Can cognitive behavior therapy reduce heart risks?

A large-scale clinical trial of cognitive behavioral therapy is teaching psychologists how to work with a model of treatment outcome studies.

By Beth Azar
Monitor staff

The largest-ever controlled clinical trial of a psychosocial intervention for depression under way at medical centers around the country?will not only reveal whether treating depression in heart patients can lengthen life, but may serve as a model for future studies of its type.

The Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients Study, initiated and funded by the National Heart, Lung and Blood Institute (NHLBI), will attempt to determine whether cognitive behavioral therapy reduces the risk of death or subsequent heart attack in a group of 3,000 heart attack patients who suffer from depression or have low social support.

ENRICHD is based on a substantial body of epidemiological and psychological research on heart disease patients showing that people who are depressed or socially isolated after a heart attack have a higher than average risk of another heart attack or death. Several small-scale studies indicate that psychosocial treatments?including group counseling and behavioral interventions?improve cardiac patients? outcomes. But ENRICHD is the first large-scale study to test whether cognitive behavior therapy, designed specifically to treat depression and social isolation, can improve a patient?s health and long-term survival, says psychologist Susan Czajkowski, PhD, NHLBI project officer for ENRICHD.

'I think that the science leadership, including our Director Dr. [Claude] Lenfant, is visionary for supporting this trial,' says Czajkowski. 'It?s really cutting-edge and a vanguard of its type. This was a case where there was a need to answer a question and an obvious way to answer it.'

For a psychosocial intervention study, ENRICHD is unique in its size and scope, say researchers familiar with it. Interdisciplinary research teams in eight states are recruiting more than 300 patients each, including an over-representation of women and minorities?two groups traditionally overlooked in medical research. Eligible participants?who have just survived a heart attack and show signs of depression or social isolation?are randomly assigned to receive standard medical treatment, or medical treatment along with highly standardized cognitive behavioral therapy aimed at treating their depression and providing them with social support.

Although the study?s interdisciplinary nature makes its coordination a challenge, the study is an important step for the behavioral research community, says Czajkowski. Until this study?which includes six psychologists among eight principal investigators?the community had little experience with this model of large, multicenter, randomized clinical trials.

'In biomedical research, these big trials are the vehicles through which treatments are tested and ultimately make it out to the public,' she says. 'If behavioral medicine researchers want a place at the table in terms of affecting the public health, we?ll need to establish the efficacy of our treatments the same way?by participating in these large multicenter trials.'

The ?Tower of Babel?

Although the researchers involved with ENRICHD are excited to be a part of it, the study has been difficult logistically.

'None of us have experience with this [large a trial]?especially the psychologists,' says Washington University psychologist Robert Carney, PhD, one of ENRICHD?s principal investigators.

The research teams have had to 'hammer out a single protocol and that has been sometimes contentious. I often call our meetings the ?Tower of Babel? because everyone is using different language and fighting for different concerns,' he says. 'The cardiologists are worried about the cardiology and the psychologists are worried about the psychology.'

That?s been an issue particularly with the design of the follow-up protocols. Since the cardiologists are mostly interested in long-term outcomes, such as death, they don?t need frequent follow-ups. But for psychologists, the most interesting behavioral changes?including alleviation of depression?are likely to occur early on.

'Clearly, we have different cultures and different ways of looking at the world,' says cardiologist Allan Jaffe, MD, co-chair of ENRICHD. 'We have to do this in a way that has credibility in both the cardiology and the behavioral medicine camps.'

In the end, the researchers have compromised. They are measuring depression, social isolation and myriad indicators of cardiovascular health six months after the patients enter the study, by which point all patients have finished their cognitive-behavioral treatment. The patients then return for evaluations once a year for an average of three years. (Study sites are about half way done with patient recruitment and well into follow-up with some of the patients who have finished therapy. A coordinating center receives all the data and will conduct all analyses.)

Although some investigators have been frustrated by the process of negotiating a common protocol, NHLBI believes that this is the best way to design a clinical trial of this magnitude, and enroll a large number of patients in a relatively short period of time, says Czajkowski. 'There?s pushing and pulling, discussion and compromise. But in the end, I do believe the product is the best of all [the original] ideas.'

Gaining trust

One of the biggest challenges for the principal investigators is gaining the support and trust of hospital staff, says psychologist and ENRICHD investigator James Blumenthal, PhD, of Duke University. To find enough patients who have had a heart attack, are depressed and socially isolated, and are willing and physically able to participate in the study, researchers must recruit from several different medical centers, sometimes as far away as several hundred miles.

Often, physicians 'are sympathetic but [behavioral interventions] are so far removed from their world, they may not give it a lot of thought,' says Blumenthal. 'They?re in the business of treating patients and taking care of them as efficiently and cost effectively as possible. There isn?t by and large a big selling point for us to get physicians interested in the trial.'

'We?re asking them to superimpose [on their regular treatment] a speculative treatment that may or may not work and that has a fair degree of patient commitment,' adds Jaffe from the perspective of the cardiologist. 'We want them to sign on and facilitate a treatment they don?t understand very well?at a time when everyone is pushed for time. Of course there?s resistance from cardiologists. There?s no question there?s some cynicism.'

The researchers also have to approach patients carefully, says University of Miami psychologist Neil Schneiderman, PhD, another ENRICHD principal investigator. 'You don?t want to overburden them initially,' he says. 'And if you coerce them into the trial, when you try to begin treatment they may say they don?t want to do it.'

ENRICHD is a learning experience for all involved, says Schneiderman. The psychologists are learning how to conduct a large clinical trial that requires patient retention rates as high as 95 percent. (It?s common for behavioral treatment clinical trials to have dropout rates as high as 30 percent.) And physicians and cardiologists are learning to trust and support behavioral science.