Methods
Study Sites and Participants
There were 2 study sites: 1 family practice clinic located in a midsize midwestern city and another located in a small town 17 miles from that city. Together they served 28,000 unique patients (56,000 visits per year); approximately 70% of these patients were aged between 18 and 65 years.
Patients were eligible for participation in our study if they met the age criteria for the study (18 to 65 years) and had a written diagnosis of depressive disorder on a clinic encounter form between March 10, 1995, and July 15, 1996. Most patients were diagnosed with “depression, not otherwise specified.” Patients with encounter diagnoses or a PCP report of bipolar I disorder, psychotic depression, mental retardation, or dementia were excluded.
Encounter forms were completed by either a clinic PCP or a psychiatrist who evaluated a small number of patients referred by clinic PCPs. The encounter forms listed the diagnoses given and procedures performed during the visit, and formed the basis of the clinics’ administrative data sets.
Patient Enrollment and Data Collection
A research associate contacted the PCPs of eligible patients identified through encounter forms and requested permission to recruit their patients. If the PCPs gave permission, their patients received a letter followed by a telephone call requesting participation. Patients identified through the psychiatrist were referred directly to research staff for recruitment.
Participants were interviewed by the research associate using the Primary Care Evaluation of Mental Disorders questionnaire (PRIME-MD), a 2-step screening and diagnostic instrument. The patients also completed the baseline assessment from the Depression Outcomes Modules (DOM) 8.1,13,14 the Symptom Check List-25 (SCL-25),15-17 the Alcohol Use Disorders Identification Test (AUDIT),18,19 and answered questions about their use of mental health services. They were mailed follow-up assessments approximately 5 months after study entry, including the follow-up module from the DOM 8.3. Nonrespondents received up to 3 follow-up mailings and 1 telephone call from a study staff member. Only assessments completed between 5 and 12 months postenrollment were included in the study.
We conducted a focused chart review to determine the dates when patients were first seen in the study clinics, when they first had chart notations of depression, and whether antidepressant medication was prescribed.
Measures
The DOM 8.1 and 8.3 include questions about the presence, severity, and duration of depressive symptoms, prognostic factors, the presence or absence of 20 concurrent medical conditions, mental health services use, and health-related functional status.13,14 The DOM also includes the Medical Outcomes Study (MOS) Short Form-36 (SF-36) which assesses health status in 8 domains: physical functioning, role limitations due to physical conditions, bodily pain, general health perceptions, vitality, role limitations due to emotional conditions, social functioning, and mental health.
The AUDIT consists of 10 items and screens for alcohol-related problems,18,19 and the SCL-25 collects information about the presence and severity of anxiety and depressive symptoms.15-17 The PRIME-MD screens for 5 common categories of mental health disorders in primary care (mood disorders, anxiety disorders, somatoform disorders, eating disorders, and alcohol abuse) and then uses a semistructured interview to make a Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis.20
We excluded somatoform disorders from consideration, since the PRIME-MD diagnostic instrument requires the interviewer to use clinical judgment to decide if somatic symptoms have a physical explanation “sufficient to explain their severity and associated disability.” The research associate completing the PRIME-MD was not in a position to make these judgments.
All of the study instruments have satisfactory reliability and validity in primary care as demonstrated by test-retest reliability,14,17 internal consistency of subscales,14,19 concurrent validity,14,18-21 or construct validity.14,18,20,22
Data Analysis
We conducted descriptive analyses for the 103 eligible patients who enrolled in the study and 83 patients who returned follow-up assessments.
Bivariate analyses were done to evaluate differences between eligible patients who enrolled or did not enroll and between enrolled patients who did or did not return follow-up data. We used Student t tests for continuous variables and chi-squares for dichotomous or categorical variables.
We examined differences between baseline and follow-up SCL and SF-36 scores using paired t tests. The effect sizes of changes in SF-36 scores were calculated as suggested by Kazis and colleagues23 by dividing the change score for each scale by the standard deviation of the scale at baseline. The percentages of patients who improved, remained the same, or worsened on each scale were calculated using the criterion for change of at least 1 standard error of measurement, as described by Wolinsky and coworkers.24
Using multivariate analyses, we explored factors that might be associated with patient improvement. Outcome variables were change scores for the SCL depression scale and SF-36 Mental Health scale, and predictors were age, sex, presence of chronic depression, number of concurrent medical conditions, concurrent mental health care at enrollment, antidepressant medication during follow-up, and baseline SCL depression or SF-36 mental health scores. The number of concurrent medical conditions and the presence of a chronic depression were ascertained from responses to DOM questions.