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IRCT20120718010324N64 IRCT 2021-02-14 Tabriz University of Medical Sciences The Effect of Cognitive-Behavioral Therapy on Stress and Anxiety The Effect of Cognitive-Behavioral Therapy on Stress and Anxiety of Women with Premature Ovarian Insufficiency: A Randomized Controlled Trial 2021-02-17 anticipated 48 Complete https://irct.ir/trial/52024 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be assigned to the two groups including Intervention group (Recipient of cognitive-behavioral counseling) and control group by the block randomization method with block sizes of 4 and 6 and with a 1: 1 allocation ratio. In order to hide the allocation (Allocation Concealment), the type of intervention is written on paper and sealed in opaque envelopes. The envelopes will be opened based on the order of the participants entering to 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 collection. N/A Condition 1: Stress. Condition 2: Anxiety. Intervention 1: Intervention group: 8 sessions of counseling with cognitive-behavioral approach will be held for 45-60 minutes once a week in a calm environment and in groups (5 to 7 people in each group). The content of these sessions includes initial psychological assessment, reorganization of concepts, use of clinical skills, strengthening skills and how to use them, generalization and maintenance, follow-up and evaluation after intervention. Intervention 2: Control group: Participants in the control group will receive routine care. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential.
public Fatemeh Shabani
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3177 2048 fatemehshabani7697@gmail.com Tabriz University of Medical Sciences scientific Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3177 2048 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age under 40 years Confirmation of premature ovarian failure with necessary tests Moderate Anxiety Based on Spielberger Index Moderate stress based on perceived stress index Listening and speaking ability 15 years 40 years Female History of a specific mental illness Previous participation in sessions related to premature menopause Mental and motor disability Z73.3 F41.9 Stress, not elsewhere classified Anxiety disorder, unspecified Behavior N/A Intervention group: 8 sessions of counseling with cognitive-behavioral approach will be held for 45-60 minutes once a week in a calm environment and in groups (5 to 7 people in each group). The content of these sessions includes initial psychological assessment, reorganization of concepts, use of clinical skills, strengthening skills and how to use them, generalization and maintenance, follow-up and evaluation after intervention. Control group: Participants in the control group will receive routine care. Stress. Timepoint: Before and after intervention. Method of measurement: Perceived stress questionnaire. Anxiety. Timepoint: Before and after intervention. Method of measurement: Spielberger Anxiety Inventory. Depression. Timepoint: Before and after intervention. Method of measurement: Beck Depression Inventory. Self-esteem. Timepoint: Before and after intervention. Method of measurement: Rosenberg Self-Esteem Questionnaire. Tabriz University of Medical Sciences Approved 2021-01-23 Ethics committee of Tabriz University of Medical Sciences Reaserch department, third floor, headquarters number 2, Tabriz University of Medical Sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)