Depression
Conditions
Brief summary
Depression is a huge public health problem in low and middle-income countries (LMICs). Mental health care systems in most LMICs are extremely limited, impeding the dissemination of WHO-recommended models for improving care via task-shifting services to community health workers (CHWs) who deliver evidence-based treatments such as cognitive behavioral therapy (CBT). This comprehensive intervention will use IVR and text messaging (SMS) to support effective depression care. Intervention patients will receive weekly automated (IVR) calls and daily text messages (SMS) throughout the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery. Patients will be enrolled from Colombian clinics associated with the Universidad de Los Andes in Bogota, Colombia. 114 patients will be randomized to either a usual enhanced care or intervention group. Intervention group patients will receive weekly automated (IVR) calls and daily text messages throughout the duration of the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery. Program components will be modified to fit the local culture and clinical environment via iterative engagement of health professionals and patients with depression. Those patients in usual enhanced care will receive the study manual and daily text messages and feedback throughout the duration of the program. Patients in the enhanced usual care group who present with more severe depression will be referred to the national program office for depression services support - a free service available to all citizens diagnosed with depression.
Interventions
OTHERIVR/SMS
Daily SMS messages asking participants to report their mood on a 1 to 9 scale; An automated phone system for monitoring and improving self-care and health outcomes
OTHERSMS
Daily SMS messages asking participants to report their mood on a 1 to 9 scale
Sponsors
Universidad de Los Andes, Bogota, Colombia
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* A score of 10+ on the Spanish-validated version of the PHQ-9
Exclusion criteria
* Less than a 6-month life expectancy * A history of psychiatric hospitalization or bipolar disorder * A substance use disorder or cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of depression symptoms, as measured by Patient Health Questionnaire, 9 item (PHQ9) | Change in PHQ scores at Baseline and 3 month follow-up | Depressive symptom severity. Min score=0, Max score=27. 0=not depressed, 27=severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life as measured by Short Form Survey (SF12) | Change in SF12 score at Baseline and 3 month follow-up | The SF-12 is composed of 12 questions, selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The 12 questions are combined, scored, and weighted, assessing mental and physical functioning and overall health-related-quality of life. |
| Sheehan Disability Scale (SDS) | Change in score at Baseline and 3 month follow-up | The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. 0=not at all, 1-3=mild, 4-6=moderate, 7-9=marked, 10=extremely. Total score 0-30 (0 unimpaired, 30 highly impaired). Questions are broken into 3 assessed categories: Work/school (0-10); Social life (0-10); Family life/home responsibilities (0-10). Scoring: Scores of ≥5 on any of the 3 scales indicate a high score, and high scores are associated with significant functional impairment. |
| Daily mood ratings | Changes in Daily mood scores between days 1-90 | Daily mood rating on a 1-9 scale reported via SMS. Daily mood score of 1 indicates a low mood, where as 9 indicates a high or positive mood. |
Countries
Colombia
Outcome results
None listed