DepressionPhase 3Latin-MHNCT02846662
Effectiveness of a Mobile Technology Intervention for the Treatment of Depression
A Phase 3 study testing CONEMO in people with Depression and Diabetes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Background: Depression is a usual comorbid event associated to chronic diseases, such as hypertension and diabetes, constituting an important public health problem, with negative consequences for patients' quality of life and self-care, as well as for compliance with medical treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression, Diabetes, Hypertension
- What is being tested?
- CONEMO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Sep 2016to 31 Aug 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending one of 20 selected primary care clinics
- Clinical diagnosis of diabetes and/or hypertension
- Presenting with depressive symptoms (PHQ-9 ≥10)
Who cannot join
- Moderate to high suicidal risk (assessed with a standardized protocol)
- Not able to read
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 01246-903
About this study
Official title: Randomized Clinical Trial to Evaluate the Effectiveness of an Intervention Using Mobile Technology for the Treatment of Depressive Symptoms in People With Diabetes or Hypertension
Background: Depression is a usual comorbid event associated to chronic diseases, such as hypertension and diabetes, constituting an important public health problem, with negative consequences for patients' quality of life and self-care, as well as for compliance with medical treatment. In low and middle income countries depression is often unrecognized and untreated, and there is a lack of human resources to treat depression and other mental problems in these health care systems.
Aim: The present study aims to test a 6 week low-intensity psychological intervention (CONEMO) delivered via an applicative for smartphones for people with depressive symptoms and co-morbid diabetes and/or hypertension recruited in primary health care units, in São Paulo (Brazil).
Read the detailed description
Epidemiologic research has clearly established the significant public health importance of mental disorders in low- and middle-income countries (LMIC) and their chronic nature. Among mental disorders, depression has become a major problem as a single condition and, more often, as part of complex clinical pictures in which multiple conditions and risk factors are combined.
There is substantial co-morbidity between depression and chronic physical conditions, and outcome of both conditions is impaired when there is this co-morbidity. Most of the disease burden in LA is now explained by chronic diseases, including depression, cardio-vascular diseases -mostly hypertension related- and diabetes. Despite the public health impact of depression, it often goes unrecognized and untreated. One factor for this treatment gap is the lack of financial and human resources. The limited mental health resources available in LMIC are often not optimally distributed either. Funds and trained personnel are typically allocated in tertiary health care services, such as psychiatric hospitals.
Therefore, any short- and medium-term efforts to develop, evaluate, and disseminate effective mental health interventions in LMIC must adapt to these severe workforce, resource limitations, and inequities. The mental health field needs to consider developing self-help automated interventions that can reach people where there are no health care providers. This can be partially addressed through two strategies: 1) increasing effective self-management; and 2) through task-shifting roles to less specialized but appropriately trained health workers.
We are conducting a community cluster randomized trial with individuals with chronic diseases (hypertension and/or diabetes) and symptoms of depression, attending primary care clinics in São Paulo, Brazil. Participating clinics (20) will be randomly allocated to have their nurse assistants trainned and supervised to monitor an intervention based on behavior activation (experimental group) delivered by an applicative for smartphones (CONEMO) or to receive routine care (control group). The focus of this project is on patients helping themselves through the use of resources that provide continuous advice, support, and motivation. However, studies suggest that depressed patients left alone with their own devices fail to make good use of self-help interventions. Nurse assistants will assist participants by a web-based automated interface connected to the smartphone application (CONEMO) and will receive supervision in this task once a week.
Method:
CONEMO is a cluster randomized controlled trial conducted with 880 chronic patients who present diabetes and/ or hypertension and with depression, receiving health care in 20 Primary Care Units with Family Health Program in Sao Paulo, Brazil. Of these, half (10) will deliver the intervention CONEMO and half (10) will deliver usual care.
The intervention, based in behavior activation, is delivered by a smartphone and monitored by health professionals (nurse assistants) working at the primary care unit responsible for the care of the patient. The CONEMO intervention is based on behavior activation and is delivered by an applicative for smartphones 3 times a week during 6 weeks, with a total of 18 sessions. A nurse assistant mediates this intervention, motivating the patient and monitoring his/her performance. Intensity of depressive symptoms and suicidal ideation is assessed by research assistants using the PHQ-9 and standardized protocols for suicidal risk at baseline, 3- and 6-month follow-ups.
The primary outcome is remission of depressive symptoms 3 months after inclusion in the study. Secondary outcomes include remission of depressive symptoms at 6 months after inclusion, social support, quality of life, compliance to medication, suicidal ideation and activities performed.
