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IRCT20211206053298N1 IRCT 2022-04-30 Ahvaz University of Medical Sciences The effectiveness of compassion-focused therapy on treatment outcome in patients with bipolar disorder The Effectiveness of Compassion-Focused Therapy on Treatment Outcome in Patients With Bipolar Disorder 2022-04-21 anticipated 20 Complete https://irct.ir/trial/61775 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning the intervention to individuals is randomly divided into two groups of intervention and control by the method of random permutation blocks with a size of 4 random blocks (using the table related to random permutations). The randomization list is prepared by a statistician. In this method, group A is related to the intervention and group B is considered as the control and is classified into 4 blocks including AABB, ABAB, ABBA, BBAA, BABA, BAAB.T o hide the assignment of individuals in the intervention and control groups, 20 even four-digit numbers will be selected as the codes of the participants in the control group and 20 four-digit individuals as the codes of the participants in the intervention group will be selected from a random number table. Then, the numbers of intervention and control groups are placed in sealed envelopes, respectively, and are randomly delivered by one of the personnel to the eligible individuals participating in the study. Random allocation software is also used for randomization. The site https://www.randomizer.org/ is used for randomization. In the empty fields, the total number of random numbers and the number of random numbers in each group, the range of numbers are entered and the output is received as an excel. 2-3 The effectiveness of compassion-focused therapy on treatment outcome in patients with bipolar disorder. Intervention 1: Intervention group: After the patients are selected, based on the treatment group, the patients are treated with compassion-focused treatment and after the treatment, the information is re-evaluated. The compassion-focused treatment protocol will be implemented in accordance with the content of the treatment in 10 sessions. The basic principles of compassion-focused therapy point out that external soothing thoughts, factors, images, and behaviors must be internalized, and in this case, the human mind, as it responds to external factors, in the face of this Relax inside. Sessions 1 and 2: Evaluation based on compassion-focused treatment approach, Session 3: Understanding compassion, Session 4: Preparing clients to improve compassionate attention and concentration, Session 5: Illustration of daily compassion, Session 6: Examining the role of self-criticism and shame using the metaphor of two teachers, introducing compassionate self, Session 7: Introducing multiple selves references, exercising multiple selves, Session 8: Compassionate thinking and argument and compassionate behavior, Session 9: Balancing thinking and mind in a compassionate way, Session 10: Writing a letter of compassion jects in the experimental group individually. That is, treatment sessions will be conducted individually and in the presence of the therapist and the patient. That is, 20 people will see the experimental group individually, one session per week, and the questionnaire will be filled out before the first session, after the last session, and two months after the last session, and the results will be analyzed as a group. Intervention 2: Control group: After the patients are selected, based on the treatment group, the patients are treated with world standard medicine and after the treatment, the information is re-evaluated. In this group, no compassion treatment is performed. Medication varies according to the patient's condition and the doctor's prescription. 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 more information
public Forouzan Behrouzian
Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz
Ahvaz Iran (Islamic Republic of) 157945-6135 +98 61 3374 3001 abdi.l@ajums.ac.ir Ahvaz University of Medical Sciences scientific Forouzan Behrouzian
Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz
Ahvaz Iran (Islamic Republic of) 157945-6135 +98 61 3374 3001 abdi.l@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 50 years Diagnostic Criteria - SCID-5-CV for type 1 and 2 bipolar disorder Not in the acute phase of the disease Have a regular medication regimen Score less than -17 on the Young Mania Test 18 years 50 years Both History of brain injury, dementia and specific neurological disease Not using any addictive drugs Severe physical illnesses such as cancer F31.7 Bipolar disorder, currently in remission Treatment - Other Treatment - Other Intervention group: After the patients are selected, based on the treatment group, the patients are treated with compassion-focused treatment and after the treatment, the information is re-evaluated. The compassion-focused treatment protocol will be implemented in accordance with the content of the treatment in 10 sessions. The basic principles of compassion-focused therapy point out that external soothing thoughts, factors, images, and behaviors must be internalized, and in this case, the human mind, as it responds to external factors, in the face of this Relax inside. Sessions 1 and 2: Evaluation based on compassion-focused treatment approach, Session 3: Understanding compassion, Session 4: Preparing clients to improve compassionate attention and concentration, Session 5: Illustration of daily compassion, Session 6: Examining the role of self-criticism and shame using the metaphor of two teachers, introducing compassionate self, Session 7: Introducing multiple selves references, exercising multiple selves, Session 8: Compassionate thinking and argument and compassionate behavior, Session 9: Balancing thinking and mind in a compassionate way, Session 10: Writing a letter of compassion jects in the experimental group individually. That is, treatment sessions will be conducted individually and in the presence of the therapist and the patient. That is, 20 people will see the experimental group individually, one session per week, and the questionnaire will be filled out before the first session, after the last session, and two months after the last session, and the results will be analyzed as a group Control group: After the patients are selected, based on the treatment group, the patients are treated with world standard medicine and after the treatment, the information is re-evaluated. In this group, no compassion treatment is performed. Medication varies according to the patient's condition and the doctor's prescription. Self-compassion. Timepoint: Before, after and two months after treatment. Method of measurement: Demographic Characteristics Questionnaire and Structured Clinical Interview, Distress on Bipolar Patients-Short, Self-Critical Rumination Scale. External and internal shame. Timepoint: Before, after and two months after treatment. Method of measurement: Shame Scale. Self-criticism. Timepoint: Before, after and two months after treatment. Method of measurement: Self-Critical Rumination Scale. Psychological distress. Timepoint: Before, after and two months after treatment. Method of measurement: Distress on Bipolar Patients-Short. Ahvaz University of Medical Sciences Approved 2021-11-09 Ethics committee of Ahvaz Jundishapur University of of Medical Sciences Ahvaz Jundishapur University of of Medical Sciences, Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)