Digital CBT for Anxiety in Cardiovascular Disease Patients

Overseen By Marie Parsons, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Must not be taking: Psychotropics

Disqualifiers: Schizophrenia, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

95 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have started or changed the dosage of any psychotropic medications (medications that affect your mood, thoughts, or behavior) in the past 4 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment Daylight dCBT Application for anxiety in cardiovascular disease patients?

Research shows that digital cognitive behavioral therapy (dCBT) can help reduce anxiety and worry in patients with cardiovascular disease, which may improve their overall heart health. Additionally, digital CBT has been effective in reducing symptoms of anxiety and depression in other health conditions, suggesting it could be beneficial for cardiovascular patients as well. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy (dCBT) safe for humans?

Digital cognitive behavioral therapy (dCBT) has been used for over a decade and is generally considered safe for humans, with studies showing it as an acceptable treatment for conditions like insomnia, depression, and anxiety in various populations. ^{1 5 6 7 8}

How is the Daylight dCBT Application treatment different from other treatments for anxiety in cardiovascular disease patients?

The Daylight dCBT Application is unique because it offers a digital, scalable, and affordable way to address anxiety in cardiovascular disease patients, who often face barriers to in-person therapy. Unlike traditional treatments, this digital cognitive behavioral therapy (dCBT) can be accessed remotely, making it more accessible and convenient for patients. ^{1 2 3 4 9}

Eligibility Criteria

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.

Inclusion Criteria

Age 18 or older.

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 fibrillation, and other arrhythmias)

Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Study

Open study of the acceptability of the digital intervention with a small group of participants

3 weeks

1 visit (virtual)

Treatment

Participants are randomized to receive digital CBT or placed on a waitlist control condition

10 weeks

4 assessments (virtual) at Week 0, Week 3, Week 6, and Week 10

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Daylight dCBT Application

Trial Overview 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.

Participant Groups

Group I: Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder Experimental Treatment 1 Intervention

Group II: Waitlist Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Findings from Research

The internet-based cognitive behavior therapy (iCBT) program significantly reduced symptoms of distress disorder in cardiovascular disease (CVD) patients compared to an online discussion forum, with improvements noted at both 6- and 12-month follow-ups.

While the iCBT program also helped reduce avoidance behaviors related to fear disorder, it was less effective for other fear symptoms, indicating that the program primarily targeted distress rather than fear-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of internet-based cognitive behavior therapy for depression in cardiovascular disease on symptoms of anxiety: A secondary analysis of a randomized trial. Westas, M., Mourad, G., Andersson, G., et al.[2023]

This study proposes a digital cognitive behavior therapy (dCBT) intervention aimed at treating generalized anxiety disorder (GAD) in patients who have experienced acute cardiovascular disease (CVD), addressing a significant barrier to in-person treatment.

The randomized clinical trial will assess the effectiveness of dCBT in reducing GAD symptoms and improving cardiac health behaviors in 90 adults, potentially enhancing overall care for CVD patients by targeting anxiety without straining existing medical resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial assessment of the feasibility and efficacy of a scalable digital CBT for generalized anxiety and associated health behaviors in a cardiovascular disease population. Parsons, EM., Hiserodt, M., Otto, MW.[2023]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

The study aimed to test an internet-based cognitive-behavioral therapy (iCBT) intervention for people with coronary artery disease (CAD) and depression, but it faced significant challenges, including an 88% dropout rate and only 18 participants completing the intervention.

Despite low satisfaction levels and no significant improvements in depression or quality of life, the study highlights the need for better strategies to engage and treat individuals with CAD and comorbid depression in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD). Bendig, E., Bauereiß, N., Buntrock, C., et al.[2023]

Digital cognitive behavioral therapy (dCBT) has shown strong evidence for effectively treating insomnia, with significant short-term benefits and lasting effects observed for up to 1.5 years across various populations.

Incorporating personalized guidance into dCBT may enhance its effectiveness, indicating that dCBT is ready for standard healthcare implementation, although further research and innovative methods are needed for optimal application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Delivery of Cognitive Behavioral Therapy for Insomnia. Luik, AI., van der Zweerde, T., van Straten, A., et al.[2020]

The study developed an electronic monitoring tool for adolescents using computerized cognitive behavioral therapy (cCBT), which allows clinicians to track mood, risk, and treatment adherence, based on feedback from 50 clinicians and 29 adolescents in focus groups.

Post-implementation feedback indicated that the e-monitoring tool did not negatively affect the therapeutic relationship, although clinicians required more time for monitoring, and there were suggestions for improving the tool's integration with existing clinical systems and enhancing privacy features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tips and Traps: Lessons From Codesigning a Clinician E-Monitoring Tool for Computerized Cognitive Behavioral Therapy. Sundram, F., Hawken, SJ., Stasiak, K., et al.[2020]

Participants with heart failure and depressive symptoms found web-based cognitive behavioral therapy (wCBT) to be a valuable self-care tool, helping them manage their depressive symptoms despite some challenges.

The study highlighted that while wCBT offered flexibility and a sense of personal control, participants also faced difficulties such as technical problems and the desire for real-time support, indicating a need for balance in the delivery of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experiences of Web-Based Cognitive Behavioral Therapy for Heart Failure and Depression: Qualitative Study. Lundgren, J., Johansson, P., Jaarsma, T., et al.[2022]

Digital cognitive-behavioral therapy (dCBT) showed a slight improvement in depression symptoms immediately after treatment compared to control groups, based on a review of 12 trials involving 1,575 adolescents.

There was no significant increase in suicidal attempts or ideation associated with dCBT, indicating it may be a safe option, although the evidence on safety is limited and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Evidence Review of Digital Cognitive-Behavioral Therapy for Adolescents With Depression. Ivlev, I., Beil, TL., Haynes, JS., et al.[2022]

A 9-week internet-based cognitive behavioral therapy (CBT) program significantly reduced depressive symptoms and increased physical activity in patients with cardiovascular disease compared to an online discussion forum, with improvements noted at the 9-week follow-up (P<0.001 for depression, P=0.02 for physical activity).

The study found a significant correlation between the reduction in depressive symptoms and the increase in physical activity, suggesting that addressing depression is crucial for enhancing physical activity levels in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories and associations between depression and physical activity in patients with cardiovascular disease during participation in an internet-based cognitive behavioural therapy programme. Johansson, P., Svensson, E., Andersson, G., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of internet-based cognitive behavior therapy for depression in cardiovascular disease on symptoms of anxiety: A secondary analysis of a randomized trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Initial assessment of the feasibility and efficacy of a scalable digital CBT for generalized anxiety and associated health behaviors in a cardiovascular disease population. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Digital Delivery of Cognitive Behavioral Therapy for Insomnia. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Tips and Traps: Lessons From Codesigning a Clinician E-Monitoring Tool for Computerized Cognitive Behavioral Therapy. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Patient Experiences of Web-Based Cognitive Behavioral Therapy for Heart Failure and Depression: Qualitative Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Rapid Evidence Review of Digital Cognitive-Behavioral Therapy for Adolescents With Depression. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Trajectories and associations between depression and physical activity in patients with cardiovascular disease during participation in an internet-based cognitive behavioural therapy programme. [2021]