Phase 2
Completed N=29
Beating the Blues for Your Heart
Source: ClinicalTrials.gov NCT01605552 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Post-Treatment Brachial Flow-Mediated Dilation (FMD) Adjusted for Pre-Treatment FMD — 4.18; 2.47 % change in brachial diameter — p=.21
Summary
The objective of this clinical trial is to evaluate whether a computerized depression treatment, delivered before the onset of heart disease, reduces the risk of heart disease in the future. Participants in this trial will be primary care patients who are depressed but do not have a history of heart disease. Half of these patients will receive a standard treatment (usual care), and the other half will receive eight weeks of an evidence-based psychological treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment program for depression. To evaluate change in heart disease risk, the investigators will measure the functioning of the arteries using ultrasound before and after the treatment. It is hypothesized that patients who receive Beating the Blues® will show greater improvements in both depression and artery function than patients who receive standard treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Treatment Brachial Flow-Mediated Dilation (FMD) Adjusted for Pre-Treatment FMD |
4.18; 2.47 | .21 |
| SECONDARY Post-Treatment Depressive Symptoms Severity (SCL-20 Score) Adjusted for Pre-Treatment SCL-20 Score |
0.83; 1.44 | .019 sig |
| SECONDARY Post-Treatment C-reactive Protein (CRP) Adjusted for Pre-Treatment CRP |
2.70; 4.71 | .09 |
| SECONDARY Post-Treatment Interleukin-6 (IL-6) Adjusted for Pre-Treatment IL-6 |
3.76; 4.75 | .43 |
Eligibility Criteria
Inclusion Criteria
- Primary care patients
- Age ≥40 years
- Clinically significant depressive symptoms (Patient Health Questionnaire-9 ≥10)
- No history of cardiovascular disease
Exclusion Criteria
- Pregnant women
- A history of chronic disorders (HIV/AIDS, chronic kidney disease, systemic inflammatory disease, or past-year cancer)
- Current use of anticoagulants or vasodilators (antihypertensive and lipid-lowering medications are allowed)
- Current drinking problem
- History of bipolar disorder or psychosis
- Ongoing treatment for depression with a psychiatrist or psychologist/ counselor (antidepressants alone are allowed)
- Severe cognitive impairment
- Acute risk of suicide
- Significant vision or hearing problems
- Individuals who do not read or speak English
Data sourced from ClinicalTrials.gov (NCT01605552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.