Effectiveness of a mHealth Intervention for the Treatment of Depression in People With Diabetes or Hypertension in Peru (LATIN-MHPeru)
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|ClinicalTrials.gov Identifier: NCT03026426|
Recruitment Status : Active, not recruiting
First Posted : January 20, 2017
Last Update Posted : February 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Diabetes Hypertension||Behavioral: CONEMO||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||January 24, 2017|
|Actual Primary Completion Date :||March 30, 2018|
|Estimated Study Completion Date :||August 31, 2019|
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026426
|Callao, Peru, 07011|
|Policlínico Hermana María Donrose Sutmöller|
|Callao, Peru, 07051|
|Hospital Nacional Dos de Mayo|
|Lima, Peru, 15003|
|Policlínico Juan José Rodríguez Lazo|
|Lima, Peru, 15054|
|Hospital Nacional Arzobispo Loayza|
|Lima, Peru, 15082|
|Hospital Nacional Cayetano Heredia|
|Lima, Peru, 15102|
|CAP III Carabayllo|
|Lima, Peru, 15316|
|Universidad Peruana Cayetano Heredia|
|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|