]>
IRCT20190323043101N1 IRCT 2019-08-12 Ahvaz University of Medical Sciences Effectiveness of Cognitive-Behavioral Therapy on Quality of Life in Women with Hypothyroidism Effectiveness of Cognitive- Behavioral Therapy on Quality of Life in Women with Hypothyroidism in Reproductive Ages 2019-08-11 anticipated 96 Complete https://irct.ir/trial/38491 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Hypothyroidism. Intervention 1: 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. Intervention 2: Control group: No treatment for control group.The post test will be taken from the control group. Yes - There is a plan to make this available What will be shared: After unrecognizable the participants, the information of original outcome will be shared. When: The publication of the information will be possible six months after the publication of the results. To whom: Access to research documentation for research centers and researchers and therapists is possible. Conditions: Approve Ahvaz University of Medical Sciences, Appropriateness of Information Required with Health Promotion Programs Where to obtain: 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 How to obtain: Following the correspondence with the research deputy of Ahvaz University of Medical Sciences, the results will be available to the applicants. Comments:
public Soheila Rezaei
Ahvaz, Jundishapur University of Medical Science a nd Health Services, Golestan BLVD, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8395 rezaei.s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Soheila Rezaei
Ahvaz, Jundishapur University of Medical Science and Health Services, Golestan BLVD, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8395 rezaei.s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Female 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 E01;E02;E0 Iodine-deficiency related thyroid disorders and allied conditions; subclinical iodine-deficiency hypothyroidism; Other hypothyroidism Behavior N/A 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. Control group: No treatment for control group.The post test will be taken from the control group. 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). Ahvaz University of Medical Sciences Approved 2019-03-16 Ethics committee of Ahvaz Jundishapur University of Medical Sciences and Health Services Ahvaz Jundishapur University of Medical Scie nces and Health Services, Golestan Blvd, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)