Determining the effect of cognitive-behavioral counseling on depression and anxiety in women with polycystic ovaries
Design
A randomized controlled clinical trial with two parallel arms.The final sample size was 42 people in each group
Settings and conduct
This study will be performed on 42 women with approved polycystic ovary syndrome in Al-Zahra Educational and Medical Centers in Tabriz. Participants will be assigned to the intervention and control groups using a random blocking method with the size of 4 and 6 blocks with a 1: 1 allocation ratio.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Minimum secondary education, 2- Diagnosis of polycystic ovary syndrome by a gynecologist and having a medical record due to polycystic ovary syndrome Exclusion criteria: 1- Having a history of mental illness according to the person 2 Having a history of chronic physical illnesses (heart disease, hypertension, lung disease, iron deficiency anemia, diabetes, thyroid disease, epilepsy) according to the person's experience 3- Experiencing a severe mental crisis during the last 3 months Such as the death of relatives according to the self-declaration 4- Pregnant and childbirth women 5- Women with severe depression
Intervention groups
For the intervention group, group counseling with a cognitive-behavioral approach will be held in 8 sessions of 45 to 60 minutes, once a week. An educational booklet is provided for the control group.
Main outcome variables
Average score of anxiety and depressionAverage score of anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110826007418N7
Registration date:2021-10-25, 1400/08/03
Registration timing:registered_while_recruiting
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
Parisa Yavarikia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
yavarikiap@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral counseling on depression and anxiety in women with polycystic ovary syndrome: a randomized controlled trial
Public title
The effect of cognitive-behavioral counseling on depression and anxiety in women with polycystic ovary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovary syndrome, based on information recorded in the patient's file
A score of 35-65 in the Spielberger Anxiety Questionnaire and a score above 20 in depression
Minimum secondary education
Exclusion criteria:
Having a history of mental illness according to the individual
Having a history of chronic physical diseases (heart disease, hypertension, lung diseases, iron deficiency anemia, diabetes, thyroid diseases, epilepsy) according to the individua
According to the individual Experiencing a severe psychological crisis during the last 3 months,such as the death of relatives
Pregnant and postpartum women
Women with severe depression
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to two intervention groups (receiving cognitive-behavioral counseling) and the control group by random blocking method with 4 and 6 block sizes and 1: 1 allocation ratio. To hide the type of intervention, it will be written on a piece of paper and numbered in a matte envelope. The envelopes will be opened in the order in which the participants enter the study and the type of group will be determined. Random allocation and preparation of envelopes will be done by a person not involved in sampling and data
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 Tabriz University of Medical Sciences
Street address
South Shariati St. - School of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.TBZMED.REC.1400.229
Health conditions studied
1
Description of health condition studied
ََAnxiety in women with polycystic ovary syndrome
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
ِDepression in women with polycystic ovary syndrome
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Depression
Timepoint
Before and after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
Spielberger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Intervention group: 8 sessions of counseling with cognitive-behavioral approach for 45-60 minutes once a week in a calm environment and in groups (5 to 7 people in each group) will be held. The content of these sessions includes initial psychological assessment, rearrangement of concepts, use of clinical skills, strengthening of skills and how to use them, generalization and maintenance, follow-up and evaluation after the intervention.
Category
Behavior
2
Description
Control group: Participants in the control group will receive routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Educational and Medical Center
Full name of responsible person
Sheida Majidzadeh
Street address
South Shariati St., School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
Smajidzadeh30@Gmail.com
2
Recruitment center
Name of recruitment center
Comprehensive Health Centers of Tabriz
Full name of responsible person
Seida Majidzadeh
Street address
South Shariati St., School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
Smajidzadeh30@Gmail.com
3
Recruitment center
Name of recruitment center
Private Offices in Tabriz
Full name of responsible person
Seida Majidzadeh
Street address
South Shariati St., School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
Smajidzadeh30@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, Research Deputy
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavari Kia
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Fax
Email
p_k_hn@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavari Kia
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Fax
+98 41 3177 2048
Email
p_k_hn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavari Kia
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Fax
+98 41 3177 2048
Email
p_k_hn@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available