Baltimore, MD - The use of home-based exercise and cognitive behavioral therapy (CBT) together has led to an improvement in symptoms in a pilot study in depressed patients with heart failure. This is the first-ever research to look at a combination of such treatments, lead investigator Dr Rebecca Gary (Emory University, Atlanta, GA) told heartwire.

Gary presented the results yesterday during a poster session at the American Heart Association 2008 Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Conference.

But she cautioned that the study was small and therefore not powered to show significant differences in outcomes and that the home-based interventions were expensive and labor-intensive. "In terms of the feasibility of doing this on a very large scale—it would be difficult," she commented. However, there are other options, she said, such as using telemonitoring to help deliver some of these programs, and she is currently exploring the possibility of using this method in a future study.

Gary and colleagues randomized 74 heart-failure patients with depression into four groups: one group received a 12-week home-based program of exercise and psychological counseling (n=18); a second got psychological counseling alone (n=19); a third received exercise alone (n=20); and the fourth, usual care (n=17). The patients had an average age of 66 years, had been outpatients for at least three months with NYHA class 2 or class 3 HF, and had to be on optimal medical therapy. All had also been diagnosed with clinical depression.

The latter is one of the reasons that this study is unique, she said, noting that it differs from other studies of exercise in HF because all the patients were clinically depressed. Depression is common in heart failure, with major depression affecting about 30% of outpatients, she noted.

The exercise component was a 12-week progressive program with low-to-moderate-intensity exercise, involving walking outdoors. Patients were encouraged to walk for at least 30 minutes, three times a week, and they received heart-rate monitors and were taught how to self-monitor their exertion level and when to stop exercising.

CBT sessions were conducted one on one in the home once a week for 12 weeks by psychiatric nurses and PhD students trained in counseling techniques. "We had to address their depression, their negative thought patterns," Gary explained.

The fact that the programs were home-based really helped, she said. "The patients really enjoyed not having to get out and drive to site-based programs, so that was a major plus for them." Many of the patients were geriatric, a lot did not drive or have transportation, and many who did were put off leaving the home due to traffic problems, she pointed out. She stressed, however, that those who did want to get out and/or contribute to the community were encouraged to do so via volunteer and activities sign-up sheets, and transportation was provided for them.

Patients were assessed on depression rating scales, by physical-function tests—including the six-minute walking test—and the Minnesota Living with Heart Failure quality-of-life questionnaire at each of four time points: baseline, after the 12-week intervention program, after three months by telephone follow-up, and at six months.

Those in the combined exercise and CBT group did best of all, Gary noted, even racking up a significant difference in the six-minute walking time compared with the usual-care group (p<0.001), despite the study not really being powered to show significance.

The combined group also lowered depressive symptoms by the most over the usual-care group, compared with the other two intervention groups. Interestingly, although depressive symptoms were also lowered in the counseling-only group, they perceived their quality of life to be worse than the combined group or exercise group.

"Another thing that was interesting," said Gary, "was that the group that just got CBT had a fairly significant drop in physical function, almost parallel to that in the usual-care group, and their quality of life worsened over time."

It thus appears that the combination of therapies is particularly beneficial: "I think that's what really made a difference, addressing both the depressive and the physiological symptoms of HF. The findings were very positive in terms of the combined group," she commented.

Nevertheless, although the patients loved the home-based programs, "they were extremely expensive and extremely labor-intensive. I know because I did part of it myself," Gary noted.

She says she is now looking at other options for future trials, such as using a telemonitoring device that can measure blood pressure, weight, and symptom severity remotely. "We can then ask them questions over the phone about their depression or how much they are exercising and offer counseling and advice—it's a little bit easier than going out to them."