Internet-based Intervention Culturally Adapted for Treatment of Depression in the Ecuadorian Population

NCT04237714 | Unknown

• 1 other identifier: 00016-UV-E-2019
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Internet-Based Interventions are increasingly relevant as an alternative for reducing the gap in treatment of metal disorders such as depression, especially in resource-limited regions. In this study the investigators will try to evaluate the effectiveness of an Internet-Based Intervention culturally adapted to the Ecuadorian population for treatment of depression.

Conditions

Depression

Keywords

Cultural adaptation; Internet-based intervention; Depression

Outcome Measures

Primary Outcomes (2)

• Change in depression symptoms. Beck Depression Inventory- II (BDI-II)

  It is a 21 item self-report that measure the presence of depressive symptoms in the past two weeks. Spanish version by Sanz et al., 2003.

  Baseline (week 0), 3, 6 and 12 months.

• Change in depression symptoms. Patient Health Questionnaire (PHQ-9)

  The questionnaire is composed of 9 items, it can be used as a screening test or as an evaluation instrument for depressive disorder. Spanish version by Diez-Quevedo et al., 2001.

  Baseline (week 0), 3, 6 and 12 months.

Secondary Outcomes (13)

• Generalized Anxiety Disorder Scale (GAD-7)

  Baseline (week 0), 3, 6 and 12 months.

• Positive and Negative Affect Schedule (PANAS)

  Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months.

• Overall Anxiety Severity and Impairment Scale (OASIS)

  post-module (weekly for 8 weeks)

• Overall Depression Severity and Impairment Scale ODSIS

  post-module (weekly for 8 weeks)

• Assessment of Quality of life (AQoL-6D)

  Baseline (week 0), 3, 6 and 12 months

Study Arms (3)

IBI-based automated support

EXPERIMENTAL

Internet-based intervention with automated support by the system. It consistes in phone text messages twice a week for users. The content of the messages focuses on motivating and reminding users to complete the activities proposed in the program and reviewing the treatment contents. Additionally an automatic email is send if participants have not access the program for a week. The program also provides continuous feedback to users through transversal tools.

Behavioral: Smiling is fun

IBI-plus human support

EXPERIMENTAL

In this condition, the participants receive automated support explained above and additionally human support for a maximum of 5 minutes that consist in a weekly phone call provided by a psychologist. The content of phone calls is related with resolve questions or doubts about the use and clinical content of the IBI and also motivating and reminding the importance to complete activities in the program.

Behavioral: Smiling is fun

Control group

NO INTERVENTION

Waiting list control group.

Interventions

Smiling is fun BEHAVIORAL

Smile is Fun is a self-applied program that combines elements of prevention and psychological treatment for emotional disorders. It is delivered via the Internet and it is based on CBT technics. The program consists of 8 therapeutic modules and includes 3 transversal tools (activity report, calendar, how am I?) to provide feedback and accompany patients during the intervention. The program requires 8 to 10 weeks to complete in its entirety. The intervention, initially developed in Spain, will be adapted to the Ecuadorian culture including elements of the local population, such as, dialect, personal stories, examples and activities. The Ecuadorian version will be evaluate by health professional and users of public health system of Ecuador.

IBI-based automated support; IBI-plus human support

Eligibility Criteria

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

You may qualify if:

• Ability to understand and read Spanish and access to Internet and having an email address
• Access to a computer or smart phone with internet at home
• Criteria for diagnosis of depression disorder according to the MINI interview and score between 5 to 9 (mild) 10 to 14 (moderate) and 15 to 19 (Moderate/severe) on PHQ-9

You may not qualify if:

• Scores 20-27 (severe depression) on PHQ-9
• Suicidal risk
• Severe psychiatric disorders (schizophrenia, substance dependence, bipolar disorder, psychotic illness)
• Receiving psychological treatment for depression at the time of recruitment

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Carlos Quiñonez Freire

Santo Domingo, 230108, Ecuador

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Rosa M Baños, PhD

  University of Valencia

  STUDY DIRECTOR

Central Study Contacts

Carlos E Quiñonez, MSc

CONTACT

+593 999277152; carequi@alumni.uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 23, 2020
• Study Start: October 10, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)