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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237714
• Other study ID #: 00016-UV-E-2019
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: University of Valencia
• Contact: Carlos E Quiñonez, MSc
• Phone: +593 999277152
• Email: carequi[@]alumni.uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Ecuador	Carlos Quiñonez Freire	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Ecuador, 

References & Publications (26)

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Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, Hakkaart-van Roijen L. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013 Jun 15;13:217. doi: 10.1186/1472-6963-13-217. — View Citation

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Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Lara MA, Tiburcio M, Aguilar Abrego A, Sánchez-Solís A. A four-year experience with a Web-based self-help intervention for depressive symptoms in Mexico. Rev Panam Salud Publica. 2014 May-Jun;35(5-6):399-406. — View Citation

mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP): Version 2.0. Geneva: World Health Organization; 2016. — View Citation

Mira A, Bretón-López J, García-Palacios A, Quero S, Baños RM, Botella C. An Internet-based program for depressive symptoms using human and automated support: a randomized controlled trial. Neuropsychiatr Dis Treat. 2017 Mar 31;13:987-1006. doi: 10.2147/NDT.S130994. eCollection 2017. — View Citation

Muñoz-Navarro R, Cano-Vindel A, Moriana JA, Medrano LA, Ruiz-Rodríguez P, Agüero-Gento L, Rodríguez-Enríquez M, Pizà MR, Ramírez-Manent JI. Screening for generalized anxiety disorder in Spanish primary care centers with the GAD-7. Psychiatry Res. 2017 Oct;256:312-317. doi: 10.1016/j.psychres.2017.06.023. Epub 2017 Jun 12. — View Citation

Osma J, Quilez-Orden A, Suso-Ribera C, Peris-Baquero O, Norman SB, Bentley KH, Sauer-Zavala S. Psychometric properties and validation of the Spanish versions of the overall anxiety and depression severity and impairment scales. J Affect Disord. 2019 Jun 1;252:9-18. doi: 10.1016/j.jad.2019.03.063. Epub 2019 Mar 29. — View Citation

Parada F, Martínez V, Espinosa HD, Bauer S, Moessner M. Using Persuasive Systems Design Model to Evaluate "Cuida tu Ánimo": An Internet-Based Pilot Program for Prevention and Early Intervention of Adolescent Depression. Telemed J E Health. 2020 Feb;26(2):251-254. doi: 10.1089/tmj.2018.0272. Epub 2019 Jan 21. — View Citation

Richards D, Timulak L, O'Brien E, Hayes C, Vigano N, Sharry J, Doherty G. A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