The effectiveness and cost-effectiveness of the intervention will be assessed with intention-to-treat analysis, using the clinical outcome and the assessment of quality of life (EQ-5D) 3 and 6 months after inclusion in the trial and the use of health services.
Primary Outcome Measures:
Patient Health Questionnaire (PHQ-9) score 3 months after inclusion in the study.
A 50% reduction in the PHQ-9 score from baseline will be considered success.
Secondary Outcome Measures:
Depression - Patient Health Questionnaire (PHQ-9), Quality of life-EQD5, Adherence to medication-Morisky; Social functioning- WHODAS, Daily activities (BADS).
Time Frame: 6 months after inclusion in the study. A 50% reduction on the PHQ-9 score from baseline will be considered success.
Cost effectiveness measures (3 and 6 months). Use of health services and medication. General Quality of life (EQ-5D).
Process evaluation:
Data collected in the interviews with participants and Nurse Assistants about CONEMO system.
- Conditions
- Depression, Diabetes, Hypertension
- Being tested
- CONEMO
- Keywords
- depression, mobile technology, community trial
- Medical subject headings
- Depression, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONEMOBehavioural
The study intervention has two components: the smartphone application CONEMO and primary care nurses monitoring patients' adherence to the intervention. CONEMO is a 6-week low-intensity behavior activation program delivered in 18 sessions that include messages related to the treatment goals, motivating them to do certain activities, helping to select and plan activities and messages related to psychological skills that facilitate the incorporation of activities in everyday life and to tackle obstacles that hinder patients to be more active. Primary care nurses are responsible for training participants to use the CONEMO app, monitoring patients' adherence to CONEMO, calling patients when they are non-adherent, and giving technical support when necessary.
| Study group | Role | What they receive |
|---|---|---|
| CONEMO | Experimental | Participants will be offered a behavioral activation-based intervention delivered by an applicative for smartphones (CONEMO), which encourages them to be more active and to incorporate more activities in their everyday life.
Primary care nurses will train participants to use the CONEMO app, monitor patients' adherence to CONEMO, calling patients when they are non-adherent, and give technical support when necessary. They will be supervised by clinical psychologists.
Primary care teams are informed of participants' depression level and deliver usual care according to clinical protocols, including the assessment for the need of antidepressant medication. Receives: Behavioral: CONEMO |
| ENHANCED USUAL CARE | No intervention | The primary care teams are informed of the participants' depression level and can deliver usual care according to clinical protocols, including the assessment for the need of antidepressant medication. This is considered enhanced usual care because the teams are notified about participants' level of depressive symptomatology, which otherwise might go undetected, and then decide about the best way to handle with patients' needs related to their depressive symptomatology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 50% reduction in PHQ-9 score a 3-month assessment
Presence and severity of depressive symptoms is measured with the PHQ-9. A 50% reduction in PHQ-9 score at 3-month assessment as compared to PHQ-9 score at baseline will be considered as treatment success.
Measured: 3 months after enrollment
Secondary outcomes (5)
Number of participants with 50% reduction in PHQ-9 score a 6-month assessment
Presence and severity of depressive symptoms is measured with the PHQ-9. A 50% reduction in PHQ-9 score at 6-month assessment as compared to PHQ-9 score at baseline will be considered as treatment success.
Measured: 6 months after enrollment
Improvement in scores for Quality of Life, as measured by the EQD5
Quality of life is measured with the EQ-5D, a standardized instrument that investigates 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: 3 and 6 months after enrollment
Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire
proportion of patients who improve adherence to diabetes or hypertension medication 3 and 6 months after enrollment, as compared to baseline, using the Morisky Medication Adherence Scale (MMAS-4). The distribution of MMAS-4 scores according to the level of medication adherence is: High adherence (0), Medium adherence (1-2) and Low adherence.
Measured: 3 and 6 months after enrollment
Number of medical consultations, hospitalizations, and visits to the primary care team
Data on the use of health services will be collected at baseline, 3-month and six-month follow-up. At each assessment, information about medical consultations, hospitalizations, and visits to the primary care team will be obtained with a standardized questionnaire.
Measured: 3 and 6 months after enrollment
Proportion of participants who improve level of activity, as evaluated by the short form of the Behavioral Activation for Depression Scale (BADS)
Level of daily activity: assessed at baseline, 3-month, and 6-month follow-up visits using the short form of the Behavioral Activation for Depression Scale BADS. It is a 9-item scale used to measure the frequency of activation and avoidance behaviors hypothetically underlying depression mechanisms.
Measured: 3 and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start19 Sep 2016
- Primary completion31 Mar 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Universidad Peruana Cayetano Heredia, London School of Hygiene and Tropical Medicine, Northwestern University
- Responsible party
- Principal investigator, Paulo Rossi Menezes, University of Sao Paulo General Hospital
- Investigators
- Ricardo Araya, PhD, Principal investigator, London School of MedicineLisa Colpe, PhD, Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846662
- Sponsor's protocol ID
- 1U19MH098780-01 SP
- Other IDs
- 1U19MH098780-01
- Acronym
- Latin-MH
- Status last verified
- Oct 2018
- First submitted
- 31 Mar 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: One year after the end of the trial data will be available under request
Publications
Claro HG, Menezes PR, Fernandes IF, Seward N, Miranda JJ, Saidel MGB, Baquete AGL, Daley KL, Aschar S, Cruz DV, Castro HCM, Rocha T, Quayle J, Peters TJ, Araya R. Do baseline participant characteristics impact the effectiveness of a mobile health intervention for depressive symptoms? A post-hoc subgroup analysis of the CONEMO trials. Braz J Psychiatry. 2024;46:e20233172. doi: 10.47626/1516-4446-2023-3172. Epub 2024 Jan 30.
PubMed 38345934Vera Cruz Dos Santos D, Coelho de Soarez P, Cavero V, U Rocha TI, Aschar S, Daley KL, Garcia Claro H, Abud Scotton G, Fernandes I, Diez-Canseco F, Brandt LR, Toyama M, Martins Castro HC, Miranda JJ, Araya R, Quayle J, Rossi Menezes P. A Mobile Health Intervention for Patients With Depressive Symptoms: Protocol for an Economic Evaluation Alongside Two Randomized Trials in Brazil and Peru. JMIR Res Protoc. 2021 Oct 13;10(10):e26164. doi: 10.2196/26164.
PubMed 34643538Araya R, Menezes PR, Claro HG, Brandt LR, Daley KL, Quayle J, Diez-Canseco F, Peters TJ, Vera Cruz D, Toyama M, Aschar S, Hidalgo-Padilla L, Martins H, Cavero V, Rocha T, Scotton G, de Almeida Lopes IF, Begale M, Mohr DC, Miranda JJ. Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials. JAMA. 2021 May 11;325(18):1852-1862. doi: 10.1001/jama.2021.4348.
PubMed 33974019Rocha TIU, Aschar SCAL, Hidalgo-Padilla L, Daley K, Claro HG, Martins Castro HC, Dos Santos DVC, Miranda JJ, Araya R, Menezes PR. Recruitment, training and supervision of nurses and nurse assistants for a task-shifting depression intervention in two RCTs in Brazil and Peru. Hum Resour Health. 2021 Feb 5;19(1):16. doi: 10.1186/s12960-021-00556-5.
PubMed 33546709
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Effectiveness of an Intervention Using Mobile Technology for the Treatment of Depressive Symptoms in People With Diabetes or Hypertension
- ClinicalTrials.gov ID
- NCT02846662
- Acronym / sponsor ID
- Latin-MH / 1U19MH098780-01 SP
- Conditions
- Depression, Diabetes, Hypertension
- Keywords
- depression, mobile technology, community trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Universidad Peruana Cayetano Heredia, London School of Hygiene and Tropical Medicine, Northwestern University
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
Background: Depression is a usual comorbid event associated to chronic diseases, such as hypertension and diabetes, constituting an important public health problem, with negative consequences for patients' quality of life and self-care, as well as for compliance with medical treatment. In low and middle income countries depression is often unrecognized and untreated, and there is a lack of human resources to treat depression and other mental problems in these health care systems.
Aim: The present study aims to test a 6 week low-intensity psychological intervention (CONEMO) delivered via an applicative for smartphones for people with depressive symptoms and co-morbid diabetes and/or hypertension recruited in primary health care units, in São Paulo (Brazil).
Detailed description
Epidemiologic research has clearly established the significant public health importance of mental disorders in low- and middle-income countries (LMIC) and their chronic nature. Among mental disorders, depression has become a major problem as a single condition and, more often, as part of complex clinical pictures in which multiple conditions and risk factors are combined.
