Clinical trial NCT03615118: AniMovil mHealth Support for Depression Management in a Low-Income Country
Official title: AniMovil mHealth Support for Depression Management in a Low-Income Country
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Universidad de Los Andes, Bogota, Colombia
First posted: 2018-08-03
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity of depression symptoms, as measured by Patient Health Questionnaire, 9 item (PHQ9)
timeFrame: Change in PHQ scores at Baseline and 3 month follow-up
Secondary outcomes:
measure: Health related quality of life as measured by Short Form Survey (SF12)
timeFrame: Change in SF12 score at Baseline and 3 month follow-up
measure: Sheehan Disability Scale (SDS)
timeFrame: Change in score at Baseline and 3 month follow-up
measure: Daily mood ratings
timeFrame: Changes in Daily mood scores between days 1-90
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital San Jose
Study officials:
affiliation: University of Michigan
name: John Piette, PhD
role: PRINCIPAL_INVESTIGATOR
References: