]>
IRCT20231209060301N1 IRCT 2023-12-23 Ahvaz University of Medical Sciences The effect of acceptance and commitment therapy with two methods of internet-based and bibliotherapy on anxiety and depression Investigating the effect of Acceptance and Commitment Therapy (ACT) with two methods of internet-based and bibliotherapy on anxiety and depression in patients with breast cancer 2023-12-31 anticipated 99 Complete https://irct.ir/trial/74230 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Before sampling, a statistician creates a random allocation algorithm using R statistical software, with random block sizes of 7, 14, 21 and 28 and an equal allocation ratio (33 people in each arm). 99 patients using Permutation block randomization method and equal allocation ratio are randomly assigned to one of the 3 study groups, Blinding description: A statistician creates a random allocation algorithm before sampling using R statistical software and then analyzes the data and will be blinded in both steps. The participants in each group are aware of the implementation method and the researcher, who is responsible for communicating with the people in the groups, knows about the people in each group, so these two are not blind. N/A Condition 1: ِِDepression. Condition 2: ِِDepression. Condition 3: Anxiety. Condition 4: Breast cancer. Intervention 1: Intervention group: bibliotherapy; In this group, a printed or electronic version of the book Flying over thunderstorms is presented, the cost of which has been paid. The intervention (study and practice) does not require an in-person visit, and patients can do it at any place and time they want. They are requested to use the book for a period of one and a half months in such a way that they study and practice a specific part of the book, which has about 40 pages, every week. They can do this at their own pace, time and place, and can review as many times as they want. Intervention 2: Intervention group: Internet-based intervention; All participants in this group must have access to a smart phone or computer. Weekly meetings are held in the virtual space of the university. The link is sent to the patients along with the guide to participate in the meetings. An internet package is prepared for the connection of each patient. The content of the sessions is actually the same as the bibliotherapy group that is taught online by a psychiatric nurse. Then the participants ask their questions and the guide answers them. Patients' exercises are provided to them in the form of pdf and printed files, which they should do and review as much as they can until the next session. Intervention 3: Control group: Participants in the control group receive routine hospital care provided by health care centers. After completing the interventions of the other two groups and performing the post-test, this group can receive any of the interventions of the other groups as they wish. Yes - There is a plan to make this available What will be shared: The data file will be shared with the SPSS software format When: The access period begins after the publication of the findings in the form of a printed article To whom: The data will be available to researchers working in academic institutions Conditions: Data will only be available for use in review studies and meta-analyses Where to obtain: Through Kourosh Zarea's academic email:zarea_k@ajums.ac.ir How to obtain: Send an email to the author and mention the purpose of receiving the information. If there are no problems, you will receive the information one to three weeks later Comments:
public Kourosh Zarea
Golestan Ave
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 2660 zarea_k@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr Kourosh Zarea
2nd floor, Faculty of Nursing and Midwifery
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 2660 zarea_k@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women aged 18 and over Reading and writing literacy in Persian language Interested in participating in a research project Being able to make phone calls and receive SMS Signed written informed consent The use of conventional psychotropic drugs is accepted only if the dosage has been stable for the past 3 months The possibility of using a computer and / or smartphone and the Internet Daily access to the Internet by computer and / or smartphone The ability to participate in research in terms of physical and cognitive Having clinically significant symptoms of mild to moderate anxiety (BAI scores 8 to 25) and/or mild to moderate depression (BDI-S scores 5 to 15) 18 years no limit Female Significant cognitive impairment or communication problem that affects the ability to provide consent or participate in the study Suffering from other medical diseases and other types of cancer and mental disorders Participating in other interventional research projects at the same time History of participation or intention to participate in an educational workshop that covers the content of the intervention of this research (ACT) Unstable or severe physical or mental conditions Inability to cooperate and give informed consent Having metastatic breast cancer Severe mental illness or disorder or ongoing psychological treatment Inability to use a computer and / or smartphone and the Internet Inability or unwillingness to comply with study requirements Participants who underwent removal of a breast cyst, limited arm and/or shoulder motion, treatment for another type of cancer or diagnosis of another type of cancer, or breast reconstruction Absence of more than one session in intervention group meetings F32.0 F32.1 F41.9 D05 Major depressive disorder, single episode, mild Major depressive disorder, single episode, moderate Anxiety disorder, unspecified Carcinoma in situ of breast Behavior Behavior Behavior Intervention group: bibliotherapy; In this group, a printed or electronic version of the book Flying over thunderstorms is presented, the cost of which has been paid. The intervention (study and practice) does not require an in-person visit, and patients can do it at any place and time they want. They are requested to use the book for a period of one and a half months in such a way that they study and practice a specific part of the book, which has about 40 pages, every week. They can do this at their own pace, time and place, and can review as many times as they want Intervention group: Internet-based intervention; All participants in this group must have access to a smart phone or computer. Weekly meetings are held in the virtual space of the university. The link is sent to the patients along with the guide to participate in the meetings. An internet package is prepared for the connection of each patient. The content of the sessions is actually the same as the bibliotherapy group that is taught online by a psychiatric nurse. Then the participants ask their questions and the guide answers them. Patients' exercises are provided to them in the form of pdf and printed files, which they should do and review as much as they can until the next session Control group: Participants in the control group receive routine hospital care provided by health care centers. After completing the interventions of the other two groups and performing the post-test, this group can receive any of the interventions of the other groups as they wish Depression score in short form Beck depression inventory. Timepoint: Before the intervention, after the intervention, 4 weeks after the intervention. Method of measurement: Beck depression short inventory. Anxiety score in Beck anxiety inventory. Timepoint: Before the intervention, after the intervention, 4 weeks after the intervention. Method of measurement: Beck anxiety inventory. Ahvaz University of Medical Sciences Approved 2023-12-02 Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences Golestan Ave Ahvaz Khouzestan Iran (Islamic Republic of)