There is substantial co-morbidity between depression and chronic physical conditions, and outcome of both conditions is impaired when there is this co-morbidity. Most of the disease burden in LA is now explained by chronic diseases, including depression, cardio-vascular diseases -mostly hypertension related- and diabetes. Despite the public health impact of depression, it often goes unrecognized and untreated. One factor for this treatment gap is the lack of financial and human resources. The limited mental health resources available in LMIC are often not optimally distributed either. Funds and trained personnel are typically allocated in tertiary health care services, such as psychiatric hospitals.
Therefore, any short- and medium-term efforts to develop, evaluate, and disseminate effective mental health interventions in LMIC must adapt to these severe workforce, resource limitations, and inequities. The mental health field needs to consider developing self-help automated interventions that can reach people where there are no health care providers. This can be partially addressed through two strategies: 1) increasing effective self-management; and 2) through task-shifting roles to less specialized but appropriately trained health workers.
We are conducting a community cluster randomized trial with individuals with chronic diseases (hypertension and/or diabetes) and symptoms of depression, attending primary care clinics in São Paulo, Brazil. Participating clinics (20) will be randomly allocated to have their nurse assistants trainned and supervised to monitor an intervention based on behavior activation (experimental group) delivered by an applicative for smartphones (CONEMO) or to receive routine care (control group). The focus of this project is on patients helping themselves through the use of resources that provide continuous advice, support, and motivation. However, studies suggest that depressed patients left alone with their own devices fail to make good use of self-help interventions. Nurse assistants will assist participants by a web-based automated interface connected to the smartphone application (CONEMO) and will receive supervision in this task once a week.
Method:
CONEMO is a cluster randomized controlled trial conducted with 880 chronic patients who present diabetes and/ or hypertension and with depression, receiving health care in 20 Primary Care Units with Family Health Program in Sao Paulo, Brazil. Of these, half (10) will deliver the intervention CONEMO and half (10) will deliver usual care.
The intervention, based in behavior activation, is delivered by a smartphone and monitored by health professionals (nurse assistants) working at the primary care unit responsible for the care of the patient. The CONEMO intervention is based on behavior activation and is delivered by an applicative for smartphones 3 times a week during 6 weeks, with a total of 18 sessions. A nurse assistant mediates this intervention, motivating the patient and monitoring his/her performance. Intensity of depressive symptoms and suicidal ideation is assessed by research assistants using the PHQ-9 and standardized protocols for suicidal risk at baseline, 3- and 6-month follow-ups.
The primary outcome is remission of depressive symptoms 3 months after inclusion in the study. Secondary outcomes include remission of depressive symptoms at 6 months after inclusion, social support, quality of life, compliance to medication, suicidal ideation and activities performed.
The effectiveness and cost-effectiveness of the intervention will be assessed with intention-to-treat analysis, using the clinical outcome and the assessment of quality of life (EQ-5D) 3 and 6 months after inclusion in the trial and the use of health services.
Primary Outcome Measures:
Patient Health Questionnaire (PHQ-9) score 3 months after inclusion in the study.
A 50% reduction in the PHQ-9 score from baseline will be considered success.
Secondary Outcome Measures:
Depression - Patient Health Questionnaire (PHQ-9), Quality of life-EQD5, Adherence to medication-Morisky; Social functioning- WHODAS, Daily activities (BADS).
Time Frame: 6 months after inclusion in the study. A 50% reduction on the PHQ-9 score from baseline will be considered success.
Cost effectiveness measures (3 and 6 months). Use of health services and medication. General Quality of life (EQ-5D).
