Atrial FibrillationNCT02694276
Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
A study testing Internet-based cognitive behavior therapy in people with Atrial Fibrillation and Arrhythmia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia
- What is being tested?
- Internet-based cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2015to 30 Aug 2018
- 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
- Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb) [31]; B) Age 18-75 years; C) Able to read and write in Swedish.
Who cannot join
- Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); D) Significant valvular disease; E) Other severe medical illness; F) Severe depression or risk of suicide; G) Alcohol dependency. -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Neuroscience, Karolinska Institutet
Stockholm
About this study
The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.
The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.
- Conditions
- Atrial Fibrillation, Arrhythmia
- Being tested
- Internet-based cognitive behavior therapy
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavior therapyBehavioural
The CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that fruitlessly aim to prevent triggering of AF episodes or to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavior therapy | Experimental | 10 sessions of ICBT during 10 weeks. Receives: Behavioral: Internet-based cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Atrial Fibrillation Quality of Life (AFEQT)
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Measured: From baseline to 12 weeks
Change in The Atrial Fibrillation Quality of Life (AFEQT)
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Measured: From baseline to 9 months.
Secondary outcomes (18)
WHODAS 2.0 (12-item version) •
Change in general quality of life
Measured: From baseline to 12 weeks.
WHODAS 2.0 (12-item version) •
Change in general quality of life:
Measured: From baseline to 9 months.
Symptom checklist (SCL)
Change in AF related symptoms:
Measured: From baseline to 12 weeks.
Symptom checklist (SCL)
Change in AF related symptoms:
Measured: From baseline to 9 months.
Atrial Fibrillation Severity Scale
Change in symptomatic burden
Measured: From baseline to 12 weeks.
Atrial Fibrillation Severity Scale
Change in symptomatic burden
Measured: From baseline to 9 months.
Cardiac Anxiety Questionnaire
Change in symptom preoccupation:
Measured: From baseline to 12 weeks.
Cardiac Anxiety Questionnaire
Change in symptom preoccupation
Measured: From baseline to 9 months.
GAD-7
Change in anxiety
Measured: From baseline to 12 weeks.
GAD-7
Change in anxiety
Measured: From baseline to 9 months.
PHQ-9
Change in depression:
Measured: From baseline to 12 weeks.
PHQ-9
Change in depression
Measured: From baseline to 9 months.
Perceived stress scale
Change in stress reactivity
Measured: From baseline to 12 weeks.
Perceived stress scale
Change in stress reactivity
Measured: From baseline to 9 months.
Change in healthcare consumption and work loss: TIC-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Measured: From baseline to 12 weeks.
Change in healthcare consumption and work loss: TIC-P
The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).
Measured: From baseline to 9 months.
Change in symtomatic burden: Holter ECG.
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Measured: From baseline to 12 weeks.
Change in symptomatic burden: Holter ECG.
The patient will undergo a 24 h ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
Measured: From baseline to 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startDec 2015
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brjann Ljotsson, Karolinska Institutet
- Investigators
- Brjánn Ljótsson, PhD, Principal investigator, Karolinska InstitutetFrieder Braunschweig, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694276
- Sponsor's protocol ID
- AF pilot ICBT 2015
- Status last verified
- Aug 2019
- First submitted
- 14 Dec 2015
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sarnholm J, Skuladottir H, Ruck C, Klaveback S, Olafsdottir E, Pedersen SS, Braunschweig F, Ljotsson B. Internet-Delivered Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: Uncontrolled Pilot Trial. JMIR Cardio. 2021 Mar 2;5(1):e24524. doi: 10.2196/24524.
PubMed 33650972
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavior Therapy for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02694276
- Acronym / sponsor ID
- AF pilot ICBT 2015
- Conditions
- Atrial Fibrillation, Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 29 Feb 2016 (estimated)
- 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.
The aim is to evaluate if internet- delivered CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.The study will include 30 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. AF is associated with poor quality of life (QoL) and large costs for society. In a considerable proportion of patients, AF symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. Psychological factors can worsen AF symptoms, and anxiety and depression are common among AF patients. Symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization.
The aim is to evaluate if CBT, based on behavioral activation and exposure principles, improves wellbeing and QoL in symptomatic AF patients.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavior therapy | Experimental | Behavioral: Internet-based cognitive behavior therapy10 sessions of ICBT during 10 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Paroxysmal AF ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. EHRA class ≥ IIb) [31]; B) Age 18-75 years; C) Able to read and write in Swedish.
Key exclusion criteria (1 listed)
- Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); D) Significant valvular disease; E) Other severe medical illness; F) Severe depression or risk of suicide; G) Alcohol dependency. -
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 |
|---|---|---|
| Internet-based cognitive behavior therapyThe CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that fruitlessly aim to prevent triggering of AF episodes or to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. | Behavioural | Internet-based cognitive behavior therapy |
Primary outcome
Change in The Atrial Fibrillation Quality of Life (AFEQT)
Time frame: From baseline to 12 weeks
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
Change in The Atrial Fibrillation Quality of Life (AFEQT)
Time frame: From baseline to 9 months.
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
18 secondary outcomes
WHODAS 2.0 (12-item version) •
Time frame: From baseline to 12 weeks.
WHODAS 2.0 (12-item version) •
Time frame: From baseline to 9 months.
Symptom checklist (SCL)
Time frame: From baseline to 12 weeks.
Symptom checklist (SCL)
Time frame: From baseline to 9 months.
Atrial Fibrillation Severity Scale
Time frame: From baseline to 12 weeks.
Atrial Fibrillation Severity Scale
Time frame: From baseline to 9 months.
Cardiac Anxiety Questionnaire
Time frame: From baseline to 12 weeks.
Cardiac Anxiety Questionnaire
Time frame: From baseline to 9 months.
GAD-7
Time frame: From baseline to 12 weeks.
GAD-7
Time frame: From baseline to 9 months.
PHQ-9
Time frame: From baseline to 12 weeks.
PHQ-9
Time frame: From baseline to 9 months.
Perceived stress scale
Time frame: From baseline to 12 weeks.
Perceived stress scale
Time frame: From baseline to 9 months.
Change in healthcare consumption and work loss: TIC-P
Time frame: From baseline to 12 weeks.
Change in healthcare consumption and work loss: TIC-P
Time frame: From baseline to 9 months.
Change in symtomatic burden: Holter ECG.
Time frame: From baseline to 12 weeks.
Change in symptomatic burden: Holter ECG.
Time frame: From baseline to 9 months.
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 21 Aug 2019.
- Derived from this study: PubMed 33650972Sarnholm J, Skuladottir H, Ruck C, Klaveback S, Olafsdottir E, Pedersen SS, Braunschweig F, Ljotsson B. Internet-Delivered Exposure-Based Therapy for Symptom Preoccupation in Atrial Fibrillation: Uncontrolled Pilot Trial. JMIR Cardio. 2021 Mar 2;5(1):e24524. doi: 10.2196/24524.
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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.
Brjánn Ljótsson, PhD principal investigator
Karolinska Institutet
Frieder Braunschweig, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavior therapy in people with Atrial Fibrillation and Arrhythmia, run by Karolinska Institutet at 1 site in Sweden.
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 21 Aug 2019. 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 Sweden. 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 in The Atrial Fibrillation Quality of Life (AFEQT) (time frame: From baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694276, which also lists 1 linked publication.
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 21 Aug 2019; AzTrials last refreshed its copy on 2 Nov 2026.