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

NCT05893615 | Completed

• 1 other identifier: AF-CBT-HRQoL2020
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline score of The 12-item Health Survey Short Form (SF-12) at 10 weeks and 6 months

  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

  Both groups were assessed the SF-12 three times, respectively at baseline, 10 weeks later and 6 month later

Secondary Outcomes (4)

• 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 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

• 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

Study Arms (2)

CBT group

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behaviour Therapy

Treatment as usual (TAU) group

NO INTERVENTION

Patients in TAU group received optimal medical care according to the current clinical guidelines. Patients in the TAU group did not receive any psychotherapy.

Interventions

Cognitive Behaviour Therapy 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.

CBT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Minjie Zheng

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Qu Shan

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Medical Psychology

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 8, 2023
• Study Start: March 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)