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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 May 2016 |
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Main ID: |
NCT02765542 |
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Date of registration:
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04/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Developing Accessible mHealth Programs for Depression Management in Bolivia
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Scientific title:
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Developing Accessible mHealth Programs for Depression Management in Bolivia |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02765542 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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Bolivia
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Contacts
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Name:
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John D Piette, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 21-80 years of age
- PHQ-8 score of 10 or higher
Exclusion Criteria:
- Have diagnoses indicating a six-month life expectancy
- Prior inpatient psychiatric treatment
- Patients with probable bipolar disorder or cognitive impairment as indicated on
validated screeners
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Intervention(s)
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Other: Automated disease assessment & self-care support phone calls
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Primary Outcome(s)
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Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
[Time Frame: Baseline and 12 week post-intervention follow-up]
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Secondary Outcome(s)
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Patient qualitative feedback (qualitative questionnaire)
[Time Frame: 12 week Post-intervention follow-up]
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Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
[Time Frame: Baseline and 12 week post-intervention follow-up]
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Evaluate program feasibility (telephone call completion rates)
[Time Frame: 12 week post-intervention follow-up]
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Patient satisfaction (satisfaction questionnaire)
[Time Frame: 12 week Post-intervention follow-up]
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Secondary ID(s)
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HUM00087937
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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