DepressionPhase 3LATIN-MHPeruNCT03026426
Effectiveness of a mHealth Intervention for the Treatment of Depression in People With Diabetes or Hypertension in Peru
A Phase 3 study testing CONEMO in people with Depression and Diabetes, run by Universidad Peruana Cayetano Heredia at 8 sites in Peru.
Trial summary
Background: Depression is a common comorbidity of physical chronic diseases such as diabetes and/or hypertension and constitutes an important public health problem. It correlates negatively with the patients' quality of life and self-care, as well as 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
- 432 participants
- Where
- 8 sitesPeru
- Study dates
- 24 Jan 2017to 19 Dec 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
- Age 21 or older
- Presenting depressive symptoms (PHQ9≥10)
- Clinical diagnosis of diabetes and/or hypertension
- Able to read
Who cannot join
- If pregnant, the diagnosis of hypertension or diabetes is not related to the current pregnancy
- Moderate or severe suicide risk (Level B2 or C measured by S-RAP)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Peru8 sites
Policlínico Bellavista
Callao, 07011
Policlínico Hermana María Donrose Sutmöller
Callao, 07051
Hospital Nacional Dos de Mayo
Lima, 15003
Policlínico Juan José Rodríguez Lazo
Lima, 15054
Hospital Nacional Arzobispo Loayza
Lima, 15082
Hospital Nacional Cayetano Heredia
Lima, 15102
CAP III Carabayllo
Lima, 15316
Universidad Peruana Cayetano Heredia
Lima
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of a Mobile Technology Intervention in the Treatment of Depressive Symptoms in People With Diabetes or Hypertension in Peru
Background: Depression is a common comorbidity of physical chronic diseases such as diabetes and/or hypertension and constitutes an important public health problem. It correlates negatively with the patients' quality of life and self-care, as well as compliance with medical treatment. In low- and middle-income countries depression often goes unrecognized and untreated, and there are limited human resources to treat depression and other mental problems.
Aim: The present study aims to test a 6-week low-intensity psychological intervention (CONEMO - CONtrol EMOcional) delivered by a smartphone application to people with depressive symptoms and co-morbid diabetes and/or hypertension recruited in primary health care centers and public hospitals in Lima, Peru.
Read the detailed description
Epidemiologic research has clearly established the significant public health importance of mental disorders in low- and middle-income countries (LMIC). Among mental disorders, depression has become a major problem as a single condition and, more often, as part of complex clinical settings in which multiple conditions and risk factors are combined.
There is substantial co-morbidity between depression and chronic physical conditions, and the outcome of both conditions is impaired when there is this co-morbidity. Most of the disease burden in Latin America is attributable to chronic diseases such as cardio-vascular diseases as hypertension and diabetes, as well as to mental disorders such as depression. Despite the public health impact of depression, it often goes unrecognized and untreated. One important factor for this treatment gap are the limited financial and human resources. The mental health resources available in LMIC are often not optimally distributed either. Funds and trained personnel are typically allocated to 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 shortages, resource limitations, and budgetary inequities. The mental health field needs to consider developing self-help automated interventions that can reach people where there is insufficient access to specialized health care providers. This can be partially addressed applying two strategies: 1) increasing effective self-management; and 2) task-shifting roles to less specialized but appropriately trained health workers.
The investigators are conducting a randomized controlled trial with individuals with chronic diseases, i.e. hypertension and/or diabetes, and symptoms of depression in primary health centers and hospitals in Lima, Peru. Participants will be randomly assigned to the control arm or the intervention arm. The later will receive the CONEMO intervention, monitored by nurses.
The focus of this project is on using a self-help intervention that provides advice, support, and motivation. However, studies suggest that depressed patients left alone with the devices fail to make good use of self-help interventions. Therefore, nurses will monitor participants by a web-based dashboard connected to the smartphone application (CONEMO), motivate to continue using CONEMO if participants are non-adherent and give technical support. Nurses will take part in supervision meetings at least once a week.
Method:
CONEMO is a randomized controlled trial conducted with 432 chronic patients who present diabetes and/or hypertension and depressive symptoms recruited in primary health care centers and public hospitals in Lima, Peru. Half of these participants will be randomized to receive the CONEMO intervention and the other half will receive enhanced usual care. The randomization will be made based on 2 strata: the health center/hospital the participant comes from and his/her PHQ9 score at screening (≤14; ≥15).
