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IRCT20180313039082N1 IRCT 2018-06-26 Ahvaz University of Medical Sciences The Effect of Group Cognitive-Behavioral Therapy(CBT) on Sleep disorders The Effect of Group Cognitive-Behavioral Therapy(CBT) on Sleep disorders in Postmenopausal Women 2018-04-21 anticipated 46 Complete https://irct.ir/trial/30246 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: A randomized controlled trial with a control group, randomized, with a block allocation to the groups, Randomization description: In order to do the intervention, the women will be divided into two groups of 23 participant as control and intervention groups using block randomization with a block size of four and allocation ratio of one. For allocation concealment of women in the intervention and control groups, 23 4-digit even numbers will be chosen from random numbers as codes for participants of control group and 23 4-digit odd numbers for participants of intervention group will be chosen from random numbers table and they will be written according to the order of blocks. Then, the number of intervention and control groups will put in the opac envelops and then the envelops will be closed and they will be given randomly to the eligible women in the study by the secretary of menopause clinic (the researcher and the participant will not informed about allocation until the last moment. N/A sleep disorders in menopausal women. Intervention 1: Intervention group:for this group 6 sessions of 90 minutes counseling of cognitive behavior therapy will be held weekly.The content of sessions will be as follow: First session: introduction and orientation with group members, concept of menopause and changes during menopause, concept of insomnia models, sleep restriction and controlling the stimulants.Second and third sessions: management of sleep health and therapeutic cognitive with the aim of modifying the dysfunctional beliefs about sleep and effects of insomnia on daily performance will be tought. Fourth and fifth sessions: cognitive-behavioral treatment principles will be reinforced, and the sleep program will be adjusted according to the information of daily sleep log report. Sixth session: it will be focused on prevention from relapse and skills to deal with failures. Intervention 2: Control group: For this group, participants will complete the sleep disorder questionnaires and they will receive the routine care at postmenopausal clinic of the Imam Khomeini Hospital in Ahvaz. Yes - There is a plan to make this available What will be shared: All data will be shareable after making the patients unidentifiable. When: Start the access period one year after the publication To whom: Only for researchers working in academic and scientific institutions. Conditions: The data are accessible by mentioning the name of the investigator and for clinical and research actions. Where to obtain: Ms. Poorandokht Afshari. Faculty Member of Ahvaz Jundishapur University. Email address: p_afshary@yahoo.com How to obtain: Send the request by email and respond as soon as possible Comments:
public Poorandokht Afshari
Menopause and Andropause Research Center, Faculty of Nursing and Midwifery, Jundishapur University of Medical Science,Golestan st.
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8619 p_afshary@yahoo.com Ahvaz University of Medical Sciences scientific Poorandokht Afshari
Menopause and Andropause Research Center, Faculty of Nursing and Midwifery, Jundishapur University of Medical Science,Golestan st. Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8619 p_afshary@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Being at the age of 40- 60 years Passing for at least one year and up to 5 years from menopause Being married Literacy at least at a high school education Having sleep disorder, according to the Insomnia Severity Index and Pitsburg Sleep Quality questionnaire Willingness to participate in this study and providing written consent 40 years 60 years Female Presence of medical problems Interfering with sleep disorders Work at night shift recent participation in psychotherapy or cognitive-behavioral therapy for other problems. Recent severe trauma during the last three months Taking sleeping and antipsychotics medications Having mental illnesses such as severe depression and severe anxiety, that may leading to sleep problems Smoking (more than 10 cigarettes a day), drug and alcohol use G47 Sleep disorders Treatment - Other Other Intervention group:for this group 6 sessions of 90 minutes counseling of cognitive behavior therapy will be held weekly.The content of sessions will be as follow: First session: introduction and orientation with group members, concept of menopause and changes during menopause, concept of insomnia models, sleep restriction and controlling the stimulants.Second and third sessions: management of sleep health and therapeutic cognitive with the aim of modifying the dysfunctional beliefs about sleep and effects of insomnia on daily performance will be tought. Fourth and fifth sessions: cognitive-behavioral treatment principles will be reinforced, and the sleep program will be adjusted according to the information of daily sleep log report. Sixth session: it will be focused on prevention from relapse and skills to deal with failures. Control group: For this group, participants will complete the sleep disorder questionnaires and they will receive the routine care at postmenopausal clinic of the Imam Khomeini Hospital in Ahvaz. Sleep disorders. Timepoint: Sleep disorders (at the beginning of the intervention), before the intervention, 3, 6, and 10 weeks after the intervention. Method of measurement: Insomnia Severity Index, Pitsburg Sleep Quality Index, Sleep Log. Ahvaz University of Medical Sciences Approved 2018-04-21 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University Medical Science, Golestan Ave. Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)