Internet-based Behavioral Intervention Following ACS

Acute Coronary Syndrome Clinical Trial

— ACS-CBT  

Official title:

Internet-based Behavioral Intervention Following Acute Coronary Syndrome: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298864
• Other study ID #: ASC-RCT 2
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: Josefin Särnholm, Lic psychologist, PhD
• Phone: + 46 852483258
• Email: josefin.sarnholm[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Behavioral:
• Internet-CBT
Common reactions following ACS. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation, i.e., labeling. General lifestyle advice on e.g., physical activity, diet. Identifying life areas impaired by ACS-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them. Gradual exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. Gradual exposure to avoided situations, activities and increase in physical activity. Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.
• Internet-CL
Education on ACS, risk factors, its treatments and medication. Education and advice promoting healthy habits regarding diet, alcohol and tobacco. Education and advice regarding physical activity and the beneficial effects on health. Education regarding common emotional reactions following ACS. Prevention of relapse and plan forward to maintain a healthy lifestyle.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate	Baseline to 8 weeks
Other	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate	Baseline to 8 months
Other	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate	Baseline to 1 year and 2 months
Other	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate	Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
Other	Accelerometer (Actigraf®)	n Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week	Baseline to 8 weeks
Other	Accelerometer (Actigraf®)	n Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week	Baseline to 1 year and 2 months
Other	Swedish Prescribed Drug Register	The prescription fill-rate of cardiovascular medication (e.g., statin)will be collected and will be used to calculate the proportion of days covered (PDC) with a statin. A PDC <80% will be used to indicate nonadherence as per convention in other studies of cardiovascular medication refills.	Retrospective period of 6 months at baseline
Other	Swedish Prescribed Drug Register	The prescription fill-rate of cardiovascular medication (e.g., statin)will be collected and will be used to calculate the proportion of days covered (PDC) with a statin. A PDC <80% will be	Retrospective period from 6 months at 6 month follow up
Other	Swedish Prescribed Drug Register	The prescription fill-rate of cardiovascular medication (e.g., statin)will be collected and will be used to calculate the proportion of days covered (PDC) with a statin. A PDC <80% will be	Retrospective period from 6 months at 12 month follow up
Other	Working Alliance Inventory	Measures therapeutic alliance with the psychologist	2 weeks from baseline
Other	Treatment Credibility Scale	2 weeks from baseline	Measures treatment credibility
Other	Client satisfaction Questionnaire	Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.	Baseline to 8 weeks
Other	Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 8 weeks
Other	Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 8 months
Other	Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 1 year and 2 months
Other	AFFS/SCL-4	4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms	Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
Other	MI-behavior Questionnaire	5 items measuring avoidance behavior from the MI-related avoidance questionnaire behaviors developed by the research group	Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
Other	DOSE Non-Adherence questionnaire	3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.	Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
Primary	Cardiac anxiety questionnaire modified for weekly assessment	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment [PRIMARY ENDPOINT]
Secondary	Cardiac anxiety questionnaire	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 8 months
Secondary	Cardiac anxiety questionnaire	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 1 year and 2 months
Secondary	HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment	The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.	Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
Secondary	HeartQoL Health-related Quality of Life Questionnaire	The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.	From baseline to 8 months
Secondary	HeartQoL Health-related Quality of Life Questionnaire	The HeartQoL questionnaire, comprising 14 items, includes a Global scale of 14 items, further divided into Physical (10 items) and Emotional (4 items) subscales. Scores range from 0 to 3, with 3 indicating the highest level and 0 the lowest.	From baseline to 1 year and 2 months
Secondary	Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment	Cardiac-related symptoms 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 8 weeks
Secondary	Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	cardiac-related symptoms 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 8 months
Secondary	Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms 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 1 year and 2 months
Secondary	University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption	Baseline to 8 weeks
Secondary	University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption	From baseline to 8 months
Secondary	University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption	From baseline to 1 year and 2 months
Secondary	Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group	From baseline to 8 weeks
Secondary	Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group	From baseline to 8 months
Secondary	Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group	From baseline to 1 year and 2 months
Secondary	DOSE Non-Adherence questionnaire	3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.	From baseline to 8 weeks
Secondary	DOSE Non-Adherence questionnaire	3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.	From baseline to 8 months
Secondary	DOSE Non-Adherence questionnaire	3 items from this two domain scale measuring medical adherence designed to assess missed doses and reasons for missed doses.	From baseline to 1 year and 2 months
Secondary	Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Baseline to 8 weeks
Secondary	Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Baseline to 8 months
Secondary	Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Baseline to 1 year and 2 months
Secondary	Short Fatigue questionnaire	4-item scale measuring fatigue.	From baseline to 8 weeks
Secondary	Short Fatigue questionnaire	4-item scale measuring fatigue.	Baseline to 8 months
Secondary	Short Fatigue questionnaire	4-item scale measuring fatigue.	Baseline to 1 year and 2 months
Secondary	Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 8 weeks
Secondary	Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 8 months
Secondary	Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 1 year and 2 months
Secondary	Insomnia Severity Index	Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.	From Baseline to 8 weeks
Secondary	Insomnia Severity Index	Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.	From Baseline to 8 months
Secondary	Insomnia Severity Index	Measurement of the degree of sleep difficulties. The total score can range from 0 to 28 points. Higher scores indicate more severe sleep difficulties.	From Baseline to 1 year and 2 months
Secondary	Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Change over 9 measurement points measured from baseline and weekly for 8 weeks during treatment
Secondary	The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 8 weeks
Secondary	The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 8 months
Secondary	The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	Level of physical activity and inactivity: On the Godin leisure-time excercise: 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. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 1 year and 2 months
Secondary	Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 8 weeks
Secondary	Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 8 months
Secondary	Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 1 year and 2 months
Secondary	Aversive cognition to medication	: A 3-item subset of questions with regards to psychological distress associated with cardiac medication	Baseline to 8 weeks
Secondary	Adversive cognition to medication	: A 3-item subset of questions with regards to psychological distress associated with cardiac medication	Baseline to 8 months
Secondary	Adversive cognition to medication	: A 3-item subset of questions with regards to psychological distress associated with cardiac medication	Baseline to 1 year and 2 months