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

Depression Clinical Trial

— AniMovil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615118
• Other study ID #: 15-PAF05075
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 9, 2019

Study information

• Verified date: January 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• 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

Locations

Country	Name	City	State
Colombia	Hospital San Jose	Bogotá

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Universidad de Los Andes, Bogota, Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of depression symptoms, as measured by Patient Health Questionnaire, 9 item (PHQ9)	Depressive symptom severity. Min score=0, Max score=27. 0=not depressed, 27=severe depression.	Change in PHQ scores at Baseline and 3 month follow-up
Secondary	Health related quality of life as measured by Short Form Survey (SF12)	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.	Change in SF12 score at Baseline and 3 month follow-up
Secondary	Sheehan Disability Scale (SDS)	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.	Change in score at Baseline and 3 month follow-up
Secondary	Daily mood ratings	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.	Changes in Daily mood scores between days 1-90