Effects of Cognitive Behavior Therapy on Quality of Life in Paroxysmal Atrial Fibrillation Patients

NCT ID: NCT05893615

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-12-31

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.

Conditions

CBT

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behaviour Therapy

Intervention Type: BEHAVIORAL

The CBT module was adjusted as follows: (1) Health education about paroxysmal atrial fibrillation; (2) Self-awareness training; (3) Exposure training; (4) Habitual reversal training；(5) Correcting cognitive distortion; (6) Behavioral activation (7) Specific training for anxiety; (8) Practice and feedback; (9) Relapse prevention; (10) Review.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behaviour Therapy

The CBT module was adjusted as follows: (1) Health education about paroxysmal atrial fibrillation; (2) Self-awareness training; (3) Exposure training; (4) Habitual reversal training；(5) Correcting cognitive distortion; (6) Behavioral activation (7) Specific training for anxiety; (8) Practice and feedback; (9) Relapse prevention; (10) Review.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qu Shan

Head of the Department of Medical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qu Shan

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Minjie Zheng

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

AF-CBT-HRQoL2020

Identifier Type: -

Identifier Source: org_study_id