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IRCT20220316054306N5 IRCT 2024-09-26 Shahid Beheshti University of Medical Sciences Cognitive behavioral therapy and psychotherapy based on acceptance and commitment for caregivers of cancer patients Comparing the effectiveness of online mindfulness-integrated CBT and acceptance and commitment on psychological symptoms of cancer caregivers with control group 2024-10-22 anticipated 45 Complete https://irct.ir/trial/79075 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the people who entered the study were given a code, then these codes were entered into the Randomly assign online software (https://www.graphpad.com/quickcalcs/randomize1.cfm) and the software randomly assigned each code to a group. N/A Caregivers of cancer patients. Intervention 1: Intervention group: Cognitive behavioral therapy based on mindfulness will be conducted in 4 sessions of 75 minutes once a week, structured as follows:Session 1: Introduction to MiCBT treatment, explanation of its structure, introduction of three learning methods to clients, identification and adjustment of treatment goals with clients, emphasis on the need for regular practice of exercises and homework, introduction of PMR progressive muscle relaxation, introduction of physical mindfulness, explanation of homework and distribution of worksheets. Session 2: Introduction to breathing mindfulness and its rationale for clients, discussion of obstacles to mindfulness practice, cognitive mindfulness exercises, review of homework and progress, deepening of the experience, explanation of homework, and distribution of worksheets. Session 3: Review homework and progress, explain the physical examination rationale, introduce the four characteristics of bodily sensations, explain the homework, and distribute the worksheets. Session 4: Review of homework and progress, the introduction of silent practice, the introduction of stillness and immobility, measurement of composure and projection, explanation of homework, and distribution of worksheets. Intervention 2: Intervention group: Psychotherapy based on acceptance and commitment: First session: Establishing communication and introducing the intervention topic. Second session: Exploring and reviewing therapeutic and educational methods, evaluating their effectiveness, and discussing temporary and ineffective methods using parables. Third session: Identifying ineffective strategies and accepting painful personal events without conflict using metaphors. Fourth session: Explaining how to avoid painful experiences and understand the consequences, followed by step-by-step teaching of acceptance. Fifth session: Introducing the three-dimensional behavioral model to illustrate the relationship between behavior/emotions, psychological functions, and observable behavior. Discussing efforts to change behavior based on this model. Sixth session: Explaining the concepts of role and context, introducing the idea of values, creating motivation for change, and fostering commitment to action. 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 Shahab Lotfinia
No.13, Asadimanesh ave, Monireih Blvd, Tehran
Tehran Iran (Islamic Republic of) 3816149369 +98 21 23871 lotfiniashahab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Amir Sam Kianimoghadam
No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9770 kianimoghadam@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Being caregiver of a cancer patient Age between 18 and 50 years At least a diploma education Ability to use smartphones Have no neurological disorders 18 years 50 years Both Treatment - Other Treatment - Other Intervention group: Cognitive behavioral therapy based on mindfulness will be conducted in 4 sessions of 75 minutes once a week, structured as follows:Session 1: Introduction to MiCBT treatment, explanation of its structure, introduction of three learning methods to clients, identification and adjustment of treatment goals with clients, emphasis on the need for regular practice of exercises and homework, introduction of PMR progressive muscle relaxation, introduction of physical mindfulness, explanation of homework and distribution of worksheets. Session 2: Introduction to breathing mindfulness and its rationale for clients, discussion of obstacles to mindfulness practice, cognitive mindfulness exercises, review of homework and progress, deepening of the experience, explanation of homework, and distribution of worksheets. Session 3: Review homework and progress, explain the physical examination rationale, introduce the four characteristics of bodily sensations, explain the homework, and distribute the worksheets. Session 4: Review of homework and progress, the introduction of silent practice, the introduction of stillness and immobility, measurement of composure and projection, explanation of homework, and distribution of worksheets. Intervention group: Psychotherapy based on acceptance and commitment: First session: Establishing communication and introducing the intervention topic. Second session: Exploring and reviewing therapeutic and educational methods, evaluating their effectiveness, and discussing temporary and ineffective methods using parables. Third session: Identifying ineffective strategies and accepting painful personal events without conflict using metaphors. Fourth session: Explaining how to avoid painful experiences and understand the consequences, followed by step-by-step teaching of acceptance. Fifth session: Introducing the three-dimensional behavioral model to illustrate the relationship between behavior/emotions, psychological functions, and observable behavior. Discussing efforts to change behavior based on this model. Sixth session: Explaining the concepts of role and context, introducing the idea of values, creating motivation for change, and fostering commitment to action. Severity of depressive symptoms. Timepoint: Before and after intervention. Method of measurement: Based on the score obtained in Depression Anxiety Stress Scale. Severity of anxiety symptoms. Timepoint: Before and after intervention. Method of measurement: Depression Anxiety Stress Scales. Severity of stress. Timepoint: Before and after intervention. Method of measurement: Depression Anxiety Stress Scales. The amount of quality of life. Timepoint: Before and after intervention. Method of measurement: Based on the score obtained in the World Health Organization Quality of Life Scale. Severity of caregiver burdon. Timepoint: Before and after intervention. Method of measurement: Based on Caregiver Burden Inventory (CBI). Shahid Beheshti University of Medical Sciences Approved 2024-07-21 Ethics committe of Shahid Beheshti University of Medical Science Bldg No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)