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Clinical Trials/NCT03615118
NCT03615118
Completed
Not Applicable

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

University of Michigan1 site in 1 country114 target enrollmentAugust 1, 2018
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Michigan
Enrollment
114
Locations
1
Primary Endpoint
Severity of depression symptoms, as measured by Patient Health Questionnaire, 9 item (PHQ9)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
December 9, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Piette

VA Senior Research Career Scientist and Professor of Health Behavior Health Education, Public Health

University of Michigan

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

Outcomes

Primary Outcomes

Severity of depression symptoms, as measured by Patient Health Questionnaire, 9 item (PHQ9)

Time Frame: 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 Outcomes

  • Daily mood ratings(Changes in Daily mood scores between days 1-90)
  • Health related quality of life as measured by Short Form Survey (SF12)(Change in SF12 score at Baseline and 3 month follow-up)
  • Sheehan Disability Scale (SDS)(Change in score at Baseline and 3 month follow-up)

Study Sites (1)

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