Effectiveness of a mHealth Intervention for the Treatment of Depression in People With Diabetes or Hypertension in Peru (LATIN-MHPeru)

May 6, 2021 updated by: Jaime Miranda, Universidad Peruana Cayetano Heredia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
432

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Callao, Peru, 07011
        • Policlínico Bellavista
      • Callao, Peru, 07051
        • Policlínico Hermana María Donrose Sutmöller
      • Lima, Peru, 15003
        • Hospital Nacional Dos de Mayo
      • Lima, Peru, 15054
        • Policlínico Juan José Rodríguez Lazo
      • Lima, Peru, 15082
        • Hospital Nacional Arzobispo Loayza
      • Lima, Peru, 15102
        • Hospital Nacional Cayetano Heredia
      • Lima, Peru, 15316
        • CAP III Carabayllo
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 21 or older
  • Presenting depressive symptoms (PHQ9≥10)
  • Clinical diagnosis of diabetes and/or hypertension
  • Able to read

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CONEMO

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.
Behavioral: CONEMO

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.
No Intervention: Control Group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
3 and 6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Peruana Cayetano Heredia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Northwestern University
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paulo R Menezes, MD, PhD, University of Sao Paulo General Hospital
  • Principal Investigator: Ricardo B Araya, MD, PhD, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Jaime Miranda, MD, PhD, Universidad Peruana Cayetano Heredia
  • Principal Investigator: Lisa Colpe, PhD, National Institute of Mental Health (NIMH)
  • Study Chair: Francisco Diez-Canseco, MSc, MPH, Universidad Peruana Cayetano Heredia
  • Study Chair: Lena R Brandt, MSc, Universidad Peruana Cayetano Heredia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1U19MH098780-02PERU (U.S. NIH Grant/Contract)
  • 1U19MH098780 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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