The assessment of effect of cognitive-behavioral counseling on stress , anxiety and depression in menopausal women : A Randomized Controlled Clinical Trial
-The aim of this study is to determine the effect of cognitive-behavioral counseling on stress, anxiety and depression in post-menopausal women. This study is a Randomized, Controlled Clinical Trial. Participants included 90 postmenopausal women who referred to health centers in Tuiserkan city and elected by available sampling method. In this study for implement the random allocation method simple random will be used. This means that 90 consecutive numbers written on paper separately and placed inside a container. Elected even numbers to the group A (control) and elected odd numbers to the group B (intervention) Will be entered. This study was a single blinded, and blinding performance only for data analyst will be implemented. The inclusion criteria: Having a natural menopause (not due to drugs or surgery), age 47 to 57 years with at least 1 and a maximum of 4 years since the last normal menstrual and no chronic disease or acute that limits their participation in the study and exclusion criteria are: Not participating in two or more sessions of counseling and the use of hormone therapy during the study. After random distribution of two groups the measures, including stress, anxiety and depression in both groups by DASS-21 questionnaire carried out. For the control group in addition to routine clinic care, after completing the assessments, a training plan will be held. For the intervention group, counseling process in the form of groups of 12-11 people with cognitive-behavioral approach, during a six- one hour meeting In the conference hall of Tuiserkan city health center will be held .
After the intervention, and a month later measures will be repeated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081624753N2
Registration date:2016-09-03, 1395/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-03, 1395/06/13
Registrant information
Name
Mitra Kolivand
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 9980
Email address
mitrakolivand@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Public budget: Kermanshah University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of effect of cognitive-behavioral counseling on stress , anxiety and depression in menopausal women : A Randomized Controlled Clinical Trial
Public title
The assessment of the effect of cognitive-behavioral counseling on stress , anxiety and depression in menopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria include: Having a natural menopause (not due to drugs or surgery); The age of 47 to 57 years; Minimum 1 and maximum 4 years of their last normal menstrual have passed; Without any chronic or acute disease in the past 12 months with an intensity that person could not attend meetings; Not using hormone therapy to reduce menopausal symptoms;
Exclusion criteria include: Not participating in two or more sessions of counseling; The use of hormone therapy during the study
Age
From 47 years old to 57 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No. 2 of Kermanshah University of Medical Sciences, Shaheid Beheshti Blvd. Kermanshah.
City
Kermanshah
Postal code
6714673159
Approval date
2016-07-23, 1395/05/02
Ethics committee reference number
IR.KUMS.REC.1395.327
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
3
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, after the intervention, and a month later
Method of measurement
DASS-21 questionnaire
2
Description
Stress
Timepoint
Before the intervention, after the intervention, and a month later
Method of measurement
DASS-21 questionnaire
3
Description
Depression
Timepoint
Before the intervention, after the intervention, and a month later
Method of measurement
DASS-21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: In the intervention group 6 one-hour cognitive-behavioral counseling session during 6 weeks will be held.
Category
Lifestyle
2
Description
Intervention 2: In the control group, after the end of the assessments, a one-hour training session will be held.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Clinic
Full name of responsible person
Marzie Soori
Street address
17 Shahrivar Clinic, Enghelab Ave.Tuiserkan
City
Tuiserkan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzehee
Street address
Building No. 2 of Kermanshah University of Medical Sciences, Shaheid Beheshti Blvd. Kermanshah
City
Kermabshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Marzie Soori
Position
Master Student of Counselling in Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3827 9899
Fax
Email
mrs.marziesoori@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Kolivand
Position
Student of Reproductive Health-PHD Degree-Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3827 9899
Fax
Email
mitrakolivand@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Marzie Soori
Position
Master Student of Counselling in Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3827 9899
Fax
Email
mrs.marziesoori@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)