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Completed

NCT Number: NCT03615118

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital San Jose

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVR/SMS

Other

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

Other

Daily SMS messages asking participants to report their mood on a 1 to 9 scale

Primary outcomes

  1. 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

  1. Health related quality of life as measured by Short Form Survey (SF12)

    Time frame: 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.

  2. Sheehan Disability Scale (SDS)

    Time frame: 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.

  3. Daily mood ratings

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Universidad de Los Andes, Bogota, Colombia

Registry information

Acronym: AniMovil

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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