STUDY DESIGN: This was an 11-week randomized placebo-controlled trial conducted in primary care practices in 2 communities (Lebanon, NH, and Seattle, Wash). Paroxetine (n=80) or placebo (n=81) therapy was started at 10 mg per day and increased to a maximum 40 mg per day, or PST-PC was provided (n=80). There were 6 scheduled visits for all treatment conditions.
POPULATION: We included a total of 241 primary care patients with minor depression (n=114) or dysthymia (n=127). Of these, 191 patients (79.3%) completed all treatment visits.
OUTCOMES: We measured depressive symptoms using the 20-item Hopkins Depression Scale (HSCL-D-20). Remission was scored on the Hamilton Depression Rating Scale (HDRS) as less than or equal to 6 at 11 weeks. We measured functional status with the physical health component (PHC) and mental health component (MHC) of the 36-item Medical Outcomes Study Short Form.
RESULTS: All treatment conditions showed a significant decline in depressive symptoms over the 11-week period. There were no significant differences between the interventions or by diagnosis. For dysthymia the remission rate for paroxetine (80%) and PST-PC (57%) was significantly higher than for placebo (44%, P=.008). The remission rate was high for minor depression (64%) and similar for each treatment group. For the MHC there were significant outcome differences related to baseline level for paroxetine compared with placebo. For the PHC there were no significant differences between the treatment groups.
CONCLUSIONS: For dysthymia, paroxetine and PST-PC improved remission compared with placebo plus nonspecific clinical management. Results varied for the other outcomes measured. For minor depression, the 3 interventions were equally effective; general clinical management (watchful waiting) is an appropriate treatment option.
Dysthymia and minor depression are common depressive disorders in patients in primary care settings.1-3 Together with major depression, these 3 disorders account for the vast majority of depressive illness present in primary care. Although the level of depressive symptomatology for these patients is less than that for major depression, these disorders are accompanied by significant morbidity,4-6 and their impact on the health delivery system is considerable.4,7-9 However, there are relatively few controlled trials in primary care examining the effectiveness of recommended treatments for these disorders.10-13 Studies in this area have typically involved small groups of patients, and generalizability was limited because of such factors as stringent entrance criteria that would exclude many primary care patients with these disorders. The need for treatment outcome data for the majority of these patients seen in primary care was a principal reason for our study.
Antidepressant medications, particularly the selective serotonin reuptake inhibitors, are commonly used for treatment of depression in primary care.14,15 Support and watchful waiting make up another common method of treatment.14 Psychologic treatments that customarily require referral to mental health providers have also been used, although stigma, fear of loss of confidentiality, increased cost, limited access in some localities, and local cultural preferences have limited their use as a treatment option. In part to address these issues a behaviorally based psychologic treatment—Problem-Solving Treatment for Primary Care (PST-PC)—was developed in the United Kingdom.16 This treatment was relatively brief and could be applied in the primary care setting. In studies involving patients with major depression in the United Kingdom, the treatment had high patient acceptance and an effectiveness comparable with antidepressants,17,18 making it an attractive alternative when patients did not want pharmacotherapy or if such treatment was contraindicated for medical reasons. For dysthymia and minor depression there are no studies specifically examining the effectiveness of PST-PC, but this treatment has potential utility for those conditions.
In 1995 the MacArthur Foundation and the Hartford Foundation provided funding for a comparative treatment trial. The project’s development and methodology have been outlined in an earlier report.19 Four sites recruited patients 60 years and older; the results of that study have been reported elsewhere.20 Two sites recruited patients aged 18 to 59 years. We present outcome data for this younger group.
Methods
Patients aged 18 to 59 years were recruited from primary care settings at 2 participating sites (Lebanon, New Hampshire, and Seattle, Washington). To be eligible, patients had to meet Diagnostic and Statistical Manual of Mental Disorders, third edition, revised (DSM-III-R) criteria for dysthymia,21 or specified criteria for minor depression and score 10 or higher on the 17-item Hamilton Depression Rating Scale (HDRS).22 To receive a diagnosis of minor depression, 3 of the 9 DSM-III-R symptoms for major depression (1 of these had to be depressed mood or anhedonia) had to be present for at least 4 weeks. Depression diagnoses were made by a research psychiatrist using the Primary Care Evaluation of Mental Disorders (PRIME-MD), a diagnostic instrument designed for use in primary care.23