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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240205060913N2
Enrollment
141
Registered
2025-07-31
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation.

Interventions

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
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 bre
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. Behavior

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Sanaie

Shahid Beheshti University of Medical Sciences

nedasanaie@ymail.com+98 21 8865 5366

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026