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Cognitive Behavioral Therapy
Digital CBT for Anxiety in Cardiovascular Disease Patients
N/A
Recruiting
Research Sponsored by Boston University Charles River Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 6, and week 10 (post-treatment)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether digital cognitive behavioral therapy (dCBT) is an acceptable treatment for generalized anxiety disorder (GAD) in people with cardiovascular disease (CVD), and whether it is better than a waitlist control condition.
Who is the study for?
This trial is for adults over 18 who've had a recent acute cardiovascular event like a heart attack or stroke and are experiencing anxiety. They must be past the initial recovery phase, which means at least 2 months since their cardiac event, and have clinical levels of generalized anxiety.
What is being tested?
The study is testing a digital Cognitive Behavioral Therapy (dCBT) app called Daylight to see if it helps people with heart disease manage anxiety and improve health behaviors. Participants will either use the dCBT app or be put on a waitlist as part of the control group.
What are the potential side effects?
Since this intervention involves digital therapy rather than medication, traditional side effects are not expected. However, users may experience discomfort or emotional distress when confronting anxious thoughts during therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, week 6, and week 10 (post-treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 6, and week 10 (post-treatment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Anxiety Sensitivity Inventory (ASI-3)
Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)
Center for Epidemiological Studies Depression Scale 10 Item Version
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety DisorderExperimental Treatment1 Intervention
Group II: Waitlist ControlActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Boston University Charles River CampusLead Sponsor
123 Previous Clinical Trials
13,962 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control
- Group 2: Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT04895995 — N/A