NCT03026426

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for phase_3 depression

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

January 24, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2018

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

January 18, 2017

Last Update Submit

May 6, 2021

Conditions

DepressionDiabetesHypertension

Keywords

DepressionChronic diseasesMobile technologyClinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    6 months after inclusion

  • Improvement in scores for Quality of Life measured by the EQD5 at the 3- and 6-month assessment

    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

    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.

    3 and 6 months after inclusion

  • Cost-effectiveness: Number of medical consultations, hospitalizations, and visits to the health care team

    3 and 6 months after inclusion

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

CONEMOBEHAVIORAL

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.

CONEMO

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

PoliclĂ­nico Bellavista

Callao, 07011, Peru

Location

Policlínico Hermana María Donrose Sutmöller

Callao, 07051, Peru

Location

Hospital Nacional Dos de Mayo

Lima, 15003, Peru

Location

Policlínico Juan José Rodríguez Lazo

Lima, 15054, Peru

Location

Hospital Nacional Arzobispo Loayza

Lima, 15082, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, 15102, Peru

Location

CAP III Carabayllo

Lima, 15316, Peru

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Related Publications (6)

  • 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.

    PMID: 27107284BACKGROUND

  • 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.

    PMID: 38345934DERIVED

  • Toyama 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.

    PMID: 36107482DERIVED

  • Vera 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.

    PMID: 34643538DERIVED

  • Araya 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.

    PMID: 33974019DERIVED

  • Rocha 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.

    PMID: 33546709DERIVED

MeSH Terms

Conditions

DepressionDiabetes MellitusHypertensionChronic Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

  • Francisco Diez-Canseco, MSc, MPH

    Universidad Peruana Cayetano Heredia

    STUDY CHAIR

  • Lena R Brandt, MSc

    Universidad Peruana Cayetano Heredia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 20, 2017

Study Start

January 24, 2017

Primary Completion

March 31, 2018

Study Completion

December 19, 2018

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Locations

PE(8)