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

NCT04986969 | Completed DMC

• 1 other identifier: AD-2019C3-17982
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Heart Diseases

Keywords

rural; cardiac diseases; depressive symptoms; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Change in intervention effects on depressive symptoms moderated by health literacy

  Baseline, 3, 6, and 12 months

• Compare all-cause hospitalization rates between intervention groups

  3 months

• Compare all-cause hospitalization rates between intervention groups

  6 months

• Compare all-cause hospitalization rates between intervention groups

  12 months

• Compare physical activity levels between groups

  3 months

Study Arms (2)

real-time, face-to-face, video-conferenced CBT (vcCBT)

ACTIVE COMPARATOR

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

self-administered internet-based CBT (iCBT)

ACTIVE COMPARATOR

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

Interventions

Online cognitive behavioral therapy BEHAVIORAL

online cognitive behavioral therapy delivered using one of two active methods

real-time, face-to-face, video-conferenced CBT (vcCBT); self-administered internet-based CBT (iCBT)

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Debra Moser: lead
• University of California, Los Angeles: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• 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.

  PMID: 34910821 DERIVED

MeSH Terms

Conditions

Depression; Heart Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cardiovascular Diseases

Study Officials

• Debra K Moser, PhD, RN

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Active therapy is delivered to patients, thus it is impossible to mask the participant or care provider. The investigators are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Linda C Gill Endowed Chair of Nursing

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 3, 2021
• Study Start: April 15, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Request from the repository.

Locations

US (1)