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IRCT20231128060213N1 IRCT 2024-01-05 Islamic Azad University Investigating the effect of cognitive behavioral therapy on patients with generalized anxiety disorder. The Effectiveness of Metacognitive Therapy on Believability of Anxious Feeling and Thought, Emotional Distress Tolerance and Medication Adherence in Patients with Generalized Anxiety Disorder 2023-11-15 anticipated 32 Complete https://irct.ir/trial/74037 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 32 people are selected using GPOWER software in an accessible way. Then random replacement is done by lottery method (one number is assigned to each sample). We write down the numbers on the paper, fold them and put them in the container. We mix and stir the papers completely. Then we take out the papers one by one and put one number in the first group and one number in the second group. Then random application will be done. In this way, one group is known as "control group" and the other group is known as "intervention group". The lottery will be done by putting the two groups obtained from the previous step (random replacement step) into two separate envelopes and placing them in a container. Then we randomly take out an envelope that contains 16 numbers from the container and assign it to the "intervention group" and the other envelope that also contains 16 numbers to the "control group". Finally, the intervention group: receive 8 sessions of 120 minutes of metacognitive therapy for generalized anxiety of Wells, and the second group, as a control group, does not receive any psychological treatment. N/A Patients with Generalized Anxiety Disorder. Intervention 1: Intervention group: In this study, there is an experimental group and a control group. Before the intervention, research participants will undergo pre-tests of credible beliefs and anxiety-related variables, emotional distress tolerance, and medication adherence. After this stage, participants in the experimental group will receive 8 sessions of 120-minute cognitive-behavioral therapy for generalized anxiety, while the control group will not receive any training. Subsequently, participants from both the experimental and control groups will undergo post-tests. The content of the sessions is as follows: 1. Pre-test execution, preparation, and introduction to cognitive-behavioral therapy, presentation of cognitive-behavioral therapy rationale. 2. Familiarization with cognitive attention syndrome and its impact on the continuity of mental disorders, questioning about the effectiveness of self-regulatory behaviors (coping), suppression of thoughts experiment. 3. Challenging negative cognitive beliefs related to uncontrollable thoughts, negative thoughts, and emotions, teaching independent mindfulness exercises, independent mindfulness exercises about neutral thoughts. 4. Continued challenge with uncontrollability beliefs (examining opposing evidence), delaying thoughts experiment, loss of control experiment in therapy session. 5. Challenging positive cognitive beliefs related to uncontrollability of danger and harm, introduction to verbal methods and behavioral experiments. 6. Challenging positive cognitive beliefs, presenting non-matching and inconsistency strategies, modifying cognitive thought experiments. 7. Presentation of a new processing plan including: identifying the process of thoughts-anxieties-stresses-emotions and worries, emphasizing the use of independent attention for triggering thoughts, allowing emotions and thoughts to peak and subside without effort to control them, repeated execution of new thinking styles. 8. Monitoring progress, presenting a summary of techniques presented in all therapy sessions, answering questions and problems in using these techniques, getting feedback from all sessions, conducting post-tests. Intervention 2: Control group: The control group will undergo pre-tests and post-tests for variables such as belief in thoughts and anxiety, tolerance of emotional distress, and adherence to medication, and will not receive cognitive-behavioral therapy intervention. Yes - There is a plan to make this available What will be shared: The main results will be shared after the end of the study. When: 6 months To whom: Upon request, the study results will be made available to other academic researchers Conditions: The collected data is confidential and will not be shared with others Where to obtain: To receive documents, send an email to the person responsible for updating How to obtain: Within 15 days, the documents will be sent by email Comments:
public Ghodratollah Abbasi
5th floor Humanities Building, Azad University , Farah Abad Road, Khazar Square
Sari Iran (Islamic Republic of) 4816119318 +98 11 3303 2891 gh_abbasi@iausari.ac.ir Islamic Azad University scientific Ghodratollah Abbasi
5th floor Humanities Building, Azad University , Farah Abad Road, Khazar Square
Sari Iran (Islamic Republic of) 4816119318 +98 11 3303 2891 gh_abbasi@iausari.ac.ir Islamic Azad University Iran (Islamic Republic of) Having informed consent and the ability to participate in therapy sessions Having generalized anxiety disorder (scoring above the cutoff point on the Generalized Anxiety Disorder 7-item scale (GAD-7) and initial clinical interview) Having literacy in reading and writing Being aged 18 to 50 Needing medication treatment. 18 years 50 years Both Individuals with a history of psychiatric symptoms and psychosis diagnosed by a psychiatrist history of hospitalization in a neurology and psychiatry hospital Simultaneous use of alcohol and substance abuse disorder Major psychiatric disorders such as major depressive disorder, bipolar disorder, and major cognitive disorders Suffering from a significant physical illness Participating in psychotherapy sessions simultaneously. F41.1 Generalized anxiety disorder Behavior Behavior Intervention group: In this study, there is an experimental group and a control group. Before the intervention, research participants will undergo pre-tests of credible beliefs and anxiety-related variables, emotional distress tolerance, and medication adherence. After this stage, participants in the experimental group will receive 8 sessions of 120-minute cognitive-behavioral therapy for generalized anxiety, while the control group will not receive any training. Subsequently, participants from both the experimental and control groups will undergo post-tests. The content of the sessions is as follows: 1. Pre-test execution, preparation, and introduction to cognitive-behavioral therapy, presentation of cognitive-behavioral therapy rationale. 2. Familiarization with cognitive attention syndrome and its impact on the continuity of mental disorders, questioning about the effectiveness of self-regulatory behaviors (coping), suppression of thoughts experiment. 3. Challenging negative cognitive beliefs related to uncontrollable thoughts, negative thoughts, and emotions, teaching independent mindfulness exercises, independent mindfulness exercises about neutral thoughts. 4. Continued challenge with uncontrollability beliefs (examining opposing evidence), delaying thoughts experiment, loss of control experiment in therapy session. 5. Challenging positive cognitive beliefs related to uncontrollability of danger and harm, introduction to verbal methods and behavioral experiments. 6. Challenging positive cognitive beliefs, presenting non-matching and inconsistency strategies, modifying cognitive thought experiments. 7. Presentation of a new processing plan including: identifying the process of thoughts-anxieties-stresses-emotions and worries, emphasizing the use of independent attention for triggering thoughts, allowing emotions and thoughts to peak and subside without effort to control them, repeated execution of new thinking styles. 8. Monitoring progress, presenting a summary of techniques presented in all therapy sessions, answering questions and problems in using these techniques, getting feedback from all sessions, conducting post-tests. Control group: The control group will undergo pre-tests and post-tests for variables such as belief in thoughts and anxiety, tolerance of emotional distress, and adherence to medication, and will not receive cognitive-behavioral therapy intervention. Believability of Anxious Feeling and Thought. Timepoint: Before the study and immediately after the intervention. Method of measurement: questionnaire Believability of Anxious Feeling and Thought. Emotional Distress Tolerance. Timepoint: Before the study and immediately after the intervention. Method of measurement: questionnaire Emotional Distress Tolerance. Medication Adherence. Timepoint: Before the study and immediately after the intervention. Method of measurement: questionnaire Medication Adherence. Islamic Azad University Approved 2023-11-14 Ethics committee of Islamic Azad University - Sari branch 5th floor, Medical Building, Azad University, Farah Abad Road, Khazar Square ,Sari. Sari Mazandaran Iran (Islamic Republic of)