The effectiveness of Cognitive Behaviour Therapy on the quality of life and mental fatigue in women with Polycystic Ovarian Syndrome: a randomized controlled clinical trial
Objectives: To determine the effect of cognitive behavioral therapy on quality of life and mental fatigue in women with polycystic-ovarian syndrome.
Design: Two-armed randomized controlled trial.
Conduct: This study will be conducted on 74 women referring to Saqqez gynecology clinic of Imam Khomeini Hospital and private clinics of gynecology. Eligible individuals will be assessed according to the rotterdam criteria and if they have criteria, they will be referred to the research collaborator for final approval. After final diagnosis and person’s willingness to participate in the study, baseline evaluations will be conducted. Participants will be randomly assigned to two groups of intervention (receiving cognitive behavior therapy) and control using block randomization with block sizes of 4 and 6 the allocation ratio of 1:1.
Participants: Women ages 18-35 years old affected by polycystic ovarian syndrome.
Intervention: The intervention group will receive educational counseling according to Cognitive Behavior Therapy (CBT) approach in seven sessions, one session per week for seven sequential weeks. The main outcome variables include quality of life and mental fatigue and the secondary outcome variables include depression and body mass index that will be assessed before and four weeks after the end of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111410324N35
Registration date:2017-02-02, 1395/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-02, 1395/11/14
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Cognitive Behaviour Therapy on the quality of life and mental fatigue in women with Polycystic Ovarian Syndrome: a randomized controlled clinical trial
Public title
The effectiveness of Cognitive Behaviour Therapy on the quality of life and mental fatigue in women with Polycystic Ovarian Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women ages between 18 to 35 years old; Having at least secondary education; Willingness to participate in the study; Having a contact number for follow-up. Exclusion criteria: Changing of the residential location to another city in the next few months; Uncertainty of being able to participate in counseling sessions; Having cardiovascular diseases, hypertension and liver diseases; Having severe depression (according to Beck questionnaire); Taking of psychiatric or psychotropic drugs; Occurrence of unpleasant events in the last 3 months.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
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 Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.TBZMED.REC.1395.1103
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovary syndrome
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention and 4 weeks after the end of intervention
Method of measurement
Quality-of-life questionnaire (PCOSQ) for women with polycystic ovary syndrome
2
Description
Mental fatigue
Timepoint
Before intervention and 4 weeks after the end of intervention
Method of measurement
Fatigue Impact Scale (FIS)
Secondary outcomes
1
Description
Depression
Timepoint
Before intervention and 4 weeks after the end of intervention
Method of measurement
Beck Depression Inventory (BDI)
2
Description
Body Mass Index
Timepoint
Before intervention and 4 weeks after the end of intervention
Method of measurement
Balance and meter
Intervention groups
1
Description
The intervention group will receive educational counseling according to Cognitive Behavior Therapy (CBT) approach in seven sessions, one session per week for seven sequential weeks.
Category
Behavior
2
Description
The control will receive no intervention. If the results of research show the positive effect of counseling, the content of counseling as booklet will be provided for control group at the end of study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinic of Imam Khomeini Hospital
Full name of responsible person
Leila Abdollahi
Street address
Imam Khomeini Hospital, Saqqez city
City
Saqqez
2
Recruitment center
Name of recruitment center
Private clinics of gynecologists
Full name of responsible person
Liela Abdollahi
Street address
Private clinics of gynecologists, Saqqez city
City
Saqqez
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2,Tabriz Unives, Golgasht Street, Azadi A , Tabriz, East Azerbaijan
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Leila Abdollahi
Position
MSc Student of conseling in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Postal code
66156-15733
Phone
+98 41 3479 6770
Fax
Email
abdollahi.laila50.gmail. com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mojgan Mirghafourvand
Position
Associate Professor, PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
66156-15733
Phone
+98 41 3335 7582
Fax
Email
Mirghafourvandm@tbzmed.ac.ir mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Abdollahi
Position
Msc Student of counseling in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Stree
City
Tabriz
Postal code
5451796499
Phone
+98 41 4422 1874
Fax
Email
seifimah@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)