Clinical trial NCT04237714: Internet-based Intervention Culturally Adapted for Treatment of Depression in the Ecuadorian Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Cultural adaptation
Internet-based intervention
Depression
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depression symptoms. Beck Depression Inventory- II (BDI-II)
timeFrame: Baseline (week 0), 3, 6 and 12 months.
measure: Change in depression symptoms. Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline (week 0), 3, 6 and 12 months.
Secondary outcomes:
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline (week 0), 3, 6 and 12 months.
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months.
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: post-module (weekly for 8 weeks)
measure: Overall Depression Severity and Impairment Scale ODSIS
timeFrame: post-module (weekly for 8 weeks)
measure: Assessment of Quality of life (AQoL-6D)
timeFrame: Baseline (week 0), 3, 6 and 12 months
measure: Trimbos/iMTA Questionnaire on costs on Psychiatric Illnesses (TIC-P)
timeFrame: Baseline (week 0), 3, 6 and 12 months.
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 3 months
measure: Attitudes Towards Psychological Interventions (APOI)
timeFrame: Baseline (week 0)
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline (week 0)
measure: Semi-structured qualitative interview
timeFrame: post-treatment (8 weeks)
measure: Working Alliance Inventory for Online Intervention-Short Form (WAI-TECH- SF)
timeFrame: Baseline (week 0)
measure: System Usability Scale (SUS)
timeFrame: 3 months
measure: Semi-structured qualitative interview
timeFrame: 3 months
Other outcomes:
Locations:
city: Santo Domingo
country: Ecuador
facility: Carlos Quiñonez Freire
Study officials:
affiliation: University of Valencia
name: Rosa M Baños, PhD
role: STUDY_DIRECTOR
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