Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Cardiac Disease (COMBAT-DS)

Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Coronary Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Depressive Symptoms
• Intervention / Treatment: Behavioral: Online cognitive behavioral therapy

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 Type: Interventional
• Enrollment (Actual): 444
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: real-time, face-to-face, video-conferenced CBT (vcCBT); vcCBT is cognitive behavioral therapy that consists of eight face-to-face video-conferencing sessions via tablet computers lasting approximately 45 minutes each.	Behavioral: Online cognitive behavioral therapy; online cognitive behavioral therapy delivered using one of two active methods
Active Comparator: self-administered internet-based CBT (iCBT); iCBT is self-directed cognitive behavioral therapy using an interactive internet program, MoodGYM, which does not include direct interactions with a therapist.	Behavioral: Online cognitive behavioral therapy; online cognitive behavioral therapy delivered using one of two active methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms as a result of intervention effects	Change in levels of depressive symptoms measured using the Patient Health Questionnaire-9, across time and between subjects. The Patient Health Questionnaire-9 is a measure that consists of nine items that correspond to criteria for diagnosing depression. Higher scores indicate greater severity of symptoms. Scores on measure can range from 0-27 with an accepted cut-off of ≥ 10 for moderate symptoms. Reliability and validity of the instrument have been established in a variety of populations, including cardiac patients.	Baseline, 3, 6 and 12 months
Change in intervention effects on depressive symptoms moderated by perceived stigma	The investigators will determine whether perceived stigma moderates intervention effects on depressive symptoms across time. Stigma refers to negative beliefs about a condition and its treatment. Depression-related stigma will be measured using the Depression Stigma Scale. Developed to measure personal stigma related to being treated for depressive symptoms, the measure has been used extensively since its inception. Scores on the 18-item total scale can range from 0-36, and higher scores indicate greater perceptions of stigma. The instrument has well-established reliability and validity, and has been used in rural Kentuckians.	Baseline, 3, 6, and 12 months
Change in intervention effects on depressive symptoms moderated by sex	The investigators will determine whether sex moderates intervention effects on depressive symptoms across time. Sex will be self-described by the patient.	Baseline, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intervention effects on depressive symptoms moderated by health literacy	Determine whether health literacy measured using the Newest Vital Sign moderates intervention effects on change in depressive symptoms. Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. The investigator will assess health literacy using the Newest Vital Sign. This instrument is sensitive, reliable and valid for the assessment of health literacy, and is well-accepted by individuals being screened even when they have low educational level.	Baseline, 3, 6, and 12 months
Compare all-cause hospitalization rates between intervention groups	Measurement of hospitalization rates using the electronic health record and patient interview	3 months
Compare all-cause hospitalization rates between intervention groups	Measurement of hospitalization rates using the electronic health record and patient interview	6 months
Compare all-cause hospitalization rates between intervention groups	Measurement of hospitalization rates using the electronic health record and patient interview	12 months
Compare physical activity levels between groups	Measurement of physical activity levels using actigraphy. Actigraphy is an objective method of obtaining accurate and reproducible activity levels, and advances in the technology have produced an instrument that reliably and validly represents physical activity levels. The investigators use the GT9X-BT Link Bluetooth Activity Monitor (ActiGraph, Pensacola, FL). The Actigraph is an omni-directional accelerometer, which assesses acceleration in multiple directions as opposed to uniaxial accelerometer, which is sensitive to movement only in the vertical axis. The actigraph has a dynamic range of ± 8 g. The Actigraph allows researchers to estimate energy expenditure by quantifying the amount time spent in light [<3 metabolic equivalents (METs)], moderate (3-5.99 METs), and vigorous (≥6 METs) physical activity.	3 months
Compare physical activity levels between groups	Measurement of physical activity levels using actigraphy. Actigraphy is an objective method of obtaining accurate and reproducible activity levels, and advances in the technology have produced an instrument that reliably and validly represents physical activity levels. The investigators use the GT9X-BT Link Bluetooth Activity Monitor (ActiGraph, Pensacola, FL). The Actigraph is an omni-directional accelerometer, which assesses acceleration in multiple directions as opposed to uniaxial accelerometer, which is sensitive to movement only in the vertical axis. The actigraph has a dynamic range of ± 8 g. The Actigraph allows researchers to estimate energy expenditure by quantifying the amount time spent in light [<3 metabolic equivalents (METs)], moderate (3-5.99 METs), and vigorous (≥6 METs) physical activity.	6 months
Compare physical activity levels between groups	Measurement of physical activity levels using actigraphy. Actigraphy is an objective method of obtaining accurate and reproducible activity levels, and advances in the technology have produced an instrument that reliably and validly represents physical activity levels. The investigators use the GT9X-BT Link Bluetooth Activity Monitor (ActiGraph, Pensacola, FL). The Actigraph is an omni-directional accelerometer, which assesses acceleration in multiple directions as opposed to uniaxial accelerometer, which is sensitive to movement only in the vertical axis. The actigraph has a dynamic range of ± 8 g. The Actigraph allows researchers to estimate energy expenditure by quantifying the amount time spent in light [<3 metabolic equivalents (METs)], moderate (3-5.99 METs), and vigorous (≥6 METs) physical activity.	12 months
Compare medication adherence between groups	Measurement of medication adherence will be done using the Medication Event Monitoring System. Medication adherence will be measured with the Medication Event Monitoring System (MEMS; AARDEX, Union City, CA), a reliable, accurate and objective method. The MEMS is considered the gold standard in medication adherence measurement. The MEMS offers the advantage of objective measurement and has been successfully used in multiple clinical trials by our group.	3 months
Compare medication adherence between groups	Measurement of medication adherence will be done using the Medication Event Monitoring System. Medication adherence will be measured with the Medication Event Monitoring System (MEMS; AARDEX, Union City, CA), a reliable, accurate and objective method. The MEMS is considered the gold standard in medication adherence measurement. The MEMS offers the advantage of objective measurement and has been successfully used in multiple clinical trials by our group.	6 months
Compare medication adherence between groups	Measurement of medication adherence will be done using the Medication Event Monitoring System. Medication adherence will be measured with the Medication Event Monitoring System (MEMS; AARDEX, Union City, CA), a reliable, accurate and objective method. The MEMS is considered the gold standard in medication adherence measurement. The MEMS offers the advantage of objective measurement and has been successfully used in multiple clinical trials by our group.	12 months
Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety	Measured using interviews for dietary recall	Baseline
Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety	Measured using interviews for dietary recall	3 months
Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety	Measured using interviews for dietary recall	6 months
Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety	Measured using interviews for dietary recall	12 months

Collaborators and Investigators

• Sponsor: Debra Moser
• Collaborators: Patient-Centered Outcomes Research Institute; University of California, Los Angeles
• Investigators: Principal Investigator: Debra K Moser, PhD, RN, University Of Kentucky

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; rural; depressive symptoms; cardiac diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Behavioral Symptoms; Depression; Heart Diseases
• Other Study ID Numbers: AD-2019C3-17982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will use the PCORI-prescribed methods for data-sharing. Deidentified data including the major primary outcome data will be made available.
• IPD Sharing Time Frame: Data will be available 12 months after the end of the study. It will be available in the University of Michigan data repository (per PCORI) forever.
• IPD Sharing Access Criteria: Request from the repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No