The intervention, based on behavior activation, is delivered by a smartphone and monitored by nurses who mediate this intervention, motivating and supporting the participant and monitoring his/her performance. The CONEMO intervention is delivered 3 times a week for a period of 6 weeks, summing up to a total of 18 sessions. Intensity of depressive symptoms is assessed by research assistants using the PHQ-9 at baseline, 3- and 6-month follow-up assessments.
Outcomes:
The primary outcome in this study is the proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 3-month assessment. The secondary outcomes are the proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month assessment, and the improvement in quality of life, adherence to diabetes, level of activity and hypertension medication and social functioning. There will also be a cost-effectiveness evaluation using a intention to treat analysis, and a process evaluation. For the process evaluation, data will be collected from questionnaires about the CONEMO system, filled out by with participants at 3 months after inclusion, and interviews with the nurses at the end of the intervention.
- Conditions
- Depression, Diabetes, Hypertension
- Being tested
- CONEMO
- Keywords
- Depression, Chronic diseases, Mobile technology, Clinical trial
- Medical subject headings
- Depression, Diabetes Mellitus, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONEMOBehavioural
Participants will be offered a behavioral activation-based intervention delivered by an application for smartphones (CONEMO) oriented to encourage them to be more active and to incorporate more activities in participants' everyday life.
Nurses will train participants to use CONEMO, make phone calls when participants are non-adherent, and provide technical support when necessary. Nurses will be supervised by clinical psychologists.
| Study group | Role | What they receive |
|---|---|---|
| CONEMO | Experimental | Participants in the intervention arm will receive a smartphone with CONEMO, an application with 18 sessions that are delivered 3 times a week for 6 weeks.
Additionally, all study participants, including those in the intervention arm, who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional. Receives: Behavioral: CONEMO |
| Control Group | No intervention | Participants in the control group will receive enhanced usual care. Participants who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a reduction of 50% or more in the Patient Health Questionnaire (PHQ-9) score at the 3-month assessment
Presence and severity of depressive symptoms is measured with the PHQ-9. A reduction of 50% or more in the PHQ-9 score at the 3-month assessment as compared to the PHQ-9 score at baseline will be considered as treatment success.
Measured: 3 months after inclusion
Secondary outcomes (6)
Proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month assessment
Presence and severity of depressive symptoms is measured with the PHQ-9. A reduction of 50% or more in the PHQ-9 score at the 6-month assessment as compared to the PHQ-9 score at baseline will be considered as treatment success.
Measured: 6 months after inclusion
Improvement in scores for Quality of Life measured by the EQD5 at the 3- and 6-month assessment
Quality of life will be measured at the 3- and 6-month assessments and compared to baseline using 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 inclusion
Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire at the 3- and 6-month assessments
Medication adherence to diabetes or hypertension will be measured using the Morisky Medication Adherence Scale (MMAS-4) at the 3- and 6-month assessments after inclusion and compared to baseline.
Measured: 3 and 6 months after inclusion
Proportion of participants who improve on social functioning at the 3- and 6-month assessments compared to the baseline.
Social functioning will be assessed with the WHO-DAS 2.0 12-item Interviewer-administered version in Spanish at the 3- and 6-month assessments after inclusion and compared to baseline. Its structure is unidimensional and has high internal consistency.
Measured: 3 and 6 months after inclusion
Cost-effectiveness: Number of medical consultations, hospitalizations, and visits to the health care team
Data on the use of health services will be collected at baseline, 3-month and 6-month assessments. Information about medical consultations, hospitalizations, and visits to the health care team will be obtained with a standardized questionnaire and cost-effectiveness analysis will be conducted.
Measured: 3 and 6 months after inclusion
Proportion of participants who improve level of activity at the 3- and 6-month assessments
Level of activity will be evaluated by the short form of the Behavioral Activation for Depression Scale (BADS) and assessed at baseline, 3-month, and 6-month follow-ups. 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 inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start24 Jan 2017
- Primary completion31 Mar 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital, National Institute of Mental Health (NIMH), Northwestern University
- Responsible party
- Principal investigator, Jaime Miranda, Universidad Peruana Cayetano Heredia
- Investigators
- Paulo R Menezes, MD, PhD, Principal investigator, University of Sao Paulo General HospitalRicardo B Araya, MD, PhD, Principal investigator, London School of Hygiene and Tropical MedicineJaime Miranda, MD, PhD, Principal investigator, Universidad Peruana Cayetano HerediaLisa Colpe, PhD, Principal investigator, National Institute of Mental Health (NIMH)Francisco Diez-Canseco, MSc, MPH, Study chair, Universidad Peruana Cayetano HerediaLena R Brandt, MSc, Study chair, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026426
- Sponsor's protocol ID
- 1U19MH098780-02 Peru
- Other IDs
- 1U19MH098780
- Acronym
- LATIN-MHPeru
- Status last verified
- May 2021
- First submitted
- 18 Jan 2017
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Menezess PR, Araya R, Miranda J, Mohr DC, Price le SN. The Latin American treatment and innovation network in mental health h (LATINMH): rationale and scope. Rev Fac Cien Med Univ Nac Cordoba. 2015;72(4):321-30.
