Back to resultsEffects of Cognitive Behavior Therapy on Quality of Life in Paroxysmal Atrial Fibrillation Patients
Primary Purpose
CBT
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cognitive Behaviour Therapy
Sponsored by
About this trial
This is an interventional treatment trial for CBT
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.
Sites / Locations
- Minjie Zheng
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CBT group
Treatment as usual (TAU) group
Arm Description
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.
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 Outcome Measures
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
Secondary Outcome Measures
Brief Illness Perception Questionnaire (BIPQ)
The Brief Illness Perception Questionnaire (BIPQ) is a nine-item questionnaire that assesses how people feel about illnesses across nine categories. The individual nine domain scores were added together to create a composite BIPQ score. A higher BIPQ score suggests that the psychological burden of illness is greater (range: 0-80). The BIPQ assesses the following illness perception domains: identity (symptoms experienced); timeline-acute/chronic (perception of the length of disease); consequences (effect of disease on one's life); personal control (control over disease); treatment control (perception of treatment impact); emotional representations (emotional effect of the disease); illness coherence (understanding of disease); illness concern (concern about the disease); and cause (perceived cause of disease). The cause item is an open-ended question that asks patients to rank the top three factors they believe caused their disease
University of Toronto Atrial Fibrillation Severity Scale (AFSS)
University of Toronto Atrial Fibrillation Severity Scale (AFSS)-a 14-item disease-specific scale consisting of three parts. Part 1 measures patients with atrial fibrillation overall life satisfaction and frequency, duration of atrial fibrillation attacks, and severity; Part 2 measures patient utilization rates; Part 3 is divided into symptom subscales, including 7 common symptoms of atrial fibrillation (heart palpitations, dyspnea at rest, dyspnea with activity, exercise intolerance, vertigo, fatigue at rest, and chest pain) and the corresponding frequency of attacks. In this study, the symptom part was selected as the AF symptoms measurement.
The Generalized Anxiety Disorder Questionnaire (GAD-7)
The Generalized Anxiety Disorder Questionnaire (GAD- 7) is a 7-item measure of anxiety symptoms, using a four-point Likert-type scale. The GAD-7 asks how often people have suffered from the seven core symptoms of GAD within the last two weeks with the response options being 'not at all', 'on some days', 'on more than half of the days', and 'almost every day' (scored 0-3, with a total score ranging from 0 to 21). A sum score of≥10 indicates clinically relevant anxiety.
The Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a nine-item tool used to measure the severity of depression over the previous 2 weeks (range 0-27). he PHQ-9 was chosen above other depression screening measures because it is easy to administer and outperforms the structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders-IV as the standard criterion.
Full Information
NCT ID
NCT05893615
First Posted
May 26, 2023
Last Updated
June 5, 2023
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05893615
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as usual (TAU) group
Arm Type
No Intervention
Arm Description
Patients in TAU group received optimal medical care according to the current clinical guidelines. Patients in the TAU group did not receive any psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behaviour Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline score of The 12-item Health Survey Short Form (SF-12) at 10 weeks and 6 months
Description
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
Time Frame
Both groups were assessed the SF-12 three times, respectively at baseline, 10 weeks later and 6 month later
Secondary Outcome Measure Information:
Title
Brief Illness Perception Questionnaire (BIPQ)
Description
The Brief Illness Perception Questionnaire (BIPQ) is a nine-item questionnaire that assesses how people feel about illnesses across nine categories. The individual nine domain scores were added together to create a composite BIPQ score. A higher BIPQ score suggests that the psychological burden of illness is greater (range: 0-80). The BIPQ assesses the following illness perception domains: identity (symptoms experienced); timeline-acute/chronic (perception of the length of disease); consequences (effect of disease on one's life); personal control (control over disease); treatment control (perception of treatment impact); emotional representations (emotional effect of the disease); illness coherence (understanding of disease); illness concern (concern about the disease); and cause (perceived cause of disease). The cause item is an open-ended question that asks patients to rank the top three factors they believe caused their disease
Time Frame
Both groups were assessed the BIPQ three times, respectively at baseline, 10 weeks later and 6 month later
Title
University of Toronto Atrial Fibrillation Severity Scale (AFSS)
Description
University of Toronto Atrial Fibrillation Severity Scale (AFSS)-a 14-item disease-specific scale consisting of three parts. Part 1 measures patients with atrial fibrillation overall life satisfaction and frequency, duration of atrial fibrillation attacks, and severity; Part 2 measures patient utilization rates; Part 3 is divided into symptom subscales, including 7 common symptoms of atrial fibrillation (heart palpitations, dyspnea at rest, dyspnea with activity, exercise intolerance, vertigo, fatigue at rest, and chest pain) and the corresponding frequency of attacks. In this study, the symptom part was selected as the AF symptoms measurement.
Time Frame
Both groups were assessed the AFSS symptoms subscale three times, respectively at baseline, 10 weeks later and 6 month later
Title
The Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
The Generalized Anxiety Disorder Questionnaire (GAD- 7) is a 7-item measure of anxiety symptoms, using a four-point Likert-type scale. The GAD-7 asks how often people have suffered from the seven core symptoms of GAD within the last two weeks with the response options being 'not at all', 'on some days', 'on more than half of the days', and 'almost every day' (scored 0-3, with a total score ranging from 0 to 21). A sum score of≥10 indicates clinically relevant anxiety.
Time Frame
Both groups were assessed the GAD-7 three times, respectively at baseline, 10 weeks later and 6 month later
Title
The Patient Health Questionnaire-9 (PHQ-9)
Description
The Patient Health Questionnaire-9 (PHQ-9) is a nine-item tool used to measure the severity of depression over the previous 2 weeks (range 0-27). he PHQ-9 was chosen above other depression screening measures because it is easy to administer and outperforms the structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders-IV as the standard criterion.
Time Frame
Both groups were assessed the PHQ-9 three times, respectively at baseline, 10 weeks later and 6 month later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qu Shan
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minjie Zheng
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Cognitive Behavior Therapy on Quality of Life in Paroxysmal Atrial Fibrillation Patients
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