and alcohol
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were first through clustering and referring to the existing files and through phone calls or after visiting the clinics in person, using computer software into three groups of 21 people, face-to-face cognitive behavioral counseling, virtual cognitive behavioral counseling And the control group will be divided. The codes assigned to each participant are written on a piece of paper and kept by the secretary of the center. Therefore, before the start of the intervention, the researchers and the participants do not know about the grouping of the participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A clinical trial with a control group, randomized, with allocation to groups in blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan area
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-09-29, 1403/07/08
Ethics committee reference number
IR.AJUMS.REC.1403.326
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Improving indicators of sleep disorders
Timepoint
Before the start of the intervention , 4 weeks after the start of the intervention, one week and one month after the end of the intervention
Method of measurement
Insomnia Severity Index Questionnaire, Pittsburgh Sleep Quality Index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the face-to-face counseling group, 8 cognitive-behavioral counseling sessions will be held in person and for the virtual counseling group, 8 cognitive-behavioral counseling sessions will be held virtually. The control group will receive the usual care along with the educational booklet. In order to evaluate the results of the treatment, relevant questionnaires will be completed by the participants before the intervention, four weeks after the intervention, one week and one month after the end of the intervention and will be used for statistical analysis.