PubMed 27107284Claro 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 38345934Toyama M, Cavero V, Araya R, Menezes PR, Mohr DC, Miranda JJ, Diez-Canseco F. Participants' and Nurses' Experiences With a Digital Intervention for Patients With Depressive Symptoms and Comorbid Hypertension or Diabetes in Peru: Qualitative Post-Randomized Controlled Trial Study. JMIR Hum Factors. 2022 Sep 15;9(3):e35486. doi: 10.2196/35486.
PubMed 36107482Vera 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 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effectiveness of a Mobile Technology Intervention in the Treatment of Depressive Symptoms in People With Diabetes or Hypertension in Peru
- ClinicalTrials.gov ID
- NCT03026426
- Acronym / sponsor ID
- LATIN-MHPeru / 1U19MH098780-02 Peru
- Conditions
- Depression, Diabetes, Hypertension
- Keywords
- Depression, Chronic diseases, Mobile technology, Clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital, National Institute of Mental Health (NIMH), Northwestern University
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 20 Jan 2017 (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 common comorbidity of physical chronic diseases such as diabetes and/or hypertension and constitutes an important public health problem. It correlates negatively with the patients' quality of life and self-care, as well as compliance with medical treatment. In low- and middle-income countries depression often goes unrecognized and untreated, and there are limited human resources to treat depression and other mental problems.
Aim: The present study aims to test a 6-week low-intensity psychological intervention (CONEMO - CONtrol EMOcional) delivered by a smartphone application to people with depressive symptoms and co-morbid diabetes and/or hypertension recruited in primary health care centers and public hospitals in Lima, Peru.
Detailed description
Epidemiologic research has clearly established the significant public health importance of mental disorders in low- and middle-income countries (LMIC). Among mental disorders, depression has become a major problem as a single condition and, more often, as part of complex clinical settings in which multiple conditions and risk factors are combined.
There is substantial co-morbidity between depression and chronic physical conditions, and the outcome of both conditions is impaired when there is this co-morbidity. Most of the disease burden in Latin America is attributable to chronic diseases such as cardio-vascular diseases as hypertension and diabetes, as well as to mental disorders such as depression. Despite the public health impact of depression, it often goes unrecognized and untreated. One important factor for this treatment gap are the limited financial and human resources. The mental health resources available in LMIC are often not optimally distributed either. Funds and trained personnel are typically allocated to 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 shortages, resource limitations, and budgetary inequities. The mental health field needs to consider developing self-help automated interventions that can reach people where there is insufficient access to specialized health care providers. This can be partially addressed applying two strategies: 1) increasing effective self-management; and 2) task-shifting roles to less specialized but appropriately trained health workers.
The investigators are conducting a randomized controlled trial with individuals with chronic diseases, i.e. hypertension and/or diabetes, and symptoms of depression in primary health centers and hospitals in Lima, Peru. Participants will be randomly assigned to the control arm or the intervention arm. The later will receive the CONEMO intervention, monitored by nurses.
The focus of this project is on using a self-help intervention that provides advice, support, and motivation. However, studies suggest that depressed patients left alone with the devices fail to make good use of self-help interventions. Therefore, nurses will monitor participants by a web-based dashboard connected to the smartphone application (CONEMO), motivate to continue using CONEMO if participants are non-adherent and give technical support. Nurses will take part in supervision meetings at least once a week.
Method:
CONEMO is a randomized controlled trial conducted with 432 chronic patients who present diabetes and/or hypertension and depressive symptoms recruited in primary health care centers and public hospitals in Lima, Peru. Half of these participants will be randomized to receive the CONEMO intervention and the other half will receive enhanced usual care. The randomization will be made based on 2 strata: the health center/hospital the participant comes from and his/her PHQ9 score at screening (≤14; ≥15).
