Clinical trial NCT04986969: Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Cardiac Disease
Official title: Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Heart Diseases
Keywords: rural
cardiac diseases
depressive symptoms
cognitive behavioral therapy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Patient-Centered Outcomes Research Institute
First posted: 2021-08-03
Enrollment: 444
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use a longitudinal, 2-arm randomized, comparative effectiveness trial, stratified by sex. Patients will be randomized to one of two study arms: 1) real-time, face-to-face, video-conferenced CBT (vcCBT) with a trained CBT therapist; or 2) self-administered internet-based CBT (iCBT) via a well-tested online CBT program, MoodGym. Patients will be followed for 12 months from baseline and depressive symptom data collected at 3, 6, and 12 months to characterize intervention response. Participants will be randomized to either vcCBT (n = 150) or iCBT (n = 150) arm.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* at least moderate depressive symptoms (PHQ-9 ≥ 10)
* rural dwelling
* has had physician-documented acute coronary syndrome (ACS) event

Exclusion Criteria:

* cognitive impairment
* major psychiatric comorbidities, which might require additional treatment
* presence of non-CHD conditions likely to be fatal within next year.

Primary outcomes:
measure: Change in depressive symptoms as a result of intervention effects
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in intervention effects on depressive symptoms moderated by perceived stigma
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in intervention effects on depressive symptoms moderated by sex
timeFrame: Baseline, 3, 6, and 12 months
Secondary outcomes:
measure: Change in intervention effects on depressive symptoms moderated by health literacy
timeFrame: Baseline, 3, 6, and 12 months
measure: Compare all-cause hospitalization rates between intervention groups
timeFrame: 3 months
measure: Compare all-cause hospitalization rates between intervention groups
timeFrame: 6 months
measure: Compare all-cause hospitalization rates between intervention groups
timeFrame: 12 months
measure: Compare physical activity levels between groups
timeFrame: 3 months
measure: Compare physical activity levels between groups
timeFrame: 6 months
measure: Compare physical activity levels between groups
timeFrame: 12 months
measure: Compare medication adherence between groups
timeFrame: 3 months
measure: Compare medication adherence between groups
timeFrame: 6 months
measure: Compare medication adherence between groups
timeFrame: 12 months
measure: Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety
timeFrame: Baseline
measure: Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety
timeFrame: 3 months
measure: Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety
timeFrame: 6 months
measure: Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety
timeFrame: 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Debra K Moser, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4.