Brief Internet-delivered CBT After ACS

August 26, 2024 updated by: Josefin Särnholm, Karolinska Institutet

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet
      • Stockholm, Sweden, 11635
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Waitlist control
The waitlist control will be offered an opportunity to participate in the intervention after the 2-month intervention evaluation period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 months
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.
Baseline to 5 weeks
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.
Baseline to 5 weeks
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').
Baseline to 5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seattle Angina Questionnaire
Time Frame: Baseline to 5 weeks
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
Seattle Angina Questionnaire
Time Frame: Baseline to 7 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.
Baseline to 7 months
Seattle Angina Questionnaire
Time Frame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
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
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
Time Frame: Baseline to 5 weeks
Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
Baseline to 5 weeks
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
Time Frame: Baseline to 3 months
Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
Baseline to 3 months
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
Time Frame: Baseline to 7 months
Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
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
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
Cardiac anxiety questionnaire
Time Frame: Baseline to 5 weeks
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
Cardiac anxiety questionnaire
Time Frame: Baseline to 3 months
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
Cardiac anxiety questionnaire
Time Frame: Baseline to 7 months
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
Cardiac anxiety questionnaire
Time Frame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
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
Myocardial infarction behavior questionnaire
Time Frame: Baseline to 8 weeks.
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.
Myocardial infarction behavior questionnaire
Time Frame: Baseline to 3 months
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
Myocardial infarction behavior questionnaire
Time Frame: Baseline to 7 months
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
Body Sensation Questionnaire
Time Frame: Baseline to 8 weeks
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Baseline to 8 weeks
Body Sensation Questionnaire
Time Frame: Baseline to 3 months
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Baseline to 3 months
Body Sensation Questionnaire
Time Frame: Baseline to 7 months
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Baseline to 7 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time Frame: Baseline to 8 weeks.
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.
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time Frame: Baseline to 3 months
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
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time Frame: Baseline to 7 months
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
12-Item Short-Form Health Survey
Time Frame: Baseline to 5 weeks
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
12-Item Short-Form Health Survey
Time Frame: Baseline to 3 months
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
12-Item Short-Form Health Survey
Time Frame: Baseline to 7 months
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
Patient Health Questionnaire-9
Time Frame: Baseline to 5 weeks
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Baseline to 5 weeks
Patient Health Questionnaire-9
Time Frame: Baseline to 3 months
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Baseline to 3 months
Patient Health Questionnaire-9
Time Frame: Baseline to 7 months
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Baseline to 7 months
Generalized Anxiety Disorder 7-item
Time Frame: Baseline to 5 weeks.
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Baseline to 5 weeks.
Generalized Anxiety Disorder 7-item
Time Frame: Baseline to 3 months
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Baseline to 3 months
Generalized Anxiety Disorder 7-item
Time Frame: Baseline to 7 months
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Baseline to 7 months
Perceived stress scale 4-item
Time Frame: Baseline to 5 weeks
Stress reactivity. A greater score indicate more perceived stress.
Baseline to 5 weeks
Perceived stress scale 4-item
Time Frame: Baseline to 3 months
Stress reactivity. A greater score indicate more perceived stress.
Baseline to 3 months
Perceived stress scale 4-item
Time Frame: Baseline to 7 months
Stress reactivity. A greater score indicate more perceived stress.
Baseline to 7 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time Frame: Baseline to 5 weeks
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
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time Frame: Baseline to 3 months
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
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time Frame: Baseline to 7 months
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
Lifestyle factors: The national Board of health and Welfare questionnaire
Time Frame: Baseline to 8 weeks
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
Lifestyle factors: The national Board of health and Welfare questionnaire
Time Frame: Baseline to 3 months
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
Lifestyle factors: The national Board of health and Welfare questionnaire
Time Frame: Baseline to 7 months
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
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time Frame: Baseline to 5 weeks
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
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time Frame: Baseline to 3 months
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
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time Frame: Baseline to 7 months
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Baseline to 3 months
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
Adverse events
Time Frame: Baseline to 7 months
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
Adverse events
Time Frame: 5 measurement points measured from baseline and weekly for 5 weeks during treatment
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
AFFS/SCL-4
Time Frame: Change over 5 measurement points measured from baseline and weekly for 8 weeks during treatment ]
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 ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P30AG064198 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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