The intervention, based on behavior activation, is delivered by a smartphone and monitored by nurses who mediate this intervention, motivating and supporting the participant and monitoring his/her performance. The CONEMO intervention is delivered 3 times a week for a period of 6 weeks, summing up to a total of 18 sessions. Intensity of depressive symptoms is assessed by research assistants using the PHQ-9 at baseline, 3- and 6-month follow-up assessments.
Outcomes:
The primary outcome in this study is the proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 3-month assessment. The secondary outcomes are the proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month assessment, and the improvement in quality of life, adherence to diabetes, level of activity and hypertension medication and social functioning. There will also be a cost-effectiveness evaluation using a intention to treat analysis, and a process evaluation. For the process evaluation, data will be collected from questionnaires about the CONEMO system, filled out by with participants at 3 months after inclusion, and interviews with the nurses at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONEMO | Experimental | Behavioral: CONEMOParticipants in the intervention arm will receive a smartphone with CONEMO, an application with 18 sessions that are delivered 3 times a week for 6 weeks. Additionally, all study participants, including those in the intervention arm, who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional. |
| Control Group | No intervention | –Participants in the control group will receive enhanced usual care. Participants who present a high risk of suicide and/or have a PHQ-9 score ≥20 are referred to the system for follow up. Participants with lower levels of depressive symptoms receive the recommendation of going to a mental health professional. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 or older
- Presenting depressive symptoms (PHQ9≥10)
- Clinical diagnosis of diabetes and/or hypertension
- Able to read
Key exclusion criteria (2 listed)
- If pregnant, the diagnosis of hypertension or diabetes is not related to the current pregnancy
- Moderate or severe suicide risk (Level B2 or C measured by S-RAP)
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 |
|---|---|---|
| CONEMOParticipants will be offered a behavioral activation-based intervention delivered by an application for smartphones (CONEMO) oriented to encourage them to be more active and to incorporate more activities in participants' everyday life. Nurses will train participants to use CONEMO, make phone calls when participants are non-adherent, and provide technical support when necessary. Nurses will be supervised by clinical psychologists. | Behavioural | CONEMO |
Primary outcome
Proportion of participants with a reduction of 50% or more in the Patient Health Questionnaire (PHQ-9) score at the 3-month assessment
Time frame: 3 months after inclusion
Presence and severity of depressive symptoms is measured with the PHQ-9. A reduction of 50% or more in the PHQ-9 score at the 3-month assessment as compared to the PHQ-9 score at baseline will be considered as treatment success.
6 secondary outcomes
Proportion of participants with a reduction of 50% or more in the PHQ-9 score at the 6-month assessment
Time frame: 6 months after inclusion
Improvement in scores for Quality of Life measured by the EQD5 at the 3- and 6-month assessment
Time frame: 3 and 6 months after inclusion
Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire at the 3- and 6-month assessments
Time frame: 3 and 6 months after inclusion
Proportion of participants who improve on social functioning at the 3- and 6-month assessments compared to the baseline.
Time frame: 3 and 6 months after inclusion
Cost-effectiveness: Number of medical consultations, hospitalizations, and visits to the health care team
Time frame: 3 and 6 months after inclusion
Proportion of participants who improve level of activity at the 3- and 6-month assessments
Time frame: 3 and 6 months after inclusion
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 May 2021.
- Background: PubMed 27107284Menezess PR, Araya R, Miranda J, Mohr DC, Price le SN. The Latin American treatment and innovation network in mental health h (LATINMH): rationale and scope. Rev Fac Cien Med Univ Nac Cordoba. 2015;72(4):321-30.
- 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 36107482Toyama M, Cavero V, Araya R, Menezes PR, Mohr DC, Miranda JJ, Diez-Canseco F. Participants' and Nurses' Experiences With a Digital Intervention for Patients With Depressive Symptoms and Comorbid Hypertension or Diabetes in Peru: Qualitative Post-Randomized Controlled Trial Study. JMIR Hum Factors. 2022 Sep 15;9(3):e35486. doi: 10.2196/35486.
- 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
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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.
Paulo R Menezes, MD, PhD principal investigator
University of Sao Paulo General Hospital
Ricardo B Araya, MD, PhD principal investigator
London School of Hygiene and Tropical Medicine
Jaime Miranda, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia
8 sites 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 Universidad Peruana Cayetano Heredia at 8 sites in Peru.
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 4 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Peru. 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?
Proportion of participants with a reduction of 50% or more in the Patient Health Questionnaire (PHQ-9) score at the 3-month assessment (time frame: 3 months after inclusion). 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 NCT03026426, which also lists 6 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 May 2021.