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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

COMBAT-DS Trial 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.Check my eligibility
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.See study design
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.

COMBAT-DS Trial 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.

COMBAT-DS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

COMBAT-DS 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.

Find a Location

Who is running the clinical trial?

University of KentuckyLead Sponsor
186 Previous Clinical Trials
226,184 Total Patients Enrolled
University of California, Los AngelesOTHER
1,531 Previous Clinical Trials
10,264,688 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,996,958 Total Patients Enrolled

Media Library

Online Cognitive Behavioral Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04986969 — N/A
Heart Disease Research Study Groups: real-time, face-to-face, video-conferenced CBT (vcCBT), self-administered internet-based CBT (iCBT)
Heart Disease Clinical Trial 2023: Online Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT04986969 — N/A
Online Cognitive Behavioral Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04986969 — N/A
Heart Disease Patient Testimony for trial: Trial Name: NCT04986969 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have registered for this trial thus far?

"Indeed, according to the official data on clinicaltrials.gov, this trial is currently seeking 500 individuals at one site. This medical experiment was initially posted on April 15th 2021 and most recently updated on September 12th 2022."

Answered by AI

Is this research accessible to those over 80 years of age?

"To be eligible for this medical trial, participants need to fall in the age range of 21 to 110. There are 257 studies available for individuals younger than 18 and 1,098 studies offering treatments for people older than 65 years old."

Answered by AI

Has recruitment for this research study completed or are there still opportunities to participate?

"Yes, the information hosted on clinicaltrials.gov indicates that this study is actively seeking participants and has been since April 15th 2021. The research team aims to recruit 500 individuals from one site by September 12th 2022."

Answered by AI

Who has been deemed eligible to participate in this research endeavor?

"This investigation will enroll 500 individuals suffering from cardiac conditions, ranging in age between 21 and 110. Participants must display moderate depressive symptoms (PHQ-9 ≥ 10), have experienced an ACS incident confirmed by a doctor, and reside in a rural area."

Answered by AI

What is the primary aim of this investigation?

"The primary aim of this medical trial, monitored at Baseline, 3 months, 6 months and 12 months is to observe the alteration in depressive symptoms due to intervention. Secondary objectives include comparison of all-cause hospitalization rates between treatment groups (determined by electronic health record and patient interview), evaluation of medication adherence between cohorts using the Medication Event Monitoring System (MEMS; AARDEX) - a reliable means for assessing medication adhesion - as well as determining if health literacy moderated by Newest Vital Sign moderates transformation in depressive symptoms. Health literacy is defined as an individual's capacity to access, comprehend and digest essential health information needed"

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

I am interested in learning about my body and mind. It would be nice to find something that would help me.
PatientReceived 2+ prior treatments
I have depression and havent found anything that works. I have tried multiple medications that didn't help. I hope this will.
PatientReceived no prior treatments
I have tried medications for years but I still suffer with depression.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many times would I need to travel? Is it compensated? Is medication involved?
PatientReceived 1 prior treatment
How often do I need to travel? What will I get paid? How long do to visits take and how often are the visits?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Kentucky: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients With Cardiac Disease
Debra Moser 2021. "Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients With Cardiac Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04986969.
All > Depression Cincinnati
~61 spots leftby Oct 2024
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