Process evaluation:
Data collected in the interviews with participants and Nurse Assistants about CONEMO system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONEMO | Experimental | Behavioral: CONEMOParticipants will be offered a behavioral activation-based intervention delivered by an applicative for smartphones (CONEMO), which encourages them to be more active and to incorporate more activities in their everyday life. Primary care nurses will train participants to use the CONEMO app, monitor patients' adherence to CONEMO, calling patients when they are non-adherent, and give technical support when necessary. They will be supervised by clinical psychologists. Primary care teams are informed of participants' depression level and deliver usual care according to clinical protocols, including the assessment for the need of antidepressant medication. |
| ENHANCED USUAL CARE | No intervention | –The primary care teams are informed of the participants' depression level and can deliver usual care according to clinical protocols, including the assessment for the need of antidepressant medication. This is considered enhanced usual care because the teams are notified about participants' level of depressive symptomatology, which otherwise might go undetected, and then decide about the best way to handle with patients' needs related to their depressive symptomatology. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Attending one of 20 selected primary care clinics
- Clinical diagnosis of diabetes and/or hypertension
- Presenting with depressive symptoms (PHQ-9 ≥10)
Key exclusion criteria (2 listed)
- Moderate to high suicidal risk (assessed with a standardized protocol)
- Not able to read
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 |
|---|---|---|
| CONEMOThe study intervention has two components: the smartphone application CONEMO and primary care nurses monitoring patients' adherence to the intervention. CONEMO is a 6-week low-intensity behavior activation program delivered in 18 sessions that include messages related to the treatment goals, motivating them to do certain activities, helping to select and plan activities and messages related to psychological skills that facilitate the incorporation of activities in everyday life and to tackle obstacles that hinder patients to be more active. Primary care nurses are responsible for training participants to use the CONEMO app, monitoring patients' adherence to CONEMO, calling patients when they are non-adherent, and giving technical support when necessary. | Behavioural | CONEMO |
Primary outcome
Number of participants with 50% reduction in PHQ-9 score a 3-month assessment
Time frame: 3 months after enrollment
Presence and severity of depressive symptoms is measured with the PHQ-9. A 50% reduction in PHQ-9 score at 3-month assessment as compared to PHQ-9 score at baseline will be considered as treatment success.
5 secondary outcomes
Number of participants with 50% reduction in PHQ-9 score a 6-month assessment
Time frame: 6 months after enrollment
Improvement in scores for Quality of Life, as measured by the EQD5
Time frame: 3 and 6 months after enrollment
Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire
Time frame: 3 and 6 months after enrollment
Number of medical consultations, hospitalizations, and visits to the primary care team
Time frame: 3 and 6 months after enrollment
Proportion of participants who improve level of activity, as evaluated by the short form of the Behavioral Activation for Depression Scale (BADS)
Time frame: 3 and 6 months after enrollment
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 11 Oct 2018.
- Derived from this study: PubMed 38345934Claro HG, Menezes PR, Fernandes IF, Seward N, Miranda JJ, Saidel MGB, Baquete AGL, Daley KL, Aschar S, Cruz DV, Castro HCM, Rocha T, Quayle J, Peters TJ, Araya R. Do baseline participant characteristics impact the effectiveness of a mobile health intervention for depressive symptoms? A post-hoc subgroup analysis of the CONEMO trials. Braz J Psychiatry. 2024;46:e20233172. doi: 10.47626/1516-4446-2023-3172. Epub 2024 Jan 30.
- Derived from this study: PubMed 34643538Vera Cruz Dos Santos D, Coelho de Soarez P, Cavero V, U Rocha TI, Aschar S, Daley KL, Garcia Claro H, Abud Scotton G, Fernandes I, Diez-Canseco F, Brandt LR, Toyama M, Martins Castro HC, Miranda JJ, Araya R, Quayle J, Rossi Menezes P. A Mobile Health Intervention for Patients With Depressive Symptoms: Protocol for an Economic Evaluation Alongside Two Randomized Trials in Brazil and Peru. JMIR Res Protoc. 2021 Oct 13;10(10):e26164. doi: 10.2196/26164.
- Derived from this study: PubMed 33974019Araya R, Menezes PR, Claro HG, Brandt LR, Daley KL, Quayle J, Diez-Canseco F, Peters TJ, Vera Cruz D, Toyama M, Aschar S, Hidalgo-Padilla L, Martins H, Cavero V, Rocha T, Scotton G, de Almeida Lopes IF, Begale M, Mohr DC, Miranda JJ. Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials. JAMA. 2021 May 11;325(18):1852-1862. doi: 10.1001/jama.2021.4348.
- Derived from this study: PubMed 33546709Rocha TIU, Aschar SCAL, Hidalgo-Padilla L, Daley K, Claro HG, Martins Castro HC, Dos Santos DVC, Miranda JJ, Araya R, Menezes PR. Recruitment, training and supervision of nurses and nurse assistants for a task-shifting depression intervention in two RCTs in Brazil and Peru. Hum Resour Health. 2021 Feb 5;19(1):16. doi: 10.1186/s12960-021-00556-5.
- Individual participant dataSharing planned: Yes. One year after the end of the trial data will be available under request
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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.
Ricardo Araya, PhD principal investigator
London School of Medicine
Lisa Colpe, PhD principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CONEMO in people with Depression and Diabetes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 2 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 11 Oct 2018. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with 50% reduction in PHQ-9 score a 3-month assessment (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846662, which also lists 4 linked publications.
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 11 Oct 2018.