DepressionAniMovilNCT03615118
AniMovil mHealth Support for Depression Management in a Low-Income Country
A study testing IVR/SMS and SMS in people with Depression, run by University of Michigan at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- IVR/SMS and SMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2018to 9 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A score of 10+ on the Spanish-validated version of the PHQ-9
Who cannot join
- Less than a 6-month life expectancy
- A history of psychiatric hospitalization or bipolar disorder
- A substance use disorder or cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression
- Being tested
- IVR/SMS, SMS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR/SMSOther
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
SMSOther
Daily SMS messages asking participants to report their mood on a 1 to 9 scale
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: IVR/SMS |
| Enhanced Usual Care | Active comparator | 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. Receives: Other: SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in PHQ scores at Baseline and 3 month follow-up
Secondary outcomes (3)
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.
Measured: Change in SF12 score at Baseline and 3 month follow-up
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.
Measured: Change in score at Baseline and 3 month follow-up
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.
Measured: Changes in Daily mood scores between days 1-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Aug 2018
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Los Andes, Bogota, Colombia
- Responsible party
- Principal investigator, John Piette, University of Michigan
- Investigators
- John Piette, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615118
- Sponsor's protocol ID
- 15-PAF05075
- Acronym
- AniMovil
- Status last verified
- Jan 2020
- First submitted
- 13 Jul 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AniMovil mHealth Support for Depression Management in a Low-Income Country
- ClinicalTrials.gov ID
- NCT03615118
- Acronym / sponsor ID
- AniMovil / 15-PAF05075
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Universidad de Los Andes, Bogota, Colombia
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: IVR/SMSPatients 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. |
| Enhanced Usual Care | Active comparator | Other: SMSEnhanced 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A score of 10+ on the Spanish-validated version of the PHQ-9
Key exclusion criteria (3 listed)
- Less than a 6-month life expectancy
- A history of psychiatric hospitalization or bipolar disorder
- A substance use disorder or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR/SMSDaily 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 | Intervention |
| SMSDaily SMS messages asking participants to report their mood on a 1 to 9 scale | Other | Enhanced Usual Care |
Primary outcome
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.
3 secondary outcomes
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
Sheehan Disability Scale (SDS)
Time frame: Change in score at Baseline and 3 month follow-up
Daily mood ratings
Time frame: Changes in Daily mood scores between days 1-90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Piette, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR/SMS and SMS in people with Depression, run by University of Michigan at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.