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IRCT20230901059319N1 IRCT 2023-10-05 Khatam University Investigating the effectiveness of integrated psychotherapy on generalized anxiety disorder A Combined Protocol of Emotional Schema Therapy and Integrated Transdiagnostic Therapy on Brain Executive Functions and Emotional Regulation in People with Generalized Anxiety Disorder 2023-09-13 anticipated 5 Complete https://irct.ir/trial/72378 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Generalized anxiety disorder. "Intervention group: 5 participants in the research study, diagnosed with generalized anxiety disorder, participate in 10 individual psychotherapy sessions.The duration of each session is one hour. During the sessions Using the integrated protocol of Leahy's emotional schema therapy and Barlow's integrative transdiagnostic therapy , the evaluation and modification of emotional schemas, cognitive reconstruction, training and application of mindfulness, emotional regulation, and cognitive flexibility are addressed. Description of the intervention : Pre- Assessment The first stage involves a comprehensive assessment to evaluate the patient's level of anxiety, emotional regulation abilities, and executive function performance. Standardized assessment tools like the Generalized Anxiety Disorder 7-item (GAD-7) scale, Cognitive Regulation of Emotion Questionnaire (Garnefski and Kraaij, 2006), and Persian version of Adult Executive Functions Scale (Parhun et al., 2023) will be used. Schema Identification : We begin by identifying the patient's schemas that relate to their anxiety, focusing on the cognitive, emotional, and behavioral responses that contribute to their Generalized anxiety disorder. Schema Modification : Through a process of cognitive restructuring, patients are guided to challenge their schemas, change their maladaptive thought patterns, and develop healthier ways of interpreting their experiences.Emotional Regulation Training : We utilize the techniques from Dialectical Behavior Therapy (DBT) and Acceptance and Commitment Therapy (ACT) to teach patients skills to understand and manage their emotions better. Cognitive Flexibility Training : Using a combination of cognitive-behavioral techniques and mindfulness practices, we aim to enhance the patient's ability to shift their attention and adapt their thinking in response to changing circumstances. Schema- Focused Emotional Regulation : After separately working on Emotional Schema Therapy and Integrated Transdiagnostic Therapy , we integrate the two by focusing on schema-focused emotional regulation. This helps patients recognize and alter schemas while simultaneously regulating their emotions. Cognitive Flexibility and Schema Modification: As patients gain better control over their emotional responses, we further integrate cognitive flexibility training within schema modification, which aids them to challenge and change their schemas more effectively.Post- Assessment : The same standardized tools used in the pre-assessment will be employed to evaluate the progress and efficacy of the therapy. Finally, patients are provided with strategies and plans to maintain their gains and cope with potential future stressors. Regular follow-ups are conducted to reinforce the therapy's effectiveness and manage any recurring symptoms. No - There is not a plan to make this available Justification or reason for not sharing IPD is "Since the research plan is related to a thesis, only the study protocol, clinical study report, and study results will be published. The participant data file contains information about the participants, and due to the preservation of individuals' privacy, it cannot be published."
