- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03378349
Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 more than a wait list offered treatment as usual.
Method: A randomized controlled trial. Participants are randomized to internet-delivered CBT for 10 weeks (N=60) or to treatment as usual (N=60). The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls. Patients on the treatment as usual wait list will be provided standardized written information about basic self-management in AF. The treatment as usual wait list will be crossed over to treatment 3 months after the treatment group has completed treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Karolinska Universitetssjukhuset Solna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria: A) 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) ; B) Age 18-75 years; C) On optimal medical treatment; D). Able to read and write in Swedish.
Exclusion Criteria:
- (E) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); (F) significant valvular disease; (G) planned ablation for AF or ablation within 3 months before assessment; (H) other severe medical illness; (I) any medical restriction to physical exercise; (J) severe psychiatric disorder, severe depression, or risk of suicide; (K) alcohol dependency.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Internet-delivered CBT over 10 weeks
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 aim 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.
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The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention.
Include the guidance of a minimum weekly contact with a CBT psychologist.
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Placebo Comparator: Treatment as usual wait list
Patients randomized to the treatment as usual wait list arm will receive standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health.
Thus, the treatment as usual arm will control for the provision of basic patient information, but without the guidance of a psychologist or any CBT interventions.
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Consist of standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health, without the guidance of a psychologist or any CBT interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Atrial Fibrillation Quality of Life (AFEQT)
Time Frame: From baseline to 6 months PRIMARY ENDPOINT
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 6 months PRIMARY ENDPOINT
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The Atrial Fibrillation Quality of Life (AFEQT)
Time Frame: From baseline to 12 weeks
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 12 weeks
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The Atrial Fibrillation Quality of Life (AFEQT)
Time Frame: From baseline to 9 months
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 9 months
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The Atrial Fibrillation Quality of Life (AFEQT)
Time Frame: From baseline to 15 months
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The AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction.
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From baseline to 15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electrocardiography (ECG) measurement
Time Frame: From baseline to 12 weeks
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Change in symptomatic burden.
The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
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From baseline to 12 weeks
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ECG measurement
Time Frame: From baseline to 6 months
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Change in symptomatic burden.
The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
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From baseline to 6 months
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ECG measurement
Time Frame: From baseline to 15 months
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Change in symptomatic burden.
The patient will undergo 5 days ECG assessment in order to measure objectively symptomatic burden (number and duration of symptomatic AF episodes and symptomatic "non-AF episodes")
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From baseline to 15 months
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Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 12 weeks
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Symptom preoccupation
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From baseline to 12 weeks
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Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 6 months
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Symptom preoccupation
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From baseline to 6 months
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Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 9 months
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Symptom preoccupation
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From baseline to 9 months
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Cardiac Anxiety Questionary (CAQ)
Time Frame: From baseline to 15 months
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Symptom preoccupation
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From baseline to 15 months
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the World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12- item version)
Time Frame: From baseline to 12 weeks
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General quality of life
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From baseline to 12 weeks
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WHODAS 2.0 (12-item version)
Time Frame: From baseline to 6 months
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General quality of life
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From baseline to 6 months
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WHODAS 2.0 (12-item version)
Time Frame: From baseline to 15 months
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General quality of life
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From baseline to 15 months
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Symptom checklist Severity and Frequency Scale (SCL)
Time Frame: From baseline to 12 weeks
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AF related symptoms
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From baseline to 12 weeks
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Symptom checklist Severity and Frequency Scale (SCL)
Time Frame: From baseline to 6 months
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AF related symptoms
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From baseline to 6 months
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Symptom checklist Severity and Frequency Scale (SCL)
Time Frame: From baseline to 15 months
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AF related symptoms
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From baseline to 15 months
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Atrial Fibrillation Severity Scale
Time Frame: From baseline to 12 weeks
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Symptomatic burden
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From baseline to 12 weeks
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Atrial Fibrillation Severity Scale
Time Frame: From baseline to 6 months
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Symptomatic burden
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From baseline to 6 months
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Atrial Fibrillation Severity Scale
Time Frame: From baseline to 15 months
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Symptomatic burden
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From baseline to 15 months
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Patient Health Questionnaire (PHQ-9)
