NCT03615118: AniMovil

AniMovil mHealth Support for Depression Management in a Low-Income Country

Completed NA Last updated 5 February 2020

What this trial tests

NA trial testing IVR/SMS in Depression in 114 participants. Completed in 9 December 2019.

Timeline

1 August 2018

Primary endpoint
9 December 2019

9 December 2019

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	114
Start date	1 August 2018
Primary completion	9 December 2019
Estimated completion	9 December 2019
Sites	1 location across Colombia

Drugs / interventions tested

• IVR/SMS
• SMS

Conditions studied

• Depression — all drugs for Depression →

Sponsor

University of Michigan

Who can join

Adults 21 to 60, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.