Internet-based Intervention Culturally Adapted for Treatment of Depression in the Ecuadorian Population
NCT ID: NCT04237714
Last Updated: 2021-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
153 participants
INTERVENTIONAL
2020-10-10
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Control group
Waiting list control group.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Suicidal risk
* Severe psychiatric disorders (schizophrenia, substance dependence, bipolar disorder, psychotic illness)
* Receiving psychological treatment for depression at the time of recruitment
18 Years
65 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Principal Investigators
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Rosa M Baños, PhD
Role: STUDY_DIRECTOR
University of Valencia
Locations
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Carlos Quiñonez Freire
Santo Domingo, , Ecuador
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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00016-UV-E-2019
Identifier Type: -
Identifier Source: org_study_id
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