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Trial record 17 of 1403 for:    Peru

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026426
Recruitment Status : Active, not recruiting
First Posted : January 20, 2017
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
University of Sao Paulo General Hospital
National Institute of Mental Health (NIMH)
Northwestern University
Information provided by (Responsible Party):
Jaime Miranda, Universidad Peruana Cayetano Heredia

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.


Condition or disease Intervention/treatment Phase
Depression Diabetes Hypertension Behavioral: CONEMO Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
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Peru
Policlínico Bellavista
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
Lima, Peru
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
University of Sao Paulo General Hospital
National Institute of Mental Health (NIMH)
Northwestern University
Investigators
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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:
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Responsible Party: Jaime Miranda, Dr., Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT03026426     History of Changes
Other Study ID Numbers: 1U19MH098780-02PERU ( U.S. NIH Grant/Contract )
1U19MH098780 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaime Miranda, Universidad Peruana Cayetano Heredia:
Depression
Chronic diseases
Mobile technology
Clinical trial
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders