]>
IRCT20240205060913N2 IRCT 2025-07-31 Shahid Beheshti University of Medical Sciences Atrial Fibrillation-Specific Cognitive Behavioral Therapy (AF-CBT) and Stress Management and Resiliency Training (SMART) in Patients with Atrial Fibrillation Comparative Effectiveness of Atrial Fibrillation-Specific Cognitive Behavioral Therapy (AF-CBT) and Stress Management and Resiliency Training (SMART) on Perceived Stress, Psychological Resilience, Quality of Life, and Sleep Quality in Patients with Atrial Fibrillation: A Randomized Clinical Trial 2025-08-01 anticipated 141 Complete https://irct.ir/trial/84988 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Patients enrolled in the study will be randomly assigned in a 1:1:1 ratio to one of three groups: “Cognitive Behavioral Therapy for Atrial Fibrillation (AF-CBT)”, “Stress Management and Resilience Training (SMART)”, and the control group. The randomization process was performed through a random number generator. An independent research assistant who will not be involved in data collection will use the Research Randomizer software (http://www.randomizer.org) to generate the random number list. A total of 141 papers, 47 of which will be printed with the number 1, 47 with the number 2, and the last 47 with the number 3 (1, 2, and 3 representing the intervention and control groups, respectively), will be sealed in an envelope that will only be accessible by the research assistant at the time of randomization, Blinding description: Due to the nature of the treatment, patients and therapists were aware of the group assignment, and only the statistician would be unaware of the group assignment. N/A Atrial fibrillation. Intervention 1: Intervention group 1: Atrial fibrillation (AF)-specific exposure-based cognitive behavioral therapy will be delivered entirely over the Internet using a secure, personalized web-based platform. The intervention will be therapist-led, will last 10 weeks, and will consist of 5 interactive modules with weekly assignments to be completed in the first 5 weeks. The modules will be downloadable as PDF files. After completing the fifth module, participants will continue to work with the treatment content for the remaining 5 weeks and will submit weekly reports of their exposure exercises to the therapist. Participants will be asked to spend approximately 30–60 min per day studying and practicing the treatment content. The treatment will primarily address two processes that perpetuate disability in atrial fibrillation (30, 41): hypervigilance and fear of AF symptoms, and avoidance of physical and social activities. Treatment interventions will include: education about atrial fibrillation (pathophysiology and drug therapy) and heightened attention to symptoms; self-monitoring practice (awareness of current cardiac symptoms, thoughts, feelings, and behavioral motivations) to reduce the negative value of symptoms; exposure to physical sensations similar to AF symptoms by performing a series of physical exercises, such as walking up and down stairs to increase heart rate or inducing dizziness or shortness of breath with hyperventilation, to reduce fear and hypervigilance of symptoms; exposure to real-life situations with conditions or activities that are usually avoided (such as participating in a social activity while experiencing cardiac symptoms); reduction or elimination of behaviors such as delaying pulse checking that would be used to control symptoms. Behavioral activation, which is encouraging patients to take action toward important life goals that are disrupted by AF; focus on preventing relapse and managing potential progression. Intervention 2: Intervention group 2: The SMART program is a structured psycho-educational intervention that teaches participants a variety of skills to cope more effectively with stress and reduce its negative effects on health. The program includes training in mind-body skills (meditation techniques, brief relaxations, mindfulness, and yoga), stress awareness tools, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive restructuring and adaptive coping skills (modeled after cognitive-behavioral therapy, acceptance and commitment therapy, and positive psychology). The program will meet once a week for 1.5 hours for eight weeks and will include lecture segments, experiential exercises, and small group activities. As part of the program, participants will receive a workbook and audio-guided meditation files and will be encouraged to practice for 10–20 minutes daily and keep a daily journal of their practices (37). Although many of the tools learned in the program are designed to be integrated into daily life, participants are asked to use one of the program’s brief relaxations if they experience cardiac symptoms (such as palpitations) as a way to reduce automatic dissonance and associated anxiety. All SMART group sessions will be held online via a secure, approved videoconferencing platform that allows for encrypted transmission of audio and video, and will be led by a faculty member experienced in leading these groups. Sessions will be held in the evenings on weekdays. The study’s research coordinator will assist each participant in installing the required software and familiarizing them with how to connect and use the virtual environment prior to the first session. Intervention 3: Control group: The control group will receive the same routine training as each center, which includes patient education by nurses, educational pamphlets, and educational follow-ups by the ward nurse. 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 No more information available.
public Neda Sanaie
Valiasr St., Niayesh Insersection, Nursing and Midwifery Faculty
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 nedasanaie@ymail.com Shahid Beheshti University of Medical Sciences scientific Neda Sanaie
Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 nedasanaie@ymail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 years or older. Diagnosis of atrial fibrillation based on ECG CHA₂DS₂-VASc score of 1 or greater in men and 2 or greater in women. 18 years no limit Both Patients with severe complications of their current disease atrial fibrillation immediately after thoracic surgery acute pulmonary embolism known hyperthyroidism malignant disease with a prognosis of survival of less than one year or a diagnosis of terminal illness cognitive impairment and psychiatric disorder receiving regular psychotherapy for a psychiatric disorder participation in another study. N/A N/A N/A Intervention group 1: Atrial fibrillation (AF)-specific exposure-based cognitive behavioral therapy will be delivered entirely over the Internet using a secure, personalized web-based platform. The intervention will be therapist-led, will last 10 weeks, and will consist of 5 interactive modules with weekly assignments to be completed in the first 5 weeks. The modules will be downloadable as PDF files. After completing the fifth module, participants will continue to work with the treatment content for the remaining 5 weeks and will submit weekly reports of their exposure exercises to the therapist. Participants will be asked to spend approximately 30–60 min per day studying and practicing the treatment content. The treatment will primarily address two processes that perpetuate disability in atrial fibrillation (30, 41): hypervigilance and fear of AF symptoms, and avoidance of physical and social activities. Treatment interventions will include: education about atrial fibrillation (pathophysiology and drug therapy) and heightened attention to symptoms; self-monitoring practice (awareness of current cardiac symptoms, thoughts, feelings, and behavioral motivations) to reduce the negative value of symptoms; exposure to physical sensations similar to AF symptoms by performing a series of physical exercises, such as walking up and down stairs to increase heart rate or inducing dizziness or shortness of breath with hyperventilation, to reduce fear and hypervigilance of symptoms; exposure to real-life situations with conditions or activities that are usually avoided (such as participating in a social activity while experiencing cardiac symptoms); reduction or elimination of behaviors such as delaying pulse checking that would be used to control symptoms. Behavioral activation, which is encouraging patients to take action toward important life goals that are disrupted by AF; focus on preventing relapse and managing potential progression. Intervention group 2: The SMART program is a structured psycho-educational intervention that teaches participants a variety of skills to cope more effectively with stress and reduce its negative effects on health. The program includes training in mind-body skills (meditation techniques, brief relaxations, mindfulness, and yoga), stress awareness tools, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive restructuring and adaptive coping skills (modeled after cognitive-behavioral therapy, acceptance and commitment therapy, and positive psychology). The program will meet once a week for 1.5 hours for eight weeks and will include lecture segments, experiential exercises, and small group activities. As part of the program, participants will receive a workbook and audio-guided meditation files and will be encouraged to practice for 10–20 minutes daily and keep a daily journal of their practices (37). Although many of the tools learned in the program are designed to be integrated into daily life, participants are asked to use one of the program’s brief relaxations if they experience cardiac symptoms (such as palpitations) as a way to reduce automatic dissonance and associated anxiety. All SMART group sessions will be held online via a secure, approved videoconferencing platform that allows for encrypted transmission of audio and video, and will be led by a faculty member experienced in leading these groups. Sessions will be held in the evenings on weekdays. The study’s research coordinator will assist each participant in installing the required software and familiarizing them with how to connect and use the virtual environment prior to the first session. Control group: The control group will receive the same routine training as each center, which includes patient education by nurses, educational pamphlets, and educational follow-ups by the ward nurse. Perceived stress: In this study, perceived stress refers to the score obtained from perceived stress. Timepoint: Before and immediately after the intervention and 3 months after the intervention. Method of measurement: PSS-10 – Perceived Stress Scale. Atrial fibrillation-specific quality of life: In this study, atrial fibrillation-related quality of life refers to the average score obtained from the Atrial Fibrillation Impact on Quality of Life Questionnaire. Timepoint: Before and immediately after the intervention and 3 months after the intervention. Method of measurement: AFEQT – Atrial Fibrillation Effect on Quality-of-Life. Sleep Quality. Timepoint: Before and immediately after the intervention and 3 months after the intervention. Method of measurement: PSQI – Pittsburgh Sleep Quality Index. Psychological resilience. Timepoint: Before and immediately after the intervention and 3 months after the intervention. Method of measurement: CD-RISC – Connor-Davidson Resilience Scale. Shahid Beheshti University of Medical Sciences Approved 2025-07-21 Faculties of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of Medical Sciences Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital Tehran Tehran Iran (Islamic Republic of)