Effectiveness of Cognitive-Behavioral Therapy on the Quality of Life in Women with Hypothyroidism in the Reproductive Ages
Design
96 individual (48 in each group) of hypothyroid women with inclusion criteria will be visited in the Endocrine Clinic of Imam Khomeini Hospital in Ahvaz. Participants will be divided into intervention and control groups by block randomization method with block size 4.
Settings and conduct
This study is an interventional study with a control and an intervention groups. The hypothyroidism women will admitted to the Endocrinology Clinics of Ahvaz Imam Khomeini Hospital randomly assigned using block randomization with a block size of 4 and a 1: 1 ratio in the intervention and control groups. For allocation concealment the unique codes will be used and kept in the opaque envelopes by secretory of clinic. In this way, the researcher and the participant will not aware of allocation until the intervention begins.
Participants/Inclusion and exclusion criteria
Inclusion criteria are as follows: Ages between 18 to 45 years; having at least high school education; hypothyroidism diagnosed by an Endocrinologist; consent to participate in the study; under medication with levothyroxine; scores less than 50 from SF-36 Quality of Life Questionnaire. Exclusion criteria are as follows: pregnancy; thyroid malignancy; known mental illness (dementia-depression); chronic and high-risk diseases such as cancer, multiple sclerosis, pulmonary and renal disease, congestive heart failure, smoking, alcohol or drug abuse and under medication with psychotropic and neuropsychiatric drugs; The occurrence of abnormal stress due to the life-threatening events such as death of a spouse or a family member in the past six months.
Intervention groups
The intervention group received 8 sessions of Cognitive-behavioral Therapy, and no treatment for control group
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190323043101N1
Registration date:2019-08-12, 1398/05/21
Registration timing:registered_while_recruiting
Last update:2019-08-12, 1398/05/21
Update count:0
Registration date
2019-08-12, 1398/05/21
Registrant information
Name
Soheila Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3446 1523
Email address
rezaei.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive- Behavioral Therapy on Quality of Life in Women with Hypothyroidism in Reproductive Ages
Public title
Effectiveness of Cognitive-Behavioral Therapy on Quality of Life in Women with Hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 to 45 years
Diagnose of Hypothyroidism by Endocrinologist
Conscious consent to participate in the study
Under medication with levothyroxine
Scores less than 50 from SF-36 Quality of Life Questionnaire
At least high school education
Exclusion criteria:
Pregnancy
Diagnosis of malignancy in thyroid
Known mental illness (dementia-depression)
Chronic and high-risk diseases such as cancer-multiple sclerosis-pulmonary and renal disease-congestive heart failure
Smoking, Alcohol or drug abuse and under medication with Psychotropic and Neuropsychiatric drugs
The occurrence of abnormal stress due to life-threatening events such as the death of a spouse or a family member in the past six months
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning intervention to patients is randomly using block randomization with block size of 4 and a ratio of 1: 1. For allocation concealment, the unique codes in the opaque envelopes will be used. The envelopes will be remained with the secretory of the clinic until the time of intervention. In this way, the researcher and the participant will not aware of allocation until the intervention begins. All patients will be screened regarding the inclusion criteria and eligible patients will be randomized into one of the intervention and control groups base on the randomization list.
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 and Health Services
Street address
Ahvaz Jundishapur University of Medical Scie nces and Health Services, Golestan Blvd, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.AJUMS.REC.1397.968
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E01;E02;E0
ICD-10 code description
Iodine-deficiency related thyroid disorders and allied conditions; subclinical iodine-deficiency hypothyroidism; Other hypothyroidism
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
Ware & Sherbourne Quality of Life Questionnaire (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the intervention group will received 8 sessions of cognitive-behavioral therapy about the psychological complications of Hypothyroidism such as sadness and depression by the researcher. The treatment will be included an explanation of the cognitive behavioral therapy model, cognitive reconstruction, self-control and mood enhancement activities, muscle relaxation exercises, imagination, positive self-esteem, diaphragmatic breathing, meditation, introducing effective coping steps. There will be one session (90 minutes) each week. After completion of the sessions post-test will be taken.
Category
Behavior
2
Description
Control group: No treatment for control group.The post test will be taken from the control group.
Ahvaz Jundishapur University of Medical Scienc ealth Services, Golestan BLVD, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Fax
+98 61 3373 8333
Email
info@ajums.ac.ir
Grant name
Grant of faculty members
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Soheila Rezaei
Position
Ms.c Student in Midwifery Consultant
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Jundishapur University of Medical Science a nd Health Services, Golestan BLVD, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Fax
+98 61 3373 8333
Email
rezaei.s@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soheila Rezaei
Position
Ms.c Student in consultant Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Jundishapur University of Medical Science and Health Services, Golestan BLVD, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Fax
+98 61 3373 8333
Email
rezaei.s@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soheila Rezaei
Position
Ms.c Student in consultant Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Jundishapur University of Medical Science ,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Fax
+98 61 3373 8333
Email
rezaei.s@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After unrecognizable the participants, the information of original outcome will be shared.
When the data will become available and for how long
The publication of the information will be possible six months after the publication of the results.
To whom data/document is available
Access to research documentation for research centers and researchers and therapists is possible.
Under which criteria data/document could be used
Approve Ahvaz University of Medical Sciences, Appropriateness of Information Required with Health Promotion Programs
From where data/document is obtainable
Ahvaz University of Medical Sciences, Vice-Chancellor of Research and Technology, Dr. Mohammad Badvi, Postal code 61357-15794 Phone 0098613311 Email info@ajums.ac.ir
What processes are involved for a request to access data/document
Following the correspondence with the research deputy of Ahvaz University of Medical Sciences, the results will be available to the applicants.