Psychological TraumaNCT05607992
Brief Internet-delivered CBT After ACS
A study testing Brief exposure-based CBT in people with Psychological Trauma and Acute Coronary Syndrome, run by Karolinska Institutet at 2 sites in Sweden.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psychological Trauma, Acute Coronary Syndrome
- What is being tested?
- Brief exposure-based CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesSweden
- Study dates
- 18 May 2023to 21 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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)
Show all 9Show fewer
- (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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska University Hospital
Stockholm, 11635
Karolinska Institutet
Stockholm
About this study
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
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).
Read the detailed 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.
- Conditions
- Psychological Trauma, Acute Coronary Syndrome
- Being tested
- Brief exposure-based CBT
- Keywords
- Acute coronary syndrome, Posttraumatic stress disorder, Cardiac anxiety, Cognitive behavioral therapy
- Medical subject headings
- Psychological Trauma, Acute Coronary Syndrome, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief exposure-based CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief exposure-based CBT | Experimental | * Patient education: Common reactions following ACS. The role of PTS, cardiac anxiety and avoidance behavior on quality of life and physical health and health behaviors.
* Labeling i.e., describe cardiac-related symptoms, thoughts, and feelings.
* Imaginal exposure to reduce PTSS: Imaginal processing and revisiting of the memory of the ACS
* Interoceptive exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms.
* Gradual exposure in-vivo to avoided situations, activities and physical activity. Continuously use labeling while conducting exposure exercises.
* Relapse prevention: Prevention of relapse into avoidance behaviors by identifying risk situations and encouragement of maintaining a healthy physically active lifestyle. Receives: Behavioral: Brief exposure-based CBT |
| Waitlist control | No intervention | The waitlist control will be offered an opportunity to participate in the intervention after the 2-month intervention evaluation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Acceptability: Client satisfaction Questionnaire
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Measured: Baseline to 5 weeks
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.
Measured: Baseline to 5 weeks
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').
Measured: Baseline to 5 weeks
Secondary outcomes (41)
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.
Measured: Baseline to 5 weeks
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.
Measured: Baseline to 7 months
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.
Measured: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
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.
Measured: Baseline to 5 weeks
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 7 months
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.
Measured: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
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.
Measured: Baseline to 5 weeks
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 7 months
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.
Measured: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
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.
Measured: Baseline to 8 weeks.
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 7 months
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: Baseline to 8 weeks
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: Baseline to 3 months
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Measured: Baseline to 7 months
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
Measured: Baseline to 8 weeks.
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
Measured: Baseline to 3 months
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
Measured: Baseline to 7 months
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
Measured: Baseline to 5 weeks
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
Measured: Baseline to 3 months
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
Measured: Baseline to 7 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: Baseline to 5 weeks
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: Baseline to 3 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: Baseline to 7 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: Baseline to 5 weeks.
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: Baseline to 3 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: Baseline to 7 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Baseline to 5 weeks
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Baseline to 3 months
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Measured: Baseline to 7 months
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
Measured: Baseline to 5 weeks
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
Measured: Baseline to 3 months
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
Measured: Baseline to 7 months
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)
Measured: Baseline to 8 weeks
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)
Measured: Baseline to 3 months
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)
Measured: Baseline to 7 months
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.
Measured: Baseline to 5 weeks
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start18 May 2023
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Josefin Särnholm, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607992
- Sponsor's protocol ID
- P30AG064198
- Status last verified
- Aug 2024
- First submitted
- 27 Oct 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05607992
- Acronym / sponsor ID
- P30AG064198
- Conditions
- Psychological Trauma, Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, Posttraumatic stress disorder, Cardiac anxiety, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 18 May 2023 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief exposure-based CBT | Experimental | Behavioral: Brief exposure-based CBT* Patient education: Common reactions following ACS. The role of PTS, cardiac anxiety and avoidance behavior on quality of life and physical health and health behaviors. * Labeling i.e., describe cardiac-related symptoms, thoughts, and feelings. * Imaginal exposure to reduce PTSS: Imaginal processing and revisiting of the memory of the ACS * Interoceptive exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. * Gradual exposure in-vivo to avoided situations, activities and physical activity. Continuously use labeling while conducting exposure exercises. * Relapse prevention: Prevention of relapse into avoidance behaviors by identifying risk situations and encouragement of maintaining a healthy physically active lifestyle. |
| Waitlist control | No intervention | –The waitlist control will be offered an opportunity to participate in the intervention after the 2-month intervention evaluation period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (9 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief exposure-based CBTThe 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. | Behavioural | Brief exposure-based CBT |
Primary outcome
Seattle Angina Questionnaire
Time frame: Baseline to 3 months
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.
Acceptability: Client satisfaction Questionnaire
Time frame: Baseline to 5 weeks
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Percentage of enrolled participants who complete the treatment
Time frame: Baseline to 5 weeks
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.
Adverse events
Time frame: Baseline to 5 weeks
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').
41 secondary outcomes
Seattle Angina Questionnaire
Time frame: Baseline to 5 weeks
Seattle Angina Questionnaire
Time frame: Baseline to 7 months
Seattle Angina Questionnaire
Time frame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
Time frame: Baseline to 5 weeks
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
Time frame: Baseline to 3 months
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
Time frame: Baseline to 7 months
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
Time frame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
Cardiac anxiety questionnaire
Time frame: Baseline to 5 weeks
Cardiac anxiety questionnaire
Time frame: Baseline to 3 months
Cardiac anxiety questionnaire
Time frame: Baseline to 7 months
Cardiac anxiety questionnaire
Time frame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
Myocardial infarction behavior questionnaire
Time frame: Baseline to 8 weeks.
Myocardial infarction behavior questionnaire
Time frame: Baseline to 3 months
Myocardial infarction behavior questionnaire
Time frame: Baseline to 7 months
Body Sensation Questionnaire
Time frame: Baseline to 8 weeks
Body Sensation Questionnaire
Time frame: Baseline to 3 months
Body Sensation Questionnaire
Time frame: Baseline to 7 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: Baseline to 8 weeks.
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: Baseline to 3 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: Baseline to 7 months
12-Item Short-Form Health Survey
Time frame: Baseline to 5 weeks
12-Item Short-Form Health Survey
Time frame: Baseline to 3 months
12-Item Short-Form Health Survey
Time frame: Baseline to 7 months
Patient Health Questionnaire-9
Time frame: Baseline to 5 weeks
Patient Health Questionnaire-9
Time frame: Baseline to 3 months
Patient Health Questionnaire-9
Time frame: Baseline to 7 months
Generalized Anxiety Disorder 7-item
Time frame: Baseline to 5 weeks.
Generalized Anxiety Disorder 7-item
Time frame: Baseline to 3 months
Generalized Anxiety Disorder 7-item
Time frame: Baseline to 7 months
Perceived stress scale 4-item
Time frame: Baseline to 5 weeks
Perceived stress scale 4-item
Time frame: Baseline to 3 months
Perceived stress scale 4-item
Time frame: Baseline to 7 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 5 weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 3 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 7 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Time frame: Baseline to 8 weeks
Lifestyle factors: The national Board of health and Welfare questionnaire
Time frame: Baseline to 3 months
Lifestyle factors: The national Board of health and Welfare questionnaire
Time frame: Baseline to 7 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time frame: Baseline to 5 weeks
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief exposure-based CBT in people with Psychological Trauma and Acute Coronary Syndrome, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire (time frame: Baseline to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.