A Randomized Controlled Trial of a Close Monitoring Program
for Minor Depression and Distress
Jennifer T. Ross, MS1,3, Thomas TenHave, PhD4, April C. Eakin, BS1, Suzanne Difilippo, RN, CRCC3,
and David W. Oslin, MD1,2,3,5
1Philadelphia Veterans Affairs Medical Center and the VISN 4 Mental Illness Research, Education, and Clinical Center (MIRECC), Philadelphia,
PA, USA;2Philadelphia VA Center of Excellence in Substance Abuse Treatment and Education (CESATE), Philadelphia, PA, USA;3Section
of Geriatric Psychiatry, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA;4Center for Clinical Epidemiology and
Biostatistics, School of Medicine, University of Pennsylvania, Philadelphia, PA, USA;5Center for the Study of Addictions, Department of
Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.
BACKGROUND: Minor depression is almost twice as
common in primary care (PC) as major depression.
Despite the high prevalence, few evidence-based algo-
or patients presenting solely with distress.
OBJECTIVES: The aim of this study was to test the
effectiveness of a telephone-based close monitoring pro-
gram to manage PC patients with minor depression or
DESIGN: Subjects were randomly assigned to either the
control arm (usual care; UC) or the intervention arm
(close monitoring; CM). We hypothesized that those
randomized to CM would exhibit less depression and
be less likely to have symptoms progress to the point of
meeting diagnostic criteria.
SUBJECTS: Overall, 223 PC subjects with minor depres-
sion or distress consented to participation in this trial.
MEASUREMENTS: At baseline, subjects completed a
telephone-based evaluation comprised of validated diag-
nostic assessments of depression and other MH dis-
orders. Outcomes were assessed at six months utilizing
this same battery. Chart reviews were conducted to
track care received, such as prescribed antidepressants
and MH and primary care visits.
RESULTS: Subjects in the CM arm exhibited fewer psy-
chiatric diagnoses than those in the UC arm (χ2=4.04,
1 df, p=0.04). Inaddition, the intervention group showed
improved overall physical health (SF-12 PCS scores)
(M=45.1, SD=11.8 versus M=41.5, SD=12.4) (χ2=5.90,
1 df, p=.02).
CONCLUSIONS: Those randomized to CM exhibited
less MH problems at the conclusion of the trial, indi-
cating that the close monitoring program is effective,
feasible and valuable. The findings of this study will
allow us to enhance clinical care and support the
integration of mental health services and primary care.
KEY WORDS: minor depression; close monitoring; telephone care
J Gen Intern Med 23(9):1379–85
© Society of General Internal Medicine 2008
While major depression has been widely researched, leading to
the establishment of clear treatment guidelines, there has
been less consistent research on the treatment of minor and
subsyndromal forms of depression. Minor and subsyndromal
depression are almost twice as common in primary care (PC) as
major depression,1–3leading to greater health care utilization4
and increased dysfunction and disability,5–7and putting
patients at risk for the development of major depressive
disorder.8Although findings on the morbidity associated with
low levels of depression4,5,9,10suggest the potential value of
treatment, no evidence-based guidelines have been estab-
lished11. Thus, when PC clinicians encounter patients with
depression or distress, they perceive themselves as forced to
make a series of binary choices, such as whether or not to
prescribe antidepressants or make an MH referral. Moreover,
given stringent time demands and limited resources, they often
perceive themselves as having to make these choices on the
basis of inadequate information.11
The challenge facing PC clinicians is made even more
difficult by a lack of evidence about the optimal approach to
treating patients with milder forms of depression. While some
trials have shown pharmacotherapy to be efficacious for
improving depressive symptoms,12,13others have shown no
significant differences between response to placebo and active
treatment.4Psychotherapy interventions implemented in pri-
mary care, such as problem solving therapy, have received
uneven support with substantial variability among studies.13,14
These potentially conflicting findings have led to recommen-
dations for a period of close monitoring (CM) before treatment
of minor depression, with the initiation of treatment reserved
for individuals who have persistent and/or disabling symptoms.
Such a period would avoid exposure to potential side effects and
risks of active treatment for patients whose symptoms would
remit spontaneously. However, recommendations for close
monitoring have been primarily post hoc suggestions, offered
in discussions of findings from randomized clinical trials.13
Received November 5, 2007
Revised April 3, 2008
Accepted May 1, 2008
Published online May 23, 2008
4. Johnson J, Weissman MM, Klerman GL. Service utilization and social
morbidity associated with depressive symptoms in the community.
