CBTNCT05893615
Effects of Cognitive Behavior Therapy on Quality of Life in Paroxysmal Atrial Fibrillation Patients
A study testing Cognitive Behaviour Therapy in people with CBT, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CBT
- What is being tested?
- Cognitive Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cognitive Behavior Therapy on Anxiety, Depression, Illness Perception, and Quality of Life in Paroxysmal Atrial Fibrillation Patients
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
- Being tested
- Cognitive Behaviour Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Both groups were assessed the PHQ-9 three times, respectively at baseline, 10 weeks later and 6 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CBTStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qu Shan, Peking University People's Hospital
- Investigators
- Qu Shan, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893615
- Sponsor's protocol ID
- AF-CBT-HRQoL2020
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Behavior Therapy on Anxiety, Depression, Illness Perception, and Quality of Life in Paroxysmal Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT05893615
- Acronym / sponsor ID
- AF-CBT-HRQoL2020
- Conditions
- CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT group | Active comparator | Behavioral: Cognitive Behaviour TherapyPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behaviour TherapyThe 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. | Behavioural | CBT group |
Primary outcome
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
4 secondary outcomes
Brief Illness Perception Questionnaire (BIPQ)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Both groups were assessed the PHQ-9 three times, respectively at baseline, 10 weeks later and 6 month later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qu Shan principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Therapy in people with CBT, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.