public Mahsa Khajooei
No.30, Hakim Azam St., Shiraz North St., Mollasadrah St., Khatam University Psychological and Counseling Clinic
Tehran Iran (Islamic Republic of) 1991633357 +98 21 8917 0000 m.khajavi@khatam.ac.ir Khatam University scientific Marzie Hashemi
No.30, Hakim Azam St., Shiraz North St., Mollasadrah St., Khatam University
Tehran Iran (Islamic Republic of) 1991633357 +98 21 8917 0000 hashemi.hs@gmail.com Khatam University Iran (Islamic Republic of) Clients to the Imam Hossein psychiatric clinic in Tehran Diagnosed with generalized anxiety disorder (based on a psychiatric specialist's diagnosis) At least 4 weeks should have passed since the medications were stabilized Age range of 20 to 45 years Middle socio-economic level Intermediate level of education (from diploma to bachelor's degree) 20 years 45 years Both Diagnosed Social anxiety disorder (based on a psychiatric specialist's diagnosis) Patients with delusions and hallucinations (psychosis) Patients with verbal disabilities (due to the impossibility of obtaining information from them) Patients with generalized anxiety disorder who are currently going to psychotherapy sessions. Patients with thyroid problems Patients using drugs Diagnosed with a mental disorder comorbid F41.1 Generalized anxiety disorder Treatment - Other "Intervention group: 5 participants in the research study, diagnosed with generalized anxiety disorder, participate in 10 individual psychotherapy sessions.The duration of each session is one hour. During the sessions Using the integrated protocol of Leahy's emotional schema therapy and Barlow's integrative transdiagnostic therapy , the evaluation and modification of emotional schemas, cognitive reconstruction, training and application of mindfulness, emotional regulation, and cognitive flexibility are addressed. Description of the intervention : Pre- Assessment The first stage involves a comprehensive assessment to evaluate the patient's level of anxiety, emotional regulation abilities, and executive function performance. Standardized assessment tools like the Generalized Anxiety Disorder 7-item (GAD-7) scale, Cognitive Regulation of Emotion Questionnaire (Garnefski and Kraaij, 2006), and Persian version of Adult Executive Functions Scale (Parhun et al., 2023) will be used. Schema Identification : We begin by identifying the patient's schemas that relate to their anxiety, focusing on the cognitive, emotional, and behavioral responses that contribute to their Generalized anxiety disorder. Schema Modification : Through a process of cognitive restructuring, patients are guided to challenge their schemas, change their maladaptive thought patterns, and develop healthier ways of interpreting their experiences.Emotional Regulation Training : We utilize the techniques from Dialectical Behavior Therapy (DBT) and Acceptance and Commitment Therapy (ACT) to teach patients skills to understand and manage their emotions better. Cognitive Flexibility Training : Using a combination of cognitive-behavioral techniques and mindfulness practices, we aim to enhance the patient's ability to shift their attention and adapt their thinking in response to changing circumstances. Schema- Focused Emotional Regulation : After separately working on Emotional Schema Therapy and Integrated Transdiagnostic Therapy , we integrate the two by focusing on schema-focused emotional regulation. This helps patients recognize and alter schemas while simultaneously regulating their emotions. Cognitive Flexibility and Schema Modification: As patients gain better control over their emotional responses, we further integrate cognitive flexibility training within schema modification, which aids them to challenge and change their schemas more effectively.Post- Assessment : The same standardized tools used in the pre-assessment will be employed to evaluate the progress and efficacy of the therapy. Finally, patients are provided with strategies and plans to maintain their gains and cope with potential future stressors. Regular follow-ups are conducted to reinforce the therapy's effectiveness and manage any recurring symptoms The score of Executive Functions the short Persian form (Parhun et al., 2023) of the Adult Self-Report of Executive Functions Scale (Roth et al.) is obtained. Timepoint: "Before the start of the study, three times at intervals of one week, then at 3, 6, 9 weeks after the start of psychotherapy sessions, once at the end of the treatment, and once 1 month after the end of therapy sessions.". Method of measurement: Persian version of Adult Executive Functions Scale (normized version of Behavioral Rating of Executive Functions) Roth et al. The score of the Cognitive Emotion Regulation Questionnaire (Garnefski and Kraaij, 2006). Timepoint: "Before the start of the study, three times at intervals of one week, then at 3, 6, 9 weeks after the start of psychotherapy sessions, once at the end of the treatment, and once 1 month after the end of therapy sessions.". Method of measurement: Cognitive Regulation of Emotion Questionnaire (Garnefski and Kraaij, 2006). The score of the Generalized Anxiety Disorder questionnaire (GAD-7). Timepoint: "Before the start of the study, three times at intervals of one week, then at 3, 6, 9 weeks after the start of psychotherapy sessions, once at the end of the treatment, and once 1 month after the end of therapy sessions.". Method of measurement: Generalized Anxiety Disorder Scale Questionnaire (GAD-7). Khatam University Approved 2023-08-29 Ethics Committee of Shahid Beheshti University Shahid Shahriari square., Evin., Tehran Tehran Tehran Iran (Islamic Republic of)