Time Frame: From baseline to 12 weeks
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Depression
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From baseline to 12 weeks
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PHQ-9
Time Frame: From baseline to 6 months
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Depression
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From baseline to 6 months
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PHQ-9
Time Frame: From baseline to 15 months
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Depression
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From baseline to 15 months
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Client satisfaction Questionnaire
Time Frame: From baseline to 12 weeks
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Treatment satisfaction
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From baseline to 12 weeks
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Adverse events
Time Frame: From baseline to 12 weeks
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Potential adverse reactions to the treatment
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From baseline to 12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-rated health, 1 item
Time Frame: From baseline to 12 weeks
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The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
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From baseline to 12 weeks
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Self-rated health, 1 item
Time Frame: From baseline to 6 months
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The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
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From baseline to 6 months
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Self-rated health, 1 item
Time Frame: From baseline to 15 months
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The measure consists of a single item that asks the participants to rate their overall health as excellent, good, fair, or poor.
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From baseline to 15 months
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Healthcare consumption and work loss:Tic-P
Time Frame: From baseline to 12 weeks
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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).
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From baseline to 12 weeks
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Healthcare consumption and work loss:Tic-P
Time Frame: From baseline to 6 months
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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).
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From baseline to 6 months
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Healthcare consumption and work loss:Tic-P
Time Frame: From baseline to 15 months
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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).
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From baseline to 15 months
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The International Physical Activity Questionnaire
Time Frame: From baseline to 6 months
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Physical activity
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From baseline to 6 months
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The International Physical Activity Questionnaire
Time Frame: From baseline to 12 weeks
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Physical activity
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From baseline to 12 weeks
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The International Physical Activity Questionnaire
Time Frame: From baseline to 9 months
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Physical activity
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From baseline to 9 months
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The International Physical Activity Questionnaire
Time Frame: From baseline to 15 months
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Physical activity
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From baseline to 15 months
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Body Sensation Questionnaire
Time Frame: From baseline to 12 weeks
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Fear of bodily sensations
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From baseline to 12 weeks
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Body Sensation Questionnaire
Time Frame: From baseline to 6 months
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Fear of bodily sensations
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From baseline to 6 months
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Body Sensation Questionnaire
Time Frame: From baseline to 15 months
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Fear of bodily sensations
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From baseline to 15 months
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Anxiety Sensitivity Index
Time Frame: From baseline to 12 weeks
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Anxiety sensitivity
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From baseline to 12 weeks
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Anxiety Sensitivity Index
Time Frame: From baseline to 6 months
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Anxiety sensitivity
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From baseline to 6 months
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Anxiety Sensitivity Index
Time Frame: From baseline to 15 months
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Anxiety sensitivity
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From baseline to 15 months
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Accelerometer
Time Frame: From baseline to 12 weeks
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Objective measurement of physical activity 1 week
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From baseline to 12 weeks
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Accelerometer
Time Frame: From baseline to 6 months
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Objective measurement of physical activity 1 week
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From baseline to 6 months
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Accelerometer
Time Frame: From baseline to 15 months
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Objective measurement of physical activity 1 week
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From baseline to 15 months
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Perceived stress scale (4-item version)
Time Frame: From baseline to 12 weeks
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Stress reactivity
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From baseline to 12 weeks
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Perceived stress scale (4-item version)
Time Frame: From baseline to 6 months
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Stress reactivity
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From baseline to 6 months
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Perceived stress scale (4-item version)
Time Frame: From baseline to 9 months
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Stress reactivity
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From baseline to 9 months
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Perceived stress scale (4-item version)
Time Frame: From baseline to 15 months
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Stress reactivity
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From baseline to 15 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF RCT 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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