Comparing Face-to-Face and Telephone-Based CBT on Postmenopausal Hot Flushes
Design
This is a randomized clinical trial with two intervention groups of 20 people, community based and pragmatic, with parallel groups and there is no blindness
Settings and conduct
This research will be conducted in the menopausal clinic of Imam Hospital. Our subjects will be selected among eligible registered documents and then women will be invited to participate in this study via phone call .
Participants/Inclusion and exclusion criteria
Inclusion criteria:normal menopause; passing at least one year and maximum five years from the cessation of menstruation; being able to read and write; having at least 10 hot flashes per week in a duration of one month; having a score of more than 1 in response to the kupperman index; having a cell phone. Non-entry criteria: known mental and physical illnesses; history of CBT; drug and other psychotropic substances abuse; under medication for hot flashes
Intervention groups
There will be held six sessions of 30 minutes cognitive-behavioral counseling on a weekly basis for each group.These sessions composed of: providing information about physiology of menopause; introducing cognitive behavioral model (including physiological, cognitive, behavioral and emotional components for hot flashes),teaching breath and relaxation techniques, emphasize the role of stress in boosting hot flashes and cognitive behavioral strategies for reducing it, focus on cognitive responses(Tragedy thoughts and extreme negative beliefs about hot flushes) and behavioral reactions(avoidance and activity) on hot flushes, providing weekly assignments, implementing cognitive behavioral strategies for hot flushes management and breathing techniques and finally, preparing the main list of beliefs, their variability and methods for changing negative beliefs.
Main outcome variables
Hot flushes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180918041065N1
Registration date:2018-11-20, 1397/08/29
Registration timing:retrospective
Last update:2018-11-20, 1397/08/29
Update count:0
Registration date
2018-11-20, 1397/08/29
Registrant information
Name
Nasim Sadeghijoola
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3552 2957
Email address
nasim.sadeghijoola@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Face-to-Face and Telephone-Based Cognitive Behavioral Therapy on Hot Flushes in Postmenopausal Women
Public title
Cognitive-Behavioral Therapy (CBT) on hot flushes in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal Menopause
Passing at least one year and maximum five years from the cessation of menstruation
Being able to read and write
Having at least 10 hot flashes per week in a duration of one month
Having a score of more than 1 in response to the kupperman index
Having a cell phone
Exclusion criteria:
Known Mental and Physical illnesses
History of Cognitive Behavioral Therapy(CBT)
Drug and other psychotropic substances abuse
Under medication for hot flashes
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, eligible individuals will be randomly assigned to two groups of
telephone counseling (N=20) and face-to-face counseling (N=20) using block randomization (block size: 4 and allocation ratio: 1). For allocation concealment, 20 four digit numbers will be selected for each participant in the telephone group and face-to face group respectively and will be arranged according to the block size. Then in order to hide the allocation, the numbers will be arranged in blocks of opaque envelop, respectively and will be given randomly to eligible individuals by the secretary.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Iran, Ahvaz, Golestan Blv, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.AJUMS.REC.1397.289
Health conditions studied
1
Description of health condition studied
Hot flushes in Postmenopausal women
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Hot flush score in the Kupperman index
Timepoint
Hot flush at baseline, at the end of intervention, six weeks after intervention, and two months after intervention
Method of measurement
Kupperman Index
Secondary outcomes
empty
Intervention groups
1
Description
ّFor the face-to face group, six sessions of 30 minutes each of cognitive-behavioral counseling will be held on a weekly basis for one intervention groups. These sessions composed of the following issues: expression of the rules and objectives of the study, providing information about physiology of menopause as well its complications and treatment, introducing cognitive behavioral model including physiological, cognitive,behavioral and emotional components for hot flashes and night sweats, teaching breath and relaxation techniques, emphasizing the role of stress in boosting hot flashes, night sweats and cognitive behavioral strategies for reducing it, focusing on cognitive responses(tragedy thoughts and extreme negative beliefs about hot flushes) and behavioral reactions(avoidance and activity) on hot flushes, providing weekly assignments, implementing cognitive behavioral strategies for hot flushes management, breathing techniques and relaxation for home work and finally preparing the main list of beliefs and cognition as well as their variability and methods to change negative beliefs.
Category
Treatment - Other
2
Description
For the telephone based counseling, there will be six sessions of 20-30 minutes telephone cognitive-behavioral counseling on a weekly basis. The content of these sessions are as follows: expression of the rules and objectives of the study, providing information on physiology of menopause as well as its complications and treatment, introducing cognitive behavioral model including physiological, cognitive,behavioral and emotional components for hot flashes and night sweats, teaching breath and relaxation techniques, emphasizing the role of stress in boosting hot flashes, night sweats and cognitive behavioral strategies for reducing it, focusing on cognitive responses(tragedy thoughts and extreme negative beliefs about hot flushes) and behavioral reactions(avoidance and activity) on hot flushes, providing weekly assignments, implementing cognitive behavioral strategies for hot flushes management, breathing techniques and relaxation for home work and finally preparing the main list of beliefs and cognition as well as their variability and methods to change negative beliefs.