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IRCT20240910063001N2 IRCT 2024-10-05 Bagheiat-allah University of Medical Sciences Expressive writing and acceptance and commitment therapy for stress and anxiety The impact of expressive writing versus acceptance and commitment therapy on inflammatory biomarkers, cognitive functioning, and psychological well-being in high-school students with moderate-to-severe stress or anxiety 2024-10-22 anticipated 48 Complete https://irct.ir/trial/79131 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be divided into two groups, ACT and EW, using the random block method. Block randomization will be conducted using the website https://www.sealedenvelope.com. Each block will consist of four members, and the resulting combination will be as follows: [ABAB], [ABBA], [AABB], [BBAA], [BABA], [BAAB], where code "A" corresponds to the EW group and code "B" corresponds to the ACT group. The aforementioned website randomly selects 12 quadruple blocks, thus including 48 patients in the study. To ensure the allocation is concealed, a code is devised for each participant based on the generated blocks. These codes will be provided to the researcher at the time of admission by the study coordinator. N/A Condition 1: Stress, not elsewhere classified. Condition 2: Anxiety disorder, unspecified. Intervention 1: Intervention group (EW): a course of expressive writing therapy, comprising three consecutive days of therapy per week, with each session lasting 15 minutes, over a period of six weeks. The therapy was conducted under the guidance of a psychology expert, with follow-up sessions conducted via telephone. Intervention 2: Control group (ACT): a course of acceptance and commitment therapy in the form of six one-hour group sessions over six weeks based on the headings of the educational protocol of acceptance and commitment therapy. Yes - There is a plan to make this available What will be shared: All data can be shared after participants are de-identified When: Six months after the results have been published To whom: Academic and scientific institutions Conditions: Systematic review studies and meta-analysis Where to obtain: Shima Shahyad How to obtain: Send an email to the corresponding author Comments:
public Shima Shahyad
Institute of Systems Biology and Personalized Medicine, Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8755 4148 shima.shahyad@gmail.com Bagheiat-allah University of Medical Sciences scientific Shima Shahyad
Institute of Systems Biology and Personalized Medicine, Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8755 4148 shima.shahyad@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Be between the ages of 15 and 20 A stress score of more than 18 or an anxiety score of more than 9 in the psychological interview based on the Depression, Anxiety and Stress Scale-42 Informed consent of the patient and legal guardian for participation 15 years 20 years Both History of significant psychiatric, neurological, or endocrine disorders Prior engagement in psychotherapy Current pharmacological treatment with psychotropic medications or steroids Lack of compliance, defined as failure to participate in more than two follow-up sessions Z73.3 F41.9 Physical and mental strain NOS Anxiety NOS Behavior Behavior Intervention group (EW): a course of expressive writing therapy, comprising three consecutive days of therapy per week, with each session lasting 15 minutes, over a period of six weeks. The therapy was conducted under the guidance of a psychology expert, with follow-up sessions conducted via telephone Control group (ACT): a course of acceptance and commitment therapy in the form of six one-hour group sessions over six weeks based on the headings of the educational protocol of acceptance and commitment therapy Serum cortisol. Timepoint: Before the start of the intervention and one week after its end (week 7). Method of measurement: Laboratory test. Serum C-reactive protein. Timepoint: Before the start of the intervention and one week after its end (week 7). Method of measurement: Laboratory test. Neutrophil-to-lymphocyte ratio. Timepoint: Before the start of the intervention and one week after its end (week 7). Method of measurement: Laboratory test. Working memory and processing speed. Timepoint: Before the start of the intervention and one week after its end (week 7). Method of measurement: Paced Auditory Serial Addition Test. Stress. Timepoint: Before the start of the intervention and one week after its end (week 7). Method of measurement: Depression, Anxiety, Stress Scale-42. Anxiety. Timepoint: Before the start of the intervention and one week after its end (week 7). Method of measurement: Depression, Anxiety, Stress Scale-42. Bagheiat-allah University of Medical Sciences Approved 2024-09-16 Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran Tehran Tehran Iran (Islamic Republic of)