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

June 1, 2021 updated by: University of Valencia

Cultural Adaptation of the Smile is Fun Program for the Treatment of Depression in the Ecuadorian Public Health Care System: A Study Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Our participants will be randomized to one of the following three conditions: 1) Internet-Based intervention (IBI) with automated support (e.g. e-mails or text messages), 2) IBI plus human support by phone calls (automated + human support), 3) Waiting list control group .

The corresponding evaluations of the outcomes will be carried out at different moments of the process: baseline, three, six and twelve months.

This study will use the Smile is Fun program for the treatment of depression previously adapted to the Ecuadorian context.

Study Type

Interventional

Enrollment (Anticipated)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ecuador
      • Santo Domingo, Ecuador, 230108
        • Recruiting
        • Carlos Quiñonez Freire
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI-based automated support
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

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.
Experimental: IBI-plus human support
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

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.
No Intervention: Control group
Waiting list control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression symptoms. Beck Depression Inventory- II (BDI-II)
Time Frame: Baseline (week 0), 3, 6 and 12 months.
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)
Time Frame: Baseline (week 0), 3, 6 and 12 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: Baseline (week 0), 3, 6 and 12 months.
It is a 7-item scale designed for symptom detection and severity analysis of generalized anxiety disorder. Spanish version by Muñoz-Navarro et al., 2017.
Baseline (week 0), 3, 6 and 12 months.
Positive and Negative Affect Schedule (PANAS)
Time Frame: Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months.
This scale consists of 2 subscales, each with 10 items that value positive and negative affects. Spanish version by Lopez-Gomez, Hervas, & Vazquez, 2015.
Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months.
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: post-module (weekly for 8 weeks)
This scale has five items related with: the frequency of symptoms of anxiety, their intensity, their interference with the person's work or school life, and their interference with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety). Spanish version by Osma, J et al. 2019
post-module (weekly for 8 weeks)
Overall Depression Severity and Impairment Scale ODSIS
Time Frame: post-module (weekly for 8 weeks)
The ODSIS includes five items related with: the frequency of symptoms of depression, their intensity, their interference with the person's work or school life, and their interference with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel depression) to 4 (Constant depression).
post-module (weekly for 8 weeks)
Assessment of Quality of life (AQoL-6D)
Time Frame: Baseline (week 0), 3, 6 and 12 months
It is a 20-item questionnaire that measures the following dimensions of the patient's health status: illness, independence to live, social relationships, physical and psychological well-being.
Baseline (week 0), 3, 6 and 12 months
Trimbos/iMTA Questionnaire on costs on Psychiatric Illnesses (TIC-P)
Time Frame: Baseline (week 0), 3, 6 and 12 months.
Questionnaire used to collect information on health services and medication received during the last months, as well as, information on productivity loss in paid and unpaid work depending on the illness.
Baseline (week 0), 3, 6 and 12 months.
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 3 months
This is a 8-item questionnaire that measures the perception of the attention received. Spanish version by Echeburúa & Corral, 1998
3 months
Attitudes Towards Psychological Interventions (APOI)
Time Frame: Baseline (week 0)
The questionnaire measures expectations towards online psychological interventions. Its 16 items measure: a) skepticism and risk perception, b) confidence in effectiveness, c) risks of technology and d) anonymous benefits.
Baseline (week 0)
Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Baseline (week 0)
This scale is a self-administered 6-item assessment instrument created to measure the belief that the treatment works and the expectations that the treatment will improve.
Baseline (week 0)
Semi-structured qualitative interview
Time Frame: post-treatment (8 weeks)
An Ad-hoc instrument with open questions created to investigate the reasons for abandoning treatment.
post-treatment (8 weeks)
Working Alliance Inventory for Online Intervention-Short Form (WAI-TECH- SF)
Time Frame: Baseline (week 0)
It is a 12-item self-report adapted of the WAI-SF (Hatcher and Gillaspy, 2006). This questionnaire aimed at assessing the working alliance with the online intervention.
Baseline (week 0)
System Usability Scale (SUS)
Time Frame: 3 months
The SUS is a 10-item self-report scale from 0 ("strongly disagree") to 4 ("strongly agree") that measures the usability of a service or product and the acceptance of technology by people who use it.
3 months
Semi-structured qualitative interview
Time Frame: 3 months
A 11-item qualitative interview will be developed. It consists of 6 items rated on a scale from 1 ("very little") to 5 ("very much") and 4 dichotomous questions ("yes" or "no") to assess participants' opinions about the program and the support received.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Study Director: Rosa M Baños, PhD, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00016-UV-E-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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