Effects of Cognitive Behavior Therapy on Anxiety, Depression, Illness Perception, and Quality of Life in Paroxysmal Atrial Fibrillation Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Change from baseline score of The 12-item Health Survey Short Form (SF-12) at 10 weeks and 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •(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.
Arms & Interventions
CBT group
Patients in the CBT intervention group, who received CBT focused on anxiety symptoms in addition to their usual treatment, including 10 one-hour sessions spread over 10 weeks, and weekly homework guided by the therapist.
Intervention: Cognitive Behaviour Therapy (Behavioral)
Treatment as usual (TAU) group
Patients in TAU group received optimal medical care according to the current clinical guidelines. Patients in the TAU group did not receive any psychotherapy.
Outcomes
Primary Outcomes
Change from baseline score of The 12-item Health Survey Short Form (SF-12) at 10 weeks and 6 months
Time Frame: Both groups were assessed the SF-12 three times, respectively at baseline, 10 weeks later and 6 month later
SF-12 is a 12-item, multipurpose short-form survey that is used to measure generic HRQoL (derived from the SF-36). The findings are weighted and summed to produce interpretable scales for a participant's physical and mental well-being. SF-12 is divided into two domains: the physical component summary (PCS) and the mental component summary (MCS). Each domain scores from 0 to 100, with higher scores indicating a better health status
Secondary Outcomes
- The Generalized Anxiety Disorder Questionnaire (GAD-7)(Both groups were assessed the GAD-7 three times, respectively at baseline, 10 weeks later and 6 month later)
- Brief Illness Perception Questionnaire (BIPQ)(Both groups were assessed the BIPQ three times, respectively at baseline, 10 weeks later and 6 month later)
- University of Toronto Atrial Fibrillation Severity Scale (AFSS)(Both groups were assessed the AFSS symptoms subscale three times, respectively at baseline, 10 weeks later and 6 month later)
- The Patient Health Questionnaire-9 (PHQ-9)(Both groups were assessed the PHQ-9 three times, respectively at baseline, 10 weeks later and 6 month later)
Investigators
Qu Shan
Head of the Department of Medical Psychology
Peking University People's Hospital