Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 5:23 PM
Study NCT ID:
NCT04986969
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Cardiac Disease
Sponsor:
Debra Moser
Organization:
Study Overview
Official Title:
Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Coronary Heart Disease
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMBAT-DS
Brief Summary:
Individuals with heart disease and depressive symptoms suffer from higher death rates, higher rates of acute cardiac events (such as heart attacks), and faster progression of heart disease compared to those with heart disease who do not have depressive symptoms, and these problems are much worse in rural people. Unfortunately, rural people with heart disease and depressive symptoms do not receive needed therapy for depressive symptoms because of lack of mental health providers in rural areas, worries about stigma, and difficulty accessing mental health care because of multiple barriers to traveling to get care. To overcome these barriers, the investigators will compare the impact of two types of online cognitive behavioral therapy (video-conferenced face-to-face versus self-administered internet-based) and usual care on depressive symptoms to provide patients and healthcare providers with needed information about which is more effective and to increase the number of patients adequately treated.
Detailed Description:
Rural areas are noted for marked disparities in mortality, cardiovascular health, and access to health care. Prevalence rates for both coronary heart disease (CHD) and depressive symptoms in rural areas are higher than in urban areas. These facts are important because CHD patients experience high rates of depressive symptoms, which are associated with increased risk of getting and dying from CHD. Unfortunately, rural people with CHD and depressive symptoms do not receive needed therapy for depressive symptoms because of lack of mental health providers in rural areas, worries about stigma leading to treatment avoidance, and difficulty accessing mental health care because of barriers to travel to get care. Cognitive behavioral therapy (CBT), reduces depressive symptoms in CHD patients, but in its traditional form (in-person meetings of patient and therapist), CBT is resource-intensive and inaccessible to most rural patients. Wireless internet technology has the potential to make CBT more user-friendly, and accessible to rural patients. There has been a proliferation of alternative, internet-based, remote-delivery CBT interventions recently. The permutations of remote-delivery CBT fall under two categories - real-time, face-to-face, video-conferenced CBT (vcCBT) and self-administered internet-based CBT (iCBT). It is unclear which category of these delivery modalities is more effective. Determining which treatment option is more effective for treating depressive symptoms in rural patients with CHD and depressive symptoms will identify an easily accessible treatment option for rural patients. Using a randomized, controlled, stratified (by sex) design, the investigators will compare vcCBT, iCBT and usual care in rural CHD patients on the primary outcome of depressive symptoms over time. In addition, the investigators will determine whether intervention adherence, satisfaction or acceptability moderate treatment effects. The investigators will also assess whether sex or stigma moderate intervention effects to determine whether effectiveness of treatment option varies by sex or stigma level. Data about outcomes will be collected at baseline, 3 months, 6 months, and 12 months and provide important information about the trajectory of outcomes. Results from this study will provide new knowledge about which approach to treating depressive symptoms in rural CHD patients is more effective to improve decision-making in patients and healthcare providers, and increase the number of patients properly treated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: