Effectiveness of a Mobile Technology Intervention for the Treatment of Depression

NCT02846662 | Completed Phase 3 DMC

• 2 other identifiers: 1U19MH098780-01 SP1U19MH098780-01
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Depression; Diabetes; Hypertension

Keywords

depression; mobile technology; community trial

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after enrollment

Secondary Outcomes (5)

• Number of participants with 50% reduction in PHQ-9 score a 6-month assessment

  6 months after enrollment

• Improvement in scores for Quality of Life, as measured by the EQD5

  3 and 6 months after enrollment

• Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire

  3 and 6 months after enrollment

• Number of medical consultations, hospitalizations, and visits to the primary care team

  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)

  3 and 6 months after enrollment

Study Arms (2)

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.

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.

Interventions

CONEMO BEHAVIORAL

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.

CONEMO

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Attending one of 20 selected primary care clinics
• Clinical diagnosis of diabetes and/or hypertension
• Presenting with depressive symptoms (PHQ-9 ≥10)

You may not qualify if:

• Moderate to high suicidal risk (assessed with a standardized protocol)
• Not able to read

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Universidad Peruana Cayetano Heredia: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Northwestern University: collaborator

Study Sites (1)

Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

Related Publications (4)

• 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: 38345934 DERIVED

• 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: 34643538 DERIVED

• 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: 33974019 DERIVED

• 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: 33546709 DERIVED

MeSH Terms

Conditions

Depression; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ricardo Araya, PhD

  London School of Medicine

  PRINCIPAL INVESTIGATOR

• Lisa Colpe, PhD

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: July 27, 2016
• Study Start: September 19, 2016
• Primary Completion: March 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)