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Behavioral Intervention

Online Cognitive Behavioral Therapy for Depression in Heart Disease Patients (COMBAT-DS Trial)

N/A

Recruiting

Led By Debra K Moser, PhD, RN

Research Sponsored by University of Kentucky

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

has had physician-documented acute coronary syndrome (ACS) event

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two types of online cognitive behavioral therapy for people with heart disease and depressive symptoms living in rural areas.

Who is the study for?

This trial is for rural residents with heart disease who also have moderate to severe depression (PHQ-9 score ≥ 10) and a history of acute coronary syndrome. It's not suitable for those with cognitive impairments, major psychiatric conditions needing extra treatment, or life-threatening non-heart diseases expected to be fatal within a year.

What is being tested?

The study tests two types of online cognitive behavioral therapy: one through video calls and another self-guided on the internet, against usual care. The goal is to see which method better reduces depressive symptoms in rural patients with heart disease.

What are the potential side effects?

Online cognitive behavioral therapy generally does not involve physical side effects like medication might. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a heart attack or other heart-related emergency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in depressive symptoms as a result of intervention effects

Change in intervention effects on depressive symptoms moderated by perceived stigma

Change in intervention effects on depressive symptoms moderated by sex

Secondary study objectives

Change in intervention effects on depressive symptoms moderated by health literacy

Compare all-cause hospitalization rates between intervention groups

Compare medication adherence between groups

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: real-time, face-to-face, video-conferenced CBT (vcCBT)Active Control1 Intervention

vcCBT is cognitive behavioral therapy that consists of eight face-to-face video-conferencing sessions via tablet computers lasting approximately 45 minutes each.

Group II: self-administered internet-based CBT (iCBT)Active Control1 Intervention

iCBT is self-directed cognitive behavioral therapy using an interactive internet program, MoodGYM, which does not include direct interactions with a therapist.

0 / 1Eligibility criteria met