Clinical trial NCT06298864: Internet-based Behavioral Intervention Following ACS
Official title: Internet-based Behavioral Intervention Following Acute Coronary Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Online CBT Targeting Cardiac Anxiety
Keywords: Cardiac Anxiety
Acute Coronary Syndrome
ACS
Internet-CBT
CBT
Secondary prevention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2024-03-07
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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=130) or internet-based cardiac lifestyle intervention (internet-CL) (N=130). 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.

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

Primary outcomes:
measure: Cardiac anxiety questionnaire modified for weekly assessment
timeFrame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]
Secondary outcomes:
measure: Cardiac anxiety questionnaire
timeFrame: From baseline to 8 months
measure: Cardiac anxiety questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment
timeFrame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: HeartQoL Health-related Quality of Life Questionnaire
timeFrame: From baseline to 8 months
measure: HeartQoL Health-related Quality of Life Questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment
timeFrame: From baseline to 8 weeks
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: From baseline to 8 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: From baseline to 1 year and 2 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: Baseline to 8 weeks
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: From baseline to 8 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: From baseline to 1 year and 2 months
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 8 weeks
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 8 months
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: DOSE Non-Adherence questionnaire
timeFrame: From baseline to 8 weeks
measure: DOSE Non-Adherence questionnaire
timeFrame: From baseline to 8 months
measure: DOSE Non-Adherence questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 8 weeks
measure: Perceived stress scale 4-item
timeFrame: Baseline to 8 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 1 year and 2 months
measure: Short Fatigue questionnaire
timeFrame: From baseline to 8 weeks
measure: Short Fatigue questionnaire
timeFrame: Baseline to 8 months
measure: Short Fatigue questionnaire
timeFrame: Baseline to 1 year and 2 months
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 8 weeks
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 8 months
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 1 year and 2 months
measure: Insomnia Severity Index
timeFrame: From Baseline to 8 weeks
measure: Insomnia Severity Index
timeFrame: From Baseline to 8 months
measure: Insomnia Severity Index
timeFrame: From Baseline to 1 year and 2 months
measure: Perceived stress scale 4-item
timeFrame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 8 weeks
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 8 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 1 year and 2 months
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 8 weeks
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 8 months
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 1 year and 2 months
measure: Aversive cognition to medication
timeFrame: Baseline to 8 weeks
measure: Adversive cognition to medication
timeFrame: Baseline to 8 months
measure: Adversive cognition to medication
timeFrame: Baseline to 1 year and 2 months
Other outcomes:
measure: Adverse events
timeFrame: Baseline to 8 weeks
measure: Adverse events
timeFrame: Baseline to 8 months
measure: Adverse events
timeFrame: Baseline to 1 year and 2 months
measure: Adverse events
timeFrame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: Accelerometer (Actigraf®)
timeFrame: Baseline to 8 weeks
measure: Accelerometer (Actigraf®)
timeFrame: Baseline to 1 year and 2 months
measure: Swedish Prescribed Drug Register
timeFrame: Retrospective period of 6 months at baseline
measure: Swedish Prescribed Drug Register
timeFrame: Retrospective period from 6 months at 6 month follow up
measure: Swedish Prescribed Drug Register
timeFrame: Retrospective period from 6 months at 12 month follow up
measure: Working Alliance Inventory
timeFrame: 2 weeks from baseline
measure: Treatment Credibility Scale
timeFrame: Measures treatment credibility
measure: Client satisfaction Questionnaire
timeFrame: Baseline to 8 weeks
measure: Follow-up questions on health changes
timeFrame: Baseline to 8 weeks
measure: Follow-up questions on health changes
timeFrame: Baseline to 8 months
measure: Follow-up questions on health changes
timeFrame: Baseline to 1 year and 2 months
measure: AFFS/SCL-4
timeFrame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: MI-behavior Questionnaire
timeFrame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: DOSE Non-Adherence questionnaire
timeFrame: Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: