Psychosomatics 45:319-324, August 2004
© 2004 The Academy of Psychosomatic Medicine
An Open-Label Trial of Interpersonal Psychotherapy in Depressed Patients With Coronary Disease
Diana Koszycki, Ph.D.,
Sylvain Lafontaine, M.D., F.R.C.P.C.,
Nancy Frasure-Smith, Ph.D.,
Robert Swenson, M.D., F.R.C.P.C., and
François Lespérance, M.D., F.R.C.P.C.
Received May 15, 2003; revision received Oct. 21, 2003; accepted Nov. 24, 2003. From the University of Ottawa Heart Institute and the Institute of Mental Health Research, Royal Ottawa Hospital; the Department of Psychiatry, School of Nursing, and the Department of Epidemiology and Biostatistics, McGill University, Montreal; the Department of Psychiatry, University of Montreal; the Centre Hospitalier de l'Université de Montreal Research Center, Montreal; and the Montreal Heart Institute Research Centre, Montreal. Address reprint requests to Dr. Koszycki, Stress and Anxiety Clinical Research Unit, Royal Ottawa Hospital, 1145 Carling Ave., Ottawa, Ont. K1Z 7K4 Canada; dkoszyck{at}rohcg.on.ca (e-mail).
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ABSTRACT
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High rates of depression have been reported in patients with coronary artery disease, and depression has been repeatedly shown to adversely affect cardiac morbidity and mortality. Despite these findings, little work has been devoted to evaluating effective antidepressant treatments for this subpopulation. This open-label trial assessed the efficacy and acceptability of interpersonal psychotherapy in depressed patients with stable coronary artery disease. Seventeen patients with coronary artery disease who met DSM-IV criteria for major depression received 12 weekly sessions of interpersonal psychotherapy. Outcome was assessed with the 17-item Hamilton Depression Rating Scale and the Beck Depression Inventory II. Ten patients received medication during the trial, and seven patients received interpersonal psychotherapy alone. The patients showed a significant reduction in scores on both the Hamilton depression scale and the Beck Depression Inventory II from baseline, with 53% of the patients meeting criteria for remission, as defined by scores of  7 and 14 on the Hamilton depression scale and the Beck Depression Inventory II, respectively. Medicated and unmedicated patients responded similarly to interpersonal psychotherapy. These data provide support for the potential use of interpersonal psychotherapy in depressed patients with coronary artery disease. The therapy was well tolerated and accepted by patients, with a high proportion achieving remission. Future randomized clinical trials are needed to establish its efficacy.
Key Words: depression • other psychotherapy • syndromes secondary to medical disorders
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INTRODUCTION
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High rates of depression have been reported in patients with coronary artery disease. Studies have demonstrated that 15%–20% of patients fulfill symptom criteria for major depression during hospitalization for myocardial infarction,1 unstable angina,2 congestive heart failure,3 and bypass surgery,4 with another 15%–25% experiencing mild forms of depression. Longitudinal assessments have indicated that depression can last for many months after resolution of the cardiac event, resulting in significant psychological suffering, impairment, and disability.5 One of the most serious consequences of depression in patients with coronary artery disease is cardiac mortality over the first year; this risk extends to minor forms of depression as well.1,6,7 Furthermore, the prognostic impact of depression is as large as, and independent of, other major prognostic factors, including ventricular dysfunction and severity of coronary atherosclerosis. The mechanism by which depression increases cardiac morbidity and mortality is not well understood. Nevertheless, the finding that depression in patients with coronary artery disease is not inconsequential highlights the need for early recognition and optimal treatment of depressive symptoms.
Therapeutic options for the treatment of depression in nonmedically ill patients include depression-focused psychotherapies, antidepressant drugs, and their combination. Among the psychotherapies, cognitive behavior therapy and interpersonal psychotherapy are the most effective as both acute and maintenance treatments.8 However, the efficacy of these evidence-based psychotherapies in depressed patients with coronary artery disease is unknown, and their widespread use is limited by the lack of suitably trained therapists. Pharmacotherapy is universally available through primary care physicians and, for many, represents the first choice of treatment. Unfortunately, well-designed placebo-controlled trials of pharmacological treatments for depressed patients with coronary artery disease are conspicuously absent because medically ill patients have typically been excluded from drug trials. As a result, we cannot assure patients that they will experience the same levels of efficacy and tolerability as medically healthy patients who are depressed. Given the high lifetime rate of depression in cardiac patients and its serious impact on morbidity and mortality, appreciable efforts need to be devoted to evaluating the safety, efficacy, and acceptability of different treatment modalities in this population and to developing guidelines to help clinicians choose optimal treatments.
One treatment that may be beneficial for depressed cardiac patients is interpersonal psychotherapy. Interpersonal psychotherapy is a time-limited (12–16 sessions) manualized psychotherapy that was specifically developed for the treatment of unipolar major depression.9 The therapy has been extensively researched and shown to be effective in different depressed populations, including patients with HIV, ambulatory medical patients, and the elderly.10–12 Interpersonal psychotherapy views depression as a medical illness, and the patient is given the "sick role" that requires treatment. The medically oriented approach to interpersonal psychotherapy helps patients see their depressive symptoms as part of an illness rather than aspects of their personality and facilitates combining psychotherapy and pharmacotherapy, if necessary.9 Theoretically, interpersonal psychotherapy makes no assumptions about the etiology of depression but emphasizes the current social and interpersonal context associated with disturbed mood.13 For each patient, therapy focuses on one or, at most, two interpersonal problem areas that are identified as precursors to the current depressive episode. These problem areas were derived from extensive research on the role of environmental influences on mood and are characterized as unresolved grief following the death of a loved one, role transitions (difficulty adjusting to changed life circumstances), interpersonal role disputes (conflicts with a significant other), and interpersonal deficits (impoverished social networks). The primary goal of interpersonal psychotherapy is to treat the depressive episode by helping patients link their depressive episode to current interpersonal stresses and facilitating resolution of these stresses.9,13
Interpersonal psychotherapy addresses a number of psychosocial stressors common to cardiac patients, including the social isolation that has been linked to increased mortality and morbidity in several epidemiological studies of patients with coronary artery disease;14–16 struggles with significant others that lead to anger, hostility, and distress; grief; and loss. Because interpersonal psychotherapy seems to be a particularly relevant therapy for depressed patients with coronary artery disease, we conducted an open-label pilot study to evaluate its efficacy and acceptability in patients with coronary artery disease and major depression.
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METHOD
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Patients were recruited from two large university-based cardiology institutes. Seventeen outpatients with stable coronary artery disease who met DSM-IV criteria for major depressive disorder provided written informed consent to participate in this open-label trial. Diagnosis of major depressive disorder was made by the treating physician using DSM-IV criteria. For 12 patients, a diagnosis of major depressive disorder was independently confirmed by structured interview (the Structured Clinical Interview for DSM-IV) with a psychologist. Patients were excluded from the study if they had the following characteristics:
- Met DSM-IV criteria for bipolar I disorder or major depressive disorder with psychotic features
- Were at serious risk of suicide
- Met DSM-IV criteria for substance abuse or dependence in the past 6 months
- Had clinically significant cognitive problems
- Were currently participating in another trial
- Were unable to speak English or French
- Were unable to attend weekly interpersonal psychotherapy sessions
Interpersonal psychotherapy was delivered over 12 weekly sessions by two psychiatrists who were trained in interpersonal psychotherapy and had extensive experience treating patients with coronary artery disease. Therapy was discontinued if there was a significant worsening of depressive symptoms, if the patient deviated from the study protocol, if the therapist considered it advisable or in the patient's best interest, or if the patient withdrew consent. Therapy followed the treatment manual of Weissman and colleagues,17 with slight modifications for patients with coronary artery disease. This included a shorter duration of sessions (12 weekly sessions of 45–50 minutes instead of 16 weekly 1-hour sessions), an allowance to conduct some therapy sessions by telephone if the patient was too ill to come to the therapist's office or required hospitalization, regular monitoring of psychiatric and cardiac symptoms, education about cardiac disease and the negative prognostic impact of untreated depression on cardiac status, and informing patients that they had two medical illnesses: depression and cardiac disease.
The early phase of therapy (sessions 1–3) included a diagnostic assessment; an assessment of the patient's social relationships and interpersonal functioning; psychoeducation about depression, cardiac disease, and giving the patient the "sick role"; establishing the interpersonal problem area that would be the focus of the remainder of therapy; evaluating the need for antidepressant medication; and developing a treatment plan. The middle phase (sessions 4–9) focused on solving the interpersonal problem by using specific techniques and strategies outlined in the manual. The termination phase (sessions 10–12) involved consolidating treatment gains, fostering a sense of independence and competence, and providing skills for relapse prevention.
Treatment efficacy was evaluated with the 17-item Hamilton Depression Rating Scale that was completed by the therapist before the beginning of therapy and after the final session. The patients also completed the Beck Depression Inventory II. Data were analyzed with an intent-to-treat approach with the last observation carried forward. Paired t tests were used to compare baseline depression scores with the final observation. Repeated measures analysis of variance (ANOVA) was also carried out to examine differences in efficacy in relation to prescription medication.
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RESULTS
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Demographic and pretreatment clinical characteristics of the study group are summarized in Table 1. The interpersonal problem areas that were the focus of treatment were role transitions (N=10), role disputes (N=8), pathological grief (N=2), and interpersonal deficits (N=1). Thirteen patients had one problem area, and four patients had a primary and secondary problem area. Twelve patients completed the full 12 weeks of treatment. The mean number of interpersonal psychotherapy sessions completed was 10.4 (SD=2.5). All sessions were conducted in the therapist's office. Of the patients who stopped treatment early, all but one completed at least 7 weeks of interpersonal psychotherapy. Reasons for terminating early were lack of efficacy (N=1), remission of symptoms (N=2) and patient choice (N=2). The two remitted patients who terminated treatment early completed 9 and 10 weeks of therapy, respectively, and the decision to conclude the sessions early was based on mutual agreement between the patient and therapist.
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TABLE 1. Demographic and Pretreatment Clinical Characteristics of 17 Depressed Patients With Coronary Artery Disease
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Mean baseline and endpoint Hamilton depression scale and Beck Depression Inventory II scores are shown in Table 2. Paired t tests revealed a significant reduction from baseline in Hamilton depression scale (t=11.42, df=16, p<0.001) and Beck Depression Inventory II (t=3.61, df=16, p<0.02) scores. Fifty-three percent (nine of 17) of the patients achieved a 50% reduction in both their Hamilton depression scale and Beck Depression Inventory II scores. Furthermore, nine patients (53%) met criteria for remission as defined as a score 7 on the Hamilton depression scale and a score 14 on the Beck Depression Inventory II.
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TABLE 2. Mood Ratings at Baseline and Endpoint of 17 Depressed Patients With Coronary Artery Disease Receiving Interpersonal Psychotherapy
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Ten patients received antidepressant medication at some point during the trial. Concomitant medication included citalopram (N=6; 20 mg/day), venlafaxine (N=3; 37.5 mg/day, 75 mg/day, and 225 mg/day), and buproprion hydrochloride (N=1; 100 mg/day). Three patients were taking medication before participating in the study and did not change their dose after initiation of interpersonal psychotherapy. Three patients were given a prescription for medication during the initial phase of therapy (i.e., weeks 1–3), three during the middle phase (i.e., weeks 4–9), and one during the termination phase (i.e., weeks 10–12). The primary reason for prescribing medication after initiation of interpersonal psychotherapy was persistent neurovegetative symptoms. Repeated measures ANOVA revealed that medicated patients had somewhat higher Beck Depression Inventory II scores than unmedicated patients at both baseline and endpoint assessments (F=3.87, df=1, 15, p<0.07). However, both groups exhibited a similar decline in Beck Depression Inventory II scores from baseline. Mean baseline and endpoint Beck Depression Inventory II scores were 30.0 (SD=9.3) and 19.3 (SD=12.2) for the medicated patients and 24.4 (SD=4.3) and 11.6 (SD=6.3) for the unmedicated patients. Medication status was unrelated to Hamilton depression scale scores. Mean baseline and endpoint Hamilton depression scale scores were 25.1 (SD=3.7) and 6.2 (SD=5.5) for the medicated patients and 23.4 (SD=5.0) and 4.6 (SD=3.9) for the unmedicated patients.
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DISCUSSION
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The data from this pilot open-label trial suggests that interpersonal psychotherapy may be beneficial, either alone or as an adjunct to medication, for depressed patients with coronary artery disease. Significant reductions in scores on both the Hamilton depression scale and Beck Depression Inventory II were achieved, with over half of the subjects meeting our stringent criteria for remission. Only one patient dropped out of the study because of poor treatment response. The finding that unmedicated and medicated patients responded similarly to interpersonal psychotherapy suggests that interpersonal psychotherapy alone could be an alternative treatment for patients who prefer a nonpharmacological approach or who may be particularly sensitive to the adverse effects of antidepressant drugs. Our study also reveals that interpersonal psychotherapy requires minimal adaptation for patients with coronary artery disease and that it is well accepted and tolerated by patients. Twelve weeks of interpersonal psychotherapy appears to be sufficient to alleviate depressive symptoms in a substantial number of patients experiencing moderate to severe depression.
Our results compare well with other research on the efficacy of interpersonal psychotherapy in medically ill patients. For example, in a study of depressed HIV patients who received 16 weeks of interpersonal psychotherapy, scores on the Hamilton depression scale and Beck Depression Inventory II at endpoint were 8.3 (SD=7.5) and 14.0 (SD=12.1), respectively.10 Remission, as defined by a Hamilton depression scale score of <6, was achieved by 46% of the patients. Our remission rate of 53% was based on more stringent criteria for classifying patients as remitters (Hamilton depression scale score of 7 and Beck Depression Inventory II score of 14). When we used the same criterion as the HIV study, our remission rate increased to 71%. Results from the present study also suggest that interpersonal psychotherapy, when used as monotherapy or in conjunction with medication, may produce larger treatment effects than medication alone. In an open-label trial of 16 weeks of sertraline in depressed patients after myocardial infarction, the mean difference between baseline and endpoint was 9.4 for the 17-item Hamilton depression scale and 6.9 for the Beck Depression Inventory II.18 In the present study, a twofold greater difference between baseline and endpoint in these measures was observed for both medicated (18.9 points for the Hamilton depression scale and 11.6 points for the Beck Depression Inventory II) and unmedicated (18.8 points for the Hamilton depression scale and 12.8 points for the Beck Depression Inventory II) patients. In addition, rates of treatment response, based on a 50% decline in Hamilton depression scale scores, were 62.5% in the sertraline study versus 94% in the present study. Our Hamilton depression scale change score was also larger than that reported in the Sertraline Antidepressant Heart Attack Randomized Trial, which evaluated the efficacy of sertraline in depressed patients with acute myocardial infarction or unstable angina.19 In this study, the mean difference in endpoint scores on the 17-item Hamilton depression scale for sertraline-treated patients was 8.4 for the total group and 12.3 for the subgroup of patients with more severe depression. Although comparative studies are needed to verify whether interpersonal psychotherapy alone or in combination with medication is indeed more efficacious than medication alone, our results suggest that addressing and resolving current psychosocial problems may enhance treatment outcome in depressed patients with coronary artery disease.
Of the four interpersonal psychotherapy problems areas, role disputes and role transitions were the most common foci of therapy. Role disputes are the focus of therapy when the patient and a significant other have nonreciprocal expectations about the relationship.9,17 For patients in the present study, disputes occurred primarily with spouses and revolved around issues of role function, decreased levels of involvement, and lack of emotional support. Many patients were struggling with overwhelming fears about future cardiac events, and their preoccupation with their health placed a strain on their marriage, with their spouse becoming increasingly angry and resentful at the patient's illness and withdrawing needed support. The loss of emotional support and unsuccessful attempts at renegotiating the relationship left patients feeling hopeless and depressed. We also observed that depression itself led to problematic interactions with others. Similar to nonmedically ill depressed patients,20 our depressed patients with coronary artery disease were less effective in extracting support from others, including health care providers, and often elicited eventual rejection because of irritability and a negative affect. The outcome of this was a reduction in rewarding social interactions and increased social isolation and despair. In interpersonal psychotherapy, the treatment of role disputes involves helping patients identify the dispute, explore options for changing the relationship, modify expectations of the relationship and maladaptive communication patterns, and extend and strengthen interpersonal supports.17
Role transitions are the focus of therapy when a person has difficulty adapting to changes in life circumstances.17 Like other serious medical conditions, coronary artery disease can be conceptualized as a role transition characterized by a loss of health, uncertainty about the future, and the life changes the disease produces. In our patients, coronary artery disease resulted in alterations in everyday roles as well as a loss of independence, productivity, valued activities, and social supports and attachments. The patients also struggled with the demands of complying with disease-controlling or health-promoting behaviors, such as smoking cessation, diet, and regular exercise. These losses and demands were perceived as overwhelming and difficult by patients. We have also observed that the behavioral manifestations of depression can undercut adaptive coping to life changes that arise because of coronary artery disease. For example, loss of interest and decreased energy compromised some patients' ability to follow through on prescribed behaviors that elicit and maintain good cardiac health. Similarly, social withdrawal interfered with the patients' ability to seek out and effectively use social support networks that could potentially benefit them by enhancing adherence to health-promoting behaviors and providing role models for effective coping. In interpersonal psychotherapy, the treatment of role transitions involves helping patients mourn and accept the loss of the old role, adapt more effectively to the life changes associated with coronary artery disease, find new life goals, restore a sense of self and integrity, create new social ties, and facilitate the acquisition of new skills necessary for the new role.17
In conclusion, this open-label pilot trial suggests that interpersonal psychotherapy may be a promising antidepressant psychotherapy for depressed patients with coronary artery disease. Currently, we are conducting a large-scale randomized trial of the efficacy of interpersonal psychotherapy, alone or in combination with citalopram, in depressed cardiac patients. The results of this study will provide a more definitive evaluation of the usefulness of interpersonal psychotherapy for the treatment of depression in coronary artery disease.
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ACKNOWLEDGMENTS
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Supported in part by a grant from the Canadian Institutes of Health Research through the Tri-Council Workshop/Networking Program.
The authors thank Ginette Gravel, M.Sc., for technical assistance and Marie-Pierre Leduc, B.Sc., Isabelle Menard, M.Sc., and Michel Loyer, M.Sc, for their help.
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ABSTRACT
INTRODUCTION
