Clinical trial NCT02846662: Effectiveness of a Mobile Technology Intervention for the Treatment of Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Diabetes
Hypertension
Keywords: depression
mobile technology
community trial
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Universidad Peruana Cayetano Heredia
name: London School of Hygiene and Tropical Medicine
name: Northwestern University
First posted: 2016-07-27
Enrollment: 880
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of participants with 50% reduction in PHQ-9 score a 3-month assessment
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Number of participants with 50% reduction in PHQ-9 score a 6-month assessment
timeFrame: 6 months after enrollment
measure: Improvement in scores for Quality of Life, as measured by the EQD5
timeFrame: 3 and 6 months after enrollment
measure: Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire
timeFrame: 3 and 6 months after enrollment
measure: Number of medical consultations, hospitalizations, and visits to the primary care team
timeFrame: 3 and 6 months after enrollment
measure: Proportion of participants who improve level of activity, as evaluated by the short form of the Behavioral Activation for Depression Scale (BADS)
timeFrame: 3 and 6 months after enrollment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: London School of Medicine
name: Ricardo Araya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Mental Health (NIMH)
name: Lisa Colpe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.