BridgeMD
Tests treatment safety and results for Anxiety Disorders
Official title Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
ClinicalTrials.gov ID: NCT04895995
What this study is testing
- What it's testing
- The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Experienced an acute CVD event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart...
- Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7
- Age 18 or older.
- Individuals must be in the post-acute phase of their CVD; this is operationalized as \> 2 months post an acute cardiac event.
You likely can't join if
- Non-English speaker/literate
- No access to a digital device
- Severely vision impaired
- Severe cognitive impairment
- Pending acute surgery or with a life prognosis of fewer than 6 months
- The presence [by self-report] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine
See the full eligibility criteria
- Experienced an acute CVD event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart failure with hospitalization; exclusion of coronary heart disease, atrial...
- Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7
- Age 18 or older.
- Individuals must be in the post-acute phase of their CVD; this is operationalized as \> 2 months post an acute cardiac event.
- Non-English speaker/literate
- No access to a digital device
- Severely vision impaired
- Severe cognitive impairment
- Pending acute surgery or with a life prognosis of fewer than 6 months
- The presence [by self-report] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine
- Initiation or change of psychotropic medication dosage within the past 4 weeks
- Received CBT for anxiety in last 3 months
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.