The purpose of this pilot study is the development and preliminary evaluation of an automated telecommunications system to help adult patients with unipolar depression improve adherence to their antidepressant medication regimens and scheduled office visits with their mental health care providers. Based on Social Cognitive Theory (SCT), particularly its self-efficacy construct, the Telephone-Linked Care for Adherence to Treatment Regimen in Depression (TLC-Depression) will automatically monitor adherence to treatment regimens as well as disease symptoms and functional status of patients and will give information, advice and counseling to patients to reinforce adherence. TLC-Depression will also generate reports from the information obtained from the patients and will communicate it to their mental health caregivers in order to assist the responsible physician in better monitoring of the patients medication-taking behavior, their depression symptoms and their functioning. The study will entail 2 components: 1) A qualitative evaluation of TLC-Depression that will be carried out with a maximum of 20 patients with the purpose of modification and refinement of the system. These patients will be screened for a period of 1 month to determine eligibility (medication adherence as measured by MEMS track caps less than 80 percent, and pill count audit). In-Depth interviews will be conducted twice a month with eligible subjects who will use TLC-Depression for 2 months. The results of the interviews will be utilized to improve and refine the intervention. 2) A quantitative pilot study to test TLC-Depression in order to utilize the system in a future randomized clinical trial with sufficient power to evaluate its efficacy. Sixty eligible patients will be randomized to the intervention (TLC) and usual care (UC) groups for a period of 4 months. All patients will be screened for a 1-month period to determine adherence eligibility (medication adherence as measured by MEMS track caps less than 80 percent, and pill count audit). Patients will call TLC-Depression and will converse with the system through the touch-tone keypad on their telephones. Patients will call TLC-Depression once a week at a scheduled time. The analysis will compare TLC and UC patients between baseline and follow-up 4 months later. Patients' self-efficacy, psychological and physical health status will be measured at baseline and at the end of the study. We hypothesize that TLC Depression will improve adherence, self-efficacy and psychological and physical health status among patients in the intervention group over a 4-month period in comparison with those in the control group. And that TLC-Depression will be acceptable and usable by the patients
