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IRCT20200305046699N1 IRCT 2020-04-22 Islamic Azad University The Effectiveness of Group Therapy Based on Mindfulness and cognitive-behavioral therapy (CBT) in the anxiety, metabolic control and quality of life in type 2 diabetic patients The Effectiveness of Group Therapy Based on Mindfulness and cognitive-behavioral therapy (CBT) in the anxiety, metabolic control and quality of life in type 2 diabetic patients 2020-01-07 anticipated 45 Complete https://irct.ir/trial/46398 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using the block randomization method by the statistical consultant, the following randomization is done in 3 groups of mindfulness-based cognitive therapy, cognitive-behavioral therapy, and control: First, the list of names of qualified people is provided and coded. In block randomization, the number of participants in all groups will be very close, this is done by building blocks of sequences and intersections so that the same number of participants are allocated to study groups within each group. First, we encode the groups based on the Latin letters as follows: A = mindfulness-based cognitive therapy, B = cognitive-behavioral therapy and C control group In this study, with three groups A, B, and C, we create the following six groups and assign the numbers 1 to 6 to each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the table of random numbers, we contract that if the numbers 1, 2, 3, 4, 5, 6, and 6 appear in order, one of these blocks will be selected, and if another number appears, we will assume it to be null and void and move on to the next selection. In fact, we have obtained a random sequence of numbers with a table of random numbers, which we consider the order of the assigned allocation for each number. In this way, the number of people in the groups will be almost equal. 2 Diabetes Type II. Intervention 1: Intervention group one: It is a collection of training and treatment instructions and homework that will be presented to people during 8 sessions of one and a half hours. The Practical Guide to Mindfulness Therapy will be used to help people (Kabat-Zinn, 2012), and the Personalized Mindfulness Therapy Handbook will be used as the main source of therapeutic techniques. Mindfulness-based cognitive therapy was taught to participants based on Kabat‐Zinn (2012) in 8 sessions (two sessions per week, each session for 90 minutes) and during one month. Intervention 2: Second Intervention Group: It is a collection of training and treatment instructions and homework that will be presented to people during 8 sessions of one and a half hours. The Practical Guide to Cognitive-Behavioral Therapy will be used to help people take control of their lives (Lam, 2008), and the Individual Guide to Cognitive Behavioral Therapy and the Guide to Group Cognitive Behavioral Therapy will be used as the main source of therapeutic techniques. But there is no limit to the use of other cognitive-behavioral techniques. In this study, cognitive-behavioral intervention with the help of Lam Training Package (2008) was taught to participants in 8 sessions (one session per week and 90 minutes per session) for one and a half months. Intervention 3: Control group: No Intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Fatemeh Rezaei kookhdan
No.2, west 14th, North Allameh st, Saadatabad
Tehran Iran (Islamic Republic of) 2255689744 +98 21 2233 9948 f.rezaeikookhdan@iaukishint.ac.ir Islamic Azad University scientific Fatemeh Rezaei kookhdan
No.2, west 14th, North Allameh st, Saadatabad
Tehran Iran (Islamic Republic of) 2255689744 +98 21 2233 9948 f.rezaeikookhdan@iaukishint.ac.ir Islamic Azad University Iran (Islamic Republic of) Age range 25 to 45 years Having type 2 diabetes Having a sense of cooperation and satisfaction in participating in therapeutic intervention Have at least a diploma literacy (to read and write) 25 years 45 years Both Having chronic mental disorders Having severe depression Having a chronic physical illness with diabetes, such as blindness Amputation E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other N/A Intervention group one: It is a collection of training and treatment instructions and homework that will be presented to people during 8 sessions of one and a half hours. The Practical Guide to Mindfulness Therapy will be used to help people (Kabat-Zinn, 2012), and the Personalized Mindfulness Therapy Handbook will be used as the main source of therapeutic techniques. Mindfulness-based cognitive therapy was taught to participants based on Kabat‐Zinn (2012) in 8 sessions (two sessions per week, each session for 90 minutes) and during one month. Second Intervention Group: It is a collection of training and treatment instructions and homework that will be presented to people during 8 sessions of one and a half hours. The Practical Guide to Cognitive-Behavioral Therapy will be used to help people take control of their lives (Lam, 2008), and the Individual Guide to Cognitive Behavioral Therapy and the Guide to Group Cognitive Behavioral Therapy will be used as the main source of therapeutic techniques. But there is no limit to the use of other cognitive-behavioral techniques. In this study, cognitive-behavioral intervention with the help of Lam Training Package (2008) was taught to participants in 8 sessions (one session per week and 90 minutes per session) for one and a half months. Control group: No Intervention Anxiety. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Spielberger State-Trait Anxiety Inventory. Metabolic control. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Blood glucose test. Quality of Life. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Quality of Life Questionnaire. Islamic Azad University Approved 2019-12-07 Ethics committee of Hormozgan University of Medical Sciences No.2, Shahid Karami Alley, North Allameh, Sa'adatabad Tehran Tehran Iran (Islamic Republic of)