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

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ClinicalTrials.gov Identifier: NCT03615118
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
Universidad de Los Andes, Bogota, Colombia
Information provided by (Responsible Party):
John Piette, University of Michigan

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03615118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AniMovil mHealth Support for Depression Management in a Low-Income Country
Official Title  ICMJE AniMovil mHealth Support for Depression Management in a Low-Income Country
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Depression
Intervention  ICMJE
  • 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
  • Other: SMS
    Daily SMS messages asking participants to report their mood on a 1 to 9 scale
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: IVR/SMS
  • Active Comparator: 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.
    Intervention: Other: SMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2018)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicolle Marinec, MPH 7084712334 stecn@med.umich.edu
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03615118
Other Study ID Numbers  ICMJE 15-PAF05075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Piette, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Universidad de Los Andes, Bogota, Colombia
Investigators  ICMJE
Principal Investigator: John Piette, PhD University of Michigan
PRS Account University of Michigan
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP