Chinese Americans who screen positive for depression in participating primary care clinics will be called by research assistants. Eligible and interested patients will then be randomized into one of two groups. Those in the T-CSCT group will receive telepsychiatry-based Culturally Sensitive Collaborative Treatment (T-CSCT) from a multidisciplinary team, while patients in the Usual Care (UC) group will continue to receive treatment as usual from their PCPs alone. The proposed sample size is 60 patients in each group. However, anticipating a dropout rate of 20%, we aim to have at least 48 patients in each group complete all study procedures through the final week of the study.
Description of T-CSCT Intervention
The T-CSCT intervention involves two major components:
1)T-CSCT assessment: Patients in the T-CSCT group will undergo a telepsychiatry-based culturally sensitive psychiatry assessment by a bilingual psychiatrist using the Engagement Interview Protocol (EIP), described above. Patients in the UC arm will also undergo the initial telepsychiatry-based assessment with a psychiatrist, but this assessment will not utilize the EIP.
2) Care management: The goal of care management is to monitor patients' psychiatric treatment as well as to consolidate and streamline the treatment efforts of the patient's PCP and psychiatrist. Via regularly scheduled phone visits with patients, bilingual care managers will monitor the following: patients' depressive symptoms, adherence to the MDD treatment protocol that their doctor(s) recommended, adverse events (for patients taking antidepressant medications), and patients' self-management of their depression. Care managers are accessible to patients through telephone contact or videoconferencing for questions on depression and medication, and they also can provide culturally sensitive interpretations of patients' symptoms and their treatment for depression. They serve as a link between the patient, PCP, and the consulting psychiatrist.
The first care management interview is a face-to-face meeting with a bilingual care manager to establish rapport and to explain the roles of care manager and blind assessor (see below for details on the blind assessments), as well as to review the patient's course of illness and provide an explanation of MDD and how it can be treated.
Subsequent visits will take place via telephone at seven scheduled points throughout the study (see Table ), but care managers will make additional phone calls if deemed clinically necessary and/or helpful to patients. During each phone visit, patients' depressive symptoms will be monitored using the CB-PHQ-9. When modification in treatment is needed, the care manager will send a report to patients' PCPs with recommendations from the study psychiatrist, who will provide weekly supervision to care managers. The study psychiatrist will be available for consultation via videoconference if requested by patients, care managers, or patients' PCPs. Care managers will encourage PCPs to consider the reports on the updates of patients' conditions when deciding whether to modify patients' treatment, and they will support PCPs in implementing these recommendations. Patients who do not respond to treatment by week 10 and those who have more complicated psychiatric illnesses (e.g., psychiatric comorbidities, past treatment failures) will be encouraged to have an additional psychiatric consultation via videoconferencing.
Timeline for Administration of Instruments by the Care Manager
For patients who are receiving concurrent treatment from their PCPs, care managers will assist in scheduling follow-up visits at approximately weeks 1, 3, 6, 10, 16, and 22 of the study in order for PCPs to monitor patients' treatment response, titrate medication dosages, and manage side effects of the medications.
Assessment by Blind Interviewers
Patients in both the intervention and usual care groups will be assessed by a bilingual blinded interviewer via phone call every six weeks throughout the six-month duration of the study. Patients receiving treatment from their PCPs will be assessed on their adherence to treatment as well as medication side effects (if applicable).
Patients will be included if they 1) are monolingual Chinese Americans, meaning that they require or prefer to be interviewed in Chinese (Cantonese or Mandarin), 2) are 18 years of age or older, 3) are competent to consent to study participation, 4) meet criteria for MDD as diagnosed by the Mini International Neuropsychiatric Interview (MINI) [19
], 5) receive a score of 10 or greater on the CB-PHQ-9, and 6) are willing to participate in phone interviews for symptom monitoring, as well as for care management if they are randomized to the treatment group.
Patients will be excluded if they 1) present with serious suicidal risk, 2) have an unstable medical illness requiring imminent hospitalization, 3) have comorbid severe mental disorders (e.g., schizophrenia, substance abuse, bipolar disorder), or 4) have been treated by a psychiatrist within the past four months.
The study will be conducted in collaboration with PCPs at the South Cove Community Health Center (hereafter South Cove), one of the largest community health centers for Chinese Americans in the Boston area. Although we expect that most patients who enroll in the study will have PCPs at South Cove, patients who do not have South Cove PCPs will still be allowed to enroll.
Both the patients who screen positive as well as their PCPs will be informed about their screening outcomes. The PCPs of enrolled patients in both groups will be provided information about the study and must assent to treating their depressed patients who are enrolled in the study in the context of T-CSCT.
At the beginning of the study, PCPs at South Cove will attend education sessions where study staff will explain study procedures, discuss depression treatment based on the Agency for Health Care Policy and Research (AHCPR) guidelines [20
], and answer any questions. PCPs who work outside of South Cove will not have the training sessions. The PCPs of patients in both the intervention and usual care arms will be notified when their patients have enrolled in the study.
In contrast to the protocol for the original CSCT study [2
] on which the current study's protocol is based, patients in the current study will be provided only with consultations, but not with continued treatment, from the study psychiatrists. We hope that by controlling for extraneous aspects of patients' treatment that is unrelated to the treatment they receive as part of the study, differences in the outcomes between the usual care and intervention arms will be more prominent.
PCPs will be advised to schedule follow-up visits with the study patients at weeks 1, 3, 6, 10, 16, and 22 of the study. For patients in the T-CSCT group, the care manager will remind and assist patients in setting up these appointments; patients in the control group will set up their own appointments.
Target Health Condition
All patients in the intervention and control arms will be recruited from patients in primary care using the PHQ-9; patients with scores of 10 or greater will be considered to have screened positive for depression.
Subjects will be recruited primarily through depression screening at the three primary care clinics of South Cove, and through advertisements. Advertisements for the research study will be placed in community primary care clinics as well as in high-traffic areas in the Chinese community, in local Chinese newspapers, and on the Internet. Participants will also be recruited through referrals from primary care doctors. Research staff will distribute copies of the CB-PHQ-9 to patients in primary care clinics. Patients who score at or above a 10 on this assessment will be encouraged to call a research assistant or give the form to a nurse, who will send it to a research assistant; the RA will then contact the patient directly.
Definition of Usual Care (UC)
PCPs of the patients who are randomized to UC will be informed that their patient is participating in the study and that the patient has depression. Patients will not receive protocol-driven collaborative care management; however, they may seek psychotherapy and/or psychopharmacological consultation, including a telepsychiatry-based consultation from the study psychiatrist.
Human Subjects Approval
All study procedures have been approved by the Institutional Review Board (IRB) of the Partners HealthCare System.