AniMovil mHealth Support for Depression Management in a Low-Income Country
NCT ID: NCT03615118
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2018-08-01
2019-12-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
Patients randomized to the intervention group will receive the AniMóvil intervention, including: the Sentirse Mejor manual that patients can refer to for information about CBT and skill practice, weekly IVR depression symptom assessments and psychoeducational messages, daily SMS mood monitoring and CBT reinforcement messages, and CHW telephone CBT sessions in the event of elevated PHQ-9 scores during the study. CHWs will use information from patients' IVR/SMS monitoring to support intervention-group patients' depression self-management under close supervision from their mental health specialist supervisor. Intervention patients will be part of a 'stepped' intervention based on the severity of their depression upon entry into the program and assessment throughout the intervention.
IVR/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
Enhanced Usual Care
Enhanced usual care patients will receive usual care, including the Sentirse Mejor manual developed by the research team in conjunction with local Ministries of Mental Health and tailored by the study team, emphasizing CBT principles, and daily SMS messages asking participants to report their mood on a 1 to 9 scale. Enhanced usual care group patients who report mood scores of 1 or 2 (worst scores) for at least 3 days per week and 3 consecutive weeks will be called by the Community health worker and referred to the national program office for depression services support - a free service available to all citizens diagnosed with depression. Enhanced usual care patients will be part of a 'stepped' program based on the severity of their depression upon entry into the program and assessment throughout the intervention.
SMS
Daily SMS messages asking participants to report their mood on a 1 to 9 scale
Interventions
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IVR/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
SMS
Daily SMS messages asking participants to report their mood on a 1 to 9 scale
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* A history of psychiatric hospitalization or bipolar disorder
* A substance use disorder or cognitive impairment
21 Years
60 Years
ALL
No
Sponsors
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Universidad de Los Andes, Bogota, Colombia
UNKNOWN
University of Michigan
OTHER
Responsible Party
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John Piette
VA Senior Research Career Scientist and Professor of Health Behavior Health Education, Public Health
Principal Investigators
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John Piette, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Hospital San Jose
Bogotá, , Colombia
Countries
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Other Identifiers
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15-PAF05075
Identifier Type: -
Identifier Source: org_study_id
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