Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation
21. september 2020 oppdatert av: Brjann Ljotsson, Karolinska Institutet
Internet-delivered Cognitive Behavior Therapy for Atrial Fibrillation - a Randomized Controlled Trial
The aim is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF) compared to treatment as usual.
The study will include 120 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
126
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Stockholm, Sverige
- Karolinska Universitetssjukhuset Solna
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Atrial Fibrillation Quality of Life (AFEQT)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Electrocardiography (ECG) measurement
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Self-rated health, 1 item
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: From baseline to 15 months
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Stress reactivity
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From baseline to 15 months
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. januar 2018
Primær fullføring (Faktiske)
20. desember 2019
Studiet fullført (Faktiske)
20. september 2020
Datoer for studieregistrering
Først innsendt
11. desember 2017
Først innsendt som oppfylte QC-kriteriene
18. desember 2017
Først lagt ut (Faktiske)
19. desember 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. september 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. september 2020
Sist bekreftet
1. september 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AF RCT 1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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