Internet-Delivered Cognitive Behavioural Therapy for Adults with Mild to Moderate Depression and High Cardiovascular Disease Risks: A Randomised Attention-Controlled Trial

<div><p>Background and Aim</p><p>Mild to moderate depression is common in those with cardiovascular disease and undertreated. We aimed to evaluate the effectiveness of internet-delivered Cognitive Behaviour Therapy (iCBT) on depressive symptom severity and adherence to medical advice and lifestyle interventions in adults with mild to moderate depression and high cardiovascular disease (CVD) risks.</p> <p>Methods</p><p>Randomised double-blind, 12 week attention-controlled trial comparing an iCBT programme (<i>E-couch</i>) with an internet-delivered attention control health information package (<i>HealthWatch</i>, n = 282). The primary outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: <a href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335062" target="_blank">ACTRN12610000085077</a>).</p> <p>Results</p><p>487/562 (88%) participants completed the endpoint assessment. 383/562 (70%) were currently treated for cardiovascular disease and 314/562 (56%) had at least one other comorbid condition. In ITT analysis of 562 participants iCBT produced a greater decline in the mean PHQ-9 score compared to the attention control of 1.06 (95% CI: 0.23–1.89) points, with differences between the two arms increasing over the intervention period (time by treatment effect interaction p = .012). There were also larger improvements in adherence (2.16 points; 95% CI: 0.33–3.99), reductions in anxiety (0.96 points; 95% CI: 0.19–1.73), and a greater proportion engaging in beneficial physical activity (Odds Ratio 1.91, 95%CI: 1.01–3.61) in the iCBT participants but no effect upon disability, or walking time/day. There were no withdrawals due to study related adverse events.</p> <p>Conclusions</p><p>In people with mild to moderate depression and high levels of CVD risk factors, a freely accessible iCBT programme (<a href="http://www.ecouch.anu.edu.au" target="_blank">http://www.ecouch.anu.edu.au</a>) produced a small, but robust, improvement in depressive symptoms, adherence and some health behaviours.</p> <p>Trial Registration</p><p>Australian and New Zealand Clinical Trials Registry <a href="http://www.anzctr.org.au;ACTRN12610000085077.aspx" target="_blank">ACTRN12610000085077</a></p> </div

Baseline demographic and health characteristics of 562 participants randomised to either iCBT (<i>E-couch</i>) or attention control health information (<i>HealthWatch</i>).

*<p>Scaled 0–100.</p>**<p>Missing data for one participant who did not complete baseline assessment.</p>***<p>Prior Diagnosis of Cardiovascular Disease includes doctor diagnosis of any one of Heart Disease, Stroke or Hypertension.</p>$<p>At least 150 mins of activity over at least 5 sessions each week.</p>#<p>Other comorbid conditions include: cancer (skin, prostate, breast or other cancer), blood clot (thrombosis), asthma, Parkinson’s disease, osteoarthritis, and/or thyroid problems.</p>##<p>Treatment for any Cardiovascular Disease includes: any one of heart attack/angina, other heart disease, hypertension or high blood cholesterol.</p

Observed activity and disability (cutback days) measures for iCBT (<i>E-couch</i>) and active control (<i>HealthWatch</i>) at baseline and post intervention.

*<p>- “sedentary” defined as reporting no physical activity per week.</p><p>- “sufficient activity” defined as at least 150 mins of activity over at least 5 sessions each week.</p>**<p>- cutback days defined as number of days in last month where respondent reported “cutting back or reducing their usual activities or work as a result of a health condition”.</p

Baseline to post-intervention change under iCBT (<i>E-couch</i>) and control (<i>HealthWatch</i>) on depression, adherence, anxiety, disability and activity measures.

<p>All contrasts are scaled so that a positive value indicates improvement.</p><p>Contrast value (95% Confidence Interval).</p