5. Judd LL, Paulus MP, Wells KB, et al. Socioeconomic burden of
subsyndromal depressive symptoms and major depression in a sample
of the general population. Am J Psychiat. 1996;153:1411–7.
6. Rapaport MH, Judd LL. Minor depressive disorder and subsyndromal
depressive symptoms: functional impairment and response to treatment.
J Affect Disord. 1998;48:227–32.
7. Wells KB, Stewart A, Hays RD, et al. The functioning and well-being of
depressed patients. Results from the medical outcomes study. JAMA.
8. Chopra MP, Zubritsky C, Knott K, et al. Importance of subsyndromal
symptoms of depression in elderly patients. Am J Geriatr Psychiatry.
9. Barrett JE, Barrett JA, OXman TE, et al. The prevalence of psychiatric
disorders in a primary care practice. Arch Gen Psychiatry. 1988;45:
10. Broadhead WE, Blazer DG, George LK, et al. Depression, disability
days, and days lost from work in a prospective epidemiologic survey.
11. Ackermann RT, Williams JW Jr. Rational treatment choices for non-
major depressions in primary care: an evidence-based review. J Gen
Intern Med. 2002;17:293–301.
12. Judd LL, Rapaport MH, Yonkers KA, et al. Randomized, placebo-
controlled trial of fluoxetine for acute treatment of minor depressive
disorder. Am J Psychiatry. 2004;161:1864–71.
13. Williams JW Jr, Barrett J, Oxman T, et al. Treatment of dysthymia and
minor depression in primary care: A randomized controlled trial in older
adults. J Am Med Assoc. 2000;284:1519–26.
14. Katon W, Russo J, Frank E, et al. Predictors of nonresponse to
treatment in primary care patients with dysthymia. Gen Hosp Psychia-
15. Oslin DW, Sayers S, Ross J, et al. Disease management for depression
and at-risk drinking via telephone in an older population of veterans.
Psychosom Med. 2003;65:931–7.
16. Felker BL, Chaney E, Rubenstein LV, et al. Developing effective
collaboration between primary care and mental health providers. Prim
Care Companion J Clin Psychiatry. 2006;8:12–6.
17. Oslin DW, Ross J, Sayers S, et al. Screening, assessment, and
management of depression in VA primary care clinics, The Behavioral
Health Laboratory. J Gen Intern Med. 2006;21:46–50.
18. Oslin DW, Rowland ES, Difilippo S, et al. Behavioral Health Laboratory:
Manuals of Operations: Volumes 1-6 (v2).. Philadelphia: Philadelphia
Veterans Affairs Medical Center; 2007.
19. Kawas C, Karagiozis H, Resau L, et al. Reliability of the blessed
telephone information-memory-concentration test. J Geriatr Psychiat
20. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief
depression severity measure. J Gen Intern Med. 2001;16:606–13.
21. Sheehan DV, Lecrubier Y, Sheehan K, et al. The Mini-International
Neuropsychiatric Interview (M.I.N.I): The development and validation of a
structured diagnostic psychiatric interview for DSM-IV and ICD-10. J
Clin Psychiatry. 1998;59:22–33.
22. Sobell LC, Brown J, Leo GI, et al. The reliability of the alcohol timeline
followback when administered by telephone and by computer. Drug
Alcohol Depend. 1996;42:49–54.
23. Paykel ES, Myers JK, Lindenthal JJ, et al. Suicidal feelings in the
general population: a prevalence study. Br J Psychiatry. 1974;124:
24. Ware J, Kosinski M, Keller S. A 12-item Short-form Health Survey:
construction of scales and preliminary tests of reliability and validity.
Med Care. 1996;32:220–33.
25. Bruce ML, Ten Have TR, Reynolds CF 3rd, et al. Reducing suicidal
ideation and depressive symptoms in depressed older primary care
patients: a randomized controlled trial. J Am Med Assoc. 2004;291:
26. Datto C, Miani M, Disbot M, et al. Preliminary analysis of telephone
disease management for depression in primary care in NIMH Mental
Health Services Research, Washington, DC; 2000.
27. Joffe M, Small D, Hsu C. Defining and estimating intervention effects for
groups who will develop an auxiliary outcome. Stat Sci. 2007;22:74–97.
Ross et al.: Close Monitoring for Mild Depressive Symptoms