Digital Cognitive Behavioral Therapy for Cardiac Anxiety Following Acute Coronary Syndrome: a Randomized Controlled Trial Comparing CBT to a Digital Lifestyle Intervention
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Karolinska Institutet
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Cardiac anxiety questionnaire modified for weekly assessment
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.
Detailed Description
ACS is a leading global cause of mortality and health-related losses. Following ACS, many individuals exhibit symptoms of anxiety and depression, recognized risk factors for recurrent cardiovascular events. Specifically, anxiety related to cardiac symptoms and avoidance behavior, known as cardiac anxiety, has been shown to increase the long-term risk of adverse cardiac events. The purpose of the present interdisciplinary research project is to develop and evaluate an online CBT protocol tailored for ACS patients. This project comprises a series of clinical studies aimed at accumulating knowledge about the most effective ways to treat ACS patients with CBT over the internet. The aim of this study is to assess whether internet-based CBT, following ACS, reduces cardiac anxiety and improves QoL, while controlling for caregiver attention and expectancy of improvement using an active control group. Method: A randomized controlled trial is conducted where participants are randomly assigned to either internet-based CBT (N= 88) or internet-based cardiac lifestyle intervention (internet-CL) (N= 88). The active control group receives internet-CL, focusing on lifestyle modification and health-promoting behaviors. Weekly therapist support through online written communication is provided to participants in both groups. Both treatment are conducted over 8-weeks and are comparable in terms of the number of treatment modules, intensity, and attention from the treating psychologist.
Investigators
Josefin Särnholm
PhD, Lic. Psychologist
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •ACS ≥ 6 months before assessment (type 1 MI STEMI/NSTEMI or unstable angina \[UA\])
- •Age 18 and older
- •Clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (Cardiac Anxiety Questionnaire; CAQ: ≥18
- •Able to read and write in Swedish
Exclusion Criteria
- •Heart failure New York heart Association class IV or ejection fraction ≤ 30%
- •Significant valvular disease
- •Planned coronary artery bypass surgery or percutaneous interventions
- •Any medical restriction to physical exercise
- •Severe medical illness or an acute health threatening disease (e.g., cancer)
- •Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
- •Severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide
- •Alcohol or substance use disorder that would impede ability to complete study protocol
- •Ongoing psychological treatment
Outcomes
Primary Outcomes
Cardiac anxiety questionnaire modified for weekly assessment
Time Frame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Secondary Outcomes
- DOSE Non-Adherence questionnaire(From baseline to 1 year and 2 months)
- Cardiac anxiety questionnaire(From baseline to 1 year and 2 months)
- HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment(Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment)
- HeartQoL Health-related Quality of Life Questionnaire(From baseline to 1 year and 2 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment(From baseline to 8 weeks)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(From baseline to 1 year and 2 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(From baseline to 1 year and 2 months)
- Behaviors following cardiac event questionnaire (BCEQ)(From baseline to 1 year and 2 months)
- Perceived stress scale 4-item(Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment)
- Short Fatigue questionnaire(Baseline to 1 year and 2 months)
- Patient Health Questionnaire-9(From Baseline to 1 year and 2 months)
- Insomnia Severity Index(From Baseline to 1 year and 2 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 1 year and 2 months)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 1 year and 2 months)
- Aversive cognition to medication(Baseline to 8 weeks)
- Adversive cognition to medication(Baseline to 1 year and 2 months)