Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Psychosocial stressors and changes in physical health |
Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce) |
10 weeks from baseline |
|
| Other |
Psychosocial stressors and changes in physical health |
Participants are asked about their self-perceived health and if they have experienced any stressful event that they believe have affected their health (e.g severe disease, death of close relative, divorce) |
9 months from baseline |
|
| Other |
Background data |
Demographics, list of medications, co-morbidity, smoking history and alcohol consumption |
Baseline |
|
| Other |
Treatment Credibility Scale |
Measures treatment credibility |
2-4 weeks from baseline |
|
| Other |
Working Alliance Inventory |
Measures therapeutic alliance with the psychologist |
2-4 weeks from baseline |
|
| Other |
Changes in medication |
Participants are asked if they have made any changes in medication |
10 weeks from baseline |
|
| Other |
Changes in medication |
Participants are asked if they have made any changes in medication |
9 months from baseline |
|
| Primary |
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment |
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability). |
Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment [PRIMARY ENDPOINT] |
|
| Primary |
Atrial Fibrillation Effect on Quality-of-Life modified for weekly assessment |
The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. Total score ranges from 0 (severe symptoms and disability) to 100 (no symptoms and disability). |
From baseline to 9 months |
|
| Secondary |
Cardiac Anxiety Questionnaire (CAQ) |
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
From baseline to 10 weeks |
|
| Secondary |
Cardiac Anxiety Questionnaire (CAQ) |
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety. |
From baseline to 9 months |
|
| Secondary |
AF-avoidance behavior questionnaire |
Form measuring AF-specific avoidance- and control behaviors, developed by the research group |
From baseline to 10 weeks |
|
| Secondary |
AF-avoidance behavior questionnaire |
Form measuring AF-specific avoidance- and control behaviors, developed by the research group |
From baseline to 9 months |
|
| Secondary |
AF-avoidance behavior questionnaire modified for weekly assessment |
4 items from the AF-avoidance behavior questionnaire |
Change over 11 measurement points measured from baseline and weekly for 10 weeks during treatment |
|
| Secondary |
Short Form Health Survey (SF-12) |
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life |
From baseline to 10 weeks |
|
| Secondary |
Short Form Health Survey (SF-12) |
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life |
From baseline to 9 months |
|
| Secondary |
Atrial Fibrillation Severity Scale (4 items) |
4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking |
From baseline to 10 weeks |
|
| Secondary |
Atrial Fibrillation Severity Scale (4 items) |
4 items from the Atrial Fibrillation Severity Scale, measuring health care seeking |
From baseline to 9 months |
|
| Secondary |
The Godin-Shepard Leisure-Time Physical Activity Questionnaire |
Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. |
From baseline to 10 weeks |
|
| Secondary |
The Godin-Shepard Leisure-Time Physical Activity Questionnaire |
Level of physical activity. The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. |
From baseline to 9 months |
|
| Secondary |
Body Sensation Questionnaire |
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. |
From baseline to 10 weeks |
|
| Secondary |
Body Sensation Questionnaire |
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. |
From baseline to 9 months |
|
| Secondary |
Patient Health Questionnaire-2 |
Short form measuring depression, score ranging 0 to 6 with a higher score indicating higher level of depression. |
From baseline to 10 weeks |
|
| Secondary |
Patient Health Questionnaire-2 |
Short form measuring depression, score ranging 0 to 6 ,with a higher score indicating higher level of depression. |
From baseline to 9 months |
|
| Secondary |
Perceived Stress Scale (4 items version) |
Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress |
From baseline to 10 weeks |
|
| Secondary |
Perceived Stress Scale (4 items version) |
Measures perceived stress, score ranging from 0-16, with a higher score indicating higher level of perceived stress |
From baseline to 9 months |
|
| Secondary |
Generalized Anxiety Disorder-2 (GAD-2) |
General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry. |
From baseline to 10 weeks |
|
| Secondary |
Generalized Anxiety Disorder-2 |
General anxiety, score ranging from 0-6, with a higher score indicating more anxiety and worry. |
From baseline to 9 months |
|
| Secondary |
Insomnia Severity Index (5 items) |
Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia |
From baseline to 10 weeks |
|
| Secondary |
Insomnia Severity Index (5 items) |
Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia |
From Baseline to 9 months |
|
| Secondary |
Perceived Competence Scale |
Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence |
From baseline to 10 weeks |
|
| Secondary |
Perceived Competence Scale |
Perception of AF-specific knowledge and competence, score ranging from 0- 50 with higher score indicating higher perceived competence |
From baseline to 9 months |
|
| Secondary |
Client Satisfaction Questionnaire |
Treatment satisfaction, score ranging from 0-24, with a higher score indicating higher satisfaction with treatment. |
10 weeks from baseline |
|
| Secondary |
Adverse events |
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively'). |
10 weeks from baseline |
|
| Secondary |
Adverse events |
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively'). |
9 months from baseline |
|
| Secondary |
Symptoms Checklist Severity and Frequency Scale (SCL) |
AF-related symptoms |
From baseline to 10 weeks |
|
| Secondary |
Symptoms Checklist Severity and Frequency Scale (SCL) |
AF-related symptoms measured in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms |
From baseline to 9 months |
|
| Secondary |
AFFS/SCL-4 |
4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT |
Weekly from baseline to 10 weeks |
|
| Secondary |
AFFS/SCL-4 |
4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms not specified in AFEQT |
From baseline to 9 months |
|
