Clinical trial NCT05893615: Effects of Cognitive Behavior Therapy on Quality of Life in Paroxysmal Atrial Fibrillation Patients
Official title: Effects of Cognitive Behavior Therapy on Anxiety, Depression, Illness Perception, and Quality of Life in Paroxysmal Atrial Fibrillation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CBT
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Health-Related Quality of Life (HRQoL) was commonly impaired in atrial fibrillation patients. Depression, anxiety, and illness perception are psychological correlates of HRQoL. Our previous study had shown good effects of CBT on the quality of life in AF patients. This study aimed to establish the long-term efficacy of CBT on both psychological distress and HRQoL. Method: The study was a prospective, open study, pseudo-randomization with a pretest-posttest design and a 6-month follow-up. A total of 102 patients with paroxysmal AF were enrolled, and 90 patients were assigned (1:1) to 10 weeks of CBT focused on anxiety symptoms or to treat as usual in the end. Item Short Form Health Survey (SF-12), GAD-7, PHQ-9, University of Toronto Atrial Fibrillation (AFSS), and Brief Illness Perception Questionnaire (BIPQ) were measured as outcomes.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for participation were: (a) age 18-75 years; (b) AF diagnosis, based on a 12-lead ECG and cardiologist-led examination following the 2016 ESC Guidelines for the Management of Atrial Fibrillation5 and (c) paroxysmal AF diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week 18. (d) ability to read and write in Chinese.

Exclusion Criteria:

* (a) severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%); (b)AF soon after thoracic surgery; (c) malignant disease with a 1-year survival rate or a terminal illness diagnosis; (d) a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder);(e) regular psychological therapy with a mental health condition; (f) participation in another study; (g) cognitive impairment interfering with their ability to participate in the study.

Primary outcomes:
measure: Change from baseline score of The 12-item Health Survey Short Form (SF-12) at 10 weeks and 6 months
timeFrame: Both groups were assessed the SF-12 three times, respectively at baseline, 10 weeks later and 6 month later
Secondary outcomes:
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Both groups were assessed the BIPQ three times, respectively at baseline, 10 weeks later and 6 month later
measure: University of Toronto Atrial Fibrillation Severity Scale (AFSS)
timeFrame: Both groups were assessed the AFSS symptoms subscale three times, respectively at baseline, 10 weeks later and 6 month later
measure: The Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Both groups were assessed the GAD-7 three times, respectively at baseline, 10 weeks later and 6 month later
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Both groups were assessed the PHQ-9 three times, respectively at baseline, 10 weeks later and 6 month later
Other outcomes:
Locations:
city: Beijing
country: China
facility: Minjie Zheng
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Qu Shan
role: PRINCIPAL_INVESTIGATOR
References: