Treatment of Dysthymia and Minor Depression in Primary Care A Randomized Trial in Patients Aged 18 to 59 Years

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Original Research

Treatment of Dysthymia and Minor Depression in Primary Care A Randomized Trial in Patients Aged 18 to 59 Years

J Fam Pract. 2001 May;50(5):405-412

References

1. Barrett J, Barrett J, Oxman T, Gerber P. The prevalence of psychiatric disorders in a primary care practice. Arch Gen Psychiatry 1988;45:1100-06.

2. Katon W, Schulberg H. Epidemiology of depression in primary care. Gen Hosp Psychiatry 1992;14:237-47.

3. Browne G, Steiner M, Roberts J, et al. Prevalence of dysthymic disorder in primary care. J Affect Dis 1999;54:303-08.

4. Broadhead W, Blazer D, George L, Tse C. Depression, disability days, and days lost from work in a prospective epidemiologic survey. JAMA 1990;264:2524-28.

5. Williams J, Kerber C, Mulrow C, Medina A, Aguilar C. Depressive disorders in primary care: prevalence, functional disability, and identification. J Gen Intern Med 1995;10:7-12.

6. Jaffe A, Froom J, Galambos N. Minor depression and functional impairment. Arch Fam Med 1994;3:1081-86.

7. Howland RH. General health, health care utilization, and medical comorbidity in dysthymia. Int J Psychiatry Med 1993;23:211-38.

8. Katon W, VonKorff M, Lin E, et al. Distressed high utilizers of medical care. Gen Hosp Psychiatry 1990;12:355-62.

9. Wells K, Burnam M, Rogers W, Hays R, Camp P. The course of depression in adult outpatients: results from the Medical Outcomes Study. Arch Gen Psychiatry 1992;49:788-94.

10. Barrett J. Practice-based mental health research in primary care: directions for the 90’s. In: Hibbard H, Nutting P, Grady M, eds. Primary care research: theory and methods. Washington, DC: Department of Health and Human Services; 1991.

11. Markowitz JC. Psychotherapy of dysthymia. Am J Psychiatry 1994;151:1114-21.

12. Mulrow C, Williams J, Trivedi M, et al. Treatment of depression: newer pharmacotherapies. Evidence report/technology assessment No. 7. Rockville, Md: Agency for Health Care Policy Research; 1999.

13. Mulrow CD, Williams JW, Jr, Trivedi M, et al. Treatment of depression—newer pharmacotherapies. Psychopharmacol Bull 1998;34:409-795.

14. Williams J, Rost K, Dietrich A, Ciotti M, Zyzansky S, Cornell J. Primary care physicians’ approach to depressive disorders: effects of physician specialty and practice structure. Arch Fam Med 1999;8:58-67.

15. Linden M, Lecrubier Y, Bellantuono C, Benkert,, Kisely S, Simon G. The prescribing of psychotropic drugs by primary care physicians: an international collaborative study. J Clin Psychopharmacol 1999;19:132-40.

16. Gath D, Catalan J. The treatment of emotional disorders in general practice: psychological methods versus medication. J Psychosom Res 1986;30:381-86.

17. Mynors-Wallis L, Gath D, Lloyd-Thomas A, Tomlinson D. Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care. BMJ 1995;310:441-45.

18. Mynors-Wallis L. Problem-solving treatment: evidence for effectiveness and feasibility in primary care. Int J Psychiatry Med 1996;26:249-62.

19. Barrett J, Williams J, Oxman T, et al. The Treatment Effectiveness Project: a comparison of the effectiveness of paroxetine, problem-solving therapy, and placebo in the treatment of minor depression and dysthymia in primary care patients: background and research plan. Gen Hosp Psychiatry 1999;21:260-73.

20. Williams J, Barrett J, Oxman T, et al. Treatment of dysthymia and minor depression in primary care: a randomized trial comparing placebo, paroxetine and problem-solving therapy. JAMA 2000;284:1570-72.

21. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 3rd ed, revised. Washington, DC: American Psychiatric Association; 1987.

22. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62.

23. Spitzer R, Williams J, Kroenke K, et al. Utility of a new procedure for diagnosing mental disorders in primary care: the PRIME-MD 1000 Study. JAMA 1994;14:1749-56.

24. Hegel M, Barrett J, Oxman T. Training therapists in problem-solving treatment of depressive disorders in primary care: lessons learned from the Treatment Effectiveness Project. Fam Syst Health 2000;18:423-35.

25. Parkerson G, Broadhead W, Tse C. The Duke Severity of Illness Checklist (DUSOI) for measurement of severity and comorbidity. J Clin Epidemiol 1993;46:379-93.

26. Lipman R, Covi L, Shapiro A. The Hopkins Symptom Check List (HSCL): factors derived from the HSCL-90. J Affect Dis 1979;1:9-24.

27. Katon W, Von Korff M, Lin E, et al. Collaborative management to achieve treatment guidelines: impact on depression in primary care. JAMA 1995;273:1026-31.

28. Ware J, Snow K, Kosinski M, Gandek B. SF-36 Health survey: manual and interpretation guide. In: Institute TH, ed. Boston, Mass: New England Medical Center; 1993.

29. Ware J, Kosinski M, Bayliss M. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care 1995;33:AS264-79.

30. Lange N, Carlin B, Gelfand A. Hierarchical bayes models for the progression of HIV infection using longitudinal CD4 T-cell numbers. JASA 1992;87:615-26.

31. SAS Institute, Inc. SAS/STAT software: changes and enhancements. Cary, NC: SAS Institute, Inc; 1996.

32. Kirk R. Experimental design: procedures for the behavioral sciences. New York, NY: Brecks/Cole; 1995.

33. Frank E, Prien R, Jarrett R, et al. Conceptualization and rationale for consensus definitions of terms in major depressive disorder: remission, recovery, relapse, and recurrence. Arch Gen Psychiatry 1991;48:851-55.

34. Katon W, Russo J, Frank E, et al. Predictors of non-response to treatment in primary care patients with dysthymia. In press. [Author: Has this been published yet?]

35. Frank E, Rucci P, Katon W, et al. Correlates of response to treatment in primary care patients with minor depression. In press. [Author: Has this been published yet?]

36. Wells KB, Sherbourne C, Schoenbaum M, et al. Impact of disseminating quality improvement programs for depression in managed primary care: a randomized controlled trial. JAMA 2000;283:212-20.

37. Rost K, Nutting P, Smith J, Coyne JC, Cooper-Patrick L, Rubenstein L. The role of competing demands in the treatment provided primary care patients with major depression. Arch Fam Med 2000;9:150-54.

Strengths and Limitations

Our study has several strengths. It is focused on those depressive disorders, dysthymia and minor depression, that are common in primary care and are treated most often in that setting. The inclusion criteria were broad, permitting results to be generalizable to the majority of patients with these disorders presenting in primary care. The treatments were provided in the primary care setting, emphasizing their potential practicality for primary care practice. For the medication intervention, this placebo-controlled trial contributes to the scientific knowledge base concerning treatments in primary care. There are relatively few such controlled trials for dysthymia and even fewer for minor depression.

This is the first treatment trial outside of the United Kingdom in which the behavioral treatment PST-PC was used. As in the United Kingdom, PST-PC had a high patient acceptance rate; 80% of the patients assigned to it completed all 6 visits and 87% of those coming for one visit completed 4. On some outcome measures, it had effectiveness similar to paroxetine and greater than placebo plus clinical management, although it showed greater variability by site than paroxetine. In this trial, PST-PC therapists varied on the level of previous experience with behavioral therapy treatment, overall experience, and number of patients treated with PST-PC, all variables that may have related to their skill in delivering the treatment. Analyses are in progress to examine the effects of these and other variables on PST-PC outcome. The results reported here indicate PST-PC has promise but cannot be considered an established treatment alternative to antidepressants in depressed primary care patients, as it is in the United Kingdom.

Our study also has shortcomings. The placebo-controlled condition involved contact with a clinician for 6 visits over the 11-week trial, considerably more than usually takes place in primary care. Whether this nonspecific clinician contact related to the relatively high improvement (remission rates) for placebo, particularly for those with minor depression, cannot be assessed in our study. In retrospect, including a true “treatment as usual” group making 2 to 3 in-person visits over 11 weeks would have clarified these results. Also, the clinical significance of the amount of symptom reduction observed in the scale analyses (SF-36-MHC, HSCL-D-20) is difficult to establish. The amounts of those reductions were modest, even when statistically significant. For clinical significance, one must rely primarily on the remission analyses that were based on those patients receiving adequate exposure to the treatments, not an intention-to-treat group.

Further Research

Variation in outcome by site was a problem in this data, as it was in the group of patients 60 years and older. Further analyses have taken place, to be reported in separate publications,^34,35 in an attempt to examine the effect of other variables, such as demographics, level of medical comorbidity, or personality variables such as neuroticism. The findings we reported on patients aged 18 to 59 years and those reported elsewhere for the patients 60 years and older are examining only the effects of diagnosis, treatment received, and site. The effect, if any, of various moderator variables was not examined but will be in these later reports.

Conclusions

Evidence-based guidelines are available to direct primary care physicians’ treatment for major depression, and when implemented well, they improve patient outcomes.^27,36,37 For the treatment of minor depression and dysthymia, evidence-based guidelines are unavailable, because the evidence base is insufficient to develop recommendations.

Our results showed that paroxetine andto a lesser degree PST-PC improved remission of dysthymia more than the use of placebo plus nonspecific clinical management. Results varied for the other outcomes measured. For minor depression, the 3 interventions (paroxetine, PST-PC, and placebo) were equally effective, so general clinical management is an appropriate treatment option.

Acknowledgments

Our project was supported by the John D. and Catherine T. MacArthur Foundation, Chicago, Illinois, and by the John A. Hartford Foundation, New York, New York. In the early planning stages of the project design advice was provided by George Alexopoulis, MD; Daniel Blazer, MD; Christopher Callahan, MD; Charles Reynolds, MD; Carl Salzman, PhD; and Herbert Schulberg, PhD. Helena Kraemer, PhD, from Stanford University provided statistical and data analytic advice; Laurence Mynors-Wallis, MD, currently at the University of Southampton provided the initial training in PST-PC.

Related resources

Agency for Health Care Policy and Research—Consumer Guideline #5: Depression is a Treatable llness http://text.nlm.nih.gov/ftrs/pick?collect=ahcpr&dbName=depp&cd=1&t=96928766
American Medical Association—Consumer Health Information: Insight on Depression http://www.ama-assn.org/insight/spec_con/depressn/depressn.htm
American Psychiatric Association—APA On-line Public Information http://www.psych.org/public_info
American Psychological Association—APA Resources for the Public: What You Need to Know About Depression http://www.apa.org/psychnet/depression.html
MacArthur Initiative on Depression in Primary care www.depression-primarycare.org