Brief Internet-delivered CBT After ACS

Acute Coronary Syndrome Clinical Trial

Official title:

Brief Internet-delivered Exposure-based Therapy to Reduce Post-traumatic Stress Symptoms and Cardiac Anxiety After Acute Coronary Syndrome: a Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05607992
• Other study ID #: P30AG064198
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early after acute coronary syndrome (ACS).

Description:

Acute coronary syndrome (ACS; myocardial infarction (MI) or unstable angina (UA)) is one of the leading causes of mortality and health loss globally. ACS is a stressful and potentially life-threatening cardiovascular event, and many patients develop symptoms of post-traumatic stress (PTSS) and cardiac anxiety post ACS, which have been shown to negatively affect patients' long-term cardiovascular prognosis.The aim of the proposed pilot study is to develop and evaluate a brief internet-delivered exposure-based CBT intervention provided early following ACS to reduce ACS-related PTSS, cardiac anxiety. and increase physical activity and quality of life. Patients with recent ACS (≥ 4 weeks to 6 months) and with elevated PTSS and anxiety will be eligible. After informed consent, patients will be randomized to internet-delivered CBT (N=15) or to a wait-list control group (N=15). The treatment is a 5 week, therapist-guided, internet-delivered intervention which includes imaginal exposure, interoceptive exposure, and exposure in-vivo. Assessments will be conducted at baseline, immediate post-treatment, and 2- and 6- months after treatment. The wait-list will be crossed over to CBT after completion of the 2 month follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• (A) ACS = four weeks to six months before assessment (MI type 1 STEMI/NSTEMI and UA)

• (B) Age 18-80 years

• (C) Symptoms of PTSD and/or cardiac anxiety that leads to distress and/or interferes with daily life (PCL5; = 10, CAQ: =20)

• (D) On standard of care medical treatment for the cardiac condition according to Swedish cardiovascular guidelines

• (E) Ability to read and write in Swedish.

Exclusion Criteria:

• (F) Heart failure with severe systolic dysfunction (ejection fraction = 35%)

• (G) Significant valvular disease

• (H) Planned coronary artery bypass surgery or percutaneous interventions

• (I) Any medical restriction to physical exercise

• (J) Severe uncontrolled medical illness i.e., advanced cancer

• (K) Grade 3 hypertension (i.e., blood pressure = 180 systolic and/or 110 diastolic)

• (L) Severe psychiatric disorder, active suicidal ideations or cognitive impairment that precludes provision of informed consent or study activities

• (M) Alcohol dependency

• (N) Ongoing psychological treatment.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Psychological Trauma
• Syndrome

Intervention

Behavioral:
• Brief exposure-based CBT
The 5-week intervention is psychologist-guided and delivered via text-based interactive online treatment modules, where patients complete weekly homework assignments and have regular online contact with psychologists with training in CBT for cardiac disease. Key components include imaginal exposure of the ACS event, interoceptive exposure through at home physical activity that stimulats the CV system, exposure in-vivo to reduce avoided situations, and activities to enhance physical activity wellbeing. Labeling (i.e., describing cardiac-related symptoms, thoughts, and feelings) will be used continuously during treatment to enhance the effect of exposure.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Columbia University

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 the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').	Baseline to 3 months
Other	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').	Baseline to 7 months
Other	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').	5 measurement points measured from baseline and weekly for 5 weeks during treatment
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 5 measurement points measured from baseline and weekly for 8 weeks during treatment ]
Primary	Seattle Angina Questionnaire	A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.	Baseline to 3 months
Primary	Acceptability: Client satisfaction Questionnaire	Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.	Baseline to 5 weeks
Primary	Percentage of enrolled participants who complete the treatment	Feasibility of the intervention components will be assessed by >60% assessed as treatment completers. Descriptive analysis will also provide number of messages and therapist time.	Baseline to 5 weeks
Primary	Adverse events	Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').	Baseline to 5 weeks
Secondary	Seattle Angina Questionnaire	A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.	Baseline to 5 weeks
Secondary	Seattle Angina Questionnaire	A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.	Baseline to 7 months
Secondary	Seattle Angina Questionnaire	A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.	Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
Secondary	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.	Baseline to 5 weeks
Secondary	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.	Baseline to 3 months
Secondary	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.	Baseline to 7 months
Secondary	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.	Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
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.	Baseline to 5 weeks
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.	Baseline to 3 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.	Baseline to 7 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.	Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
Secondary	Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.	Baseline to 8 weeks.
Secondary	Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.	Baseline to 3 months
Secondary	Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.	Baseline to 7 months
Secondary	Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	Baseline to 8 weeks
Secondary	Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	Baseline to 3 months
Secondary	Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	Baseline to 7 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	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	Baseline to 3 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	Baseline to 7 months
Secondary	12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	Baseline to 5 weeks
Secondary	12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	Baseline to 3 months
Secondary	12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	Baseline to 7 months
Secondary	Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	Baseline to 5 weeks
Secondary	Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	Baseline to 3 months
Secondary	Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	Baseline to 7 months
Secondary	Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	Baseline to 5 weeks.
Secondary	Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	Baseline to 3 months
Secondary	Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	Baseline to 7 months
Secondary	Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Baseline to 5 weeks
Secondary	Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Baseline to 3 months
Secondary	Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Baseline to 7 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 5 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 3 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 7 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)	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)	Baseline to 3 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)	Baseline to 7 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 5 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.	Baseline to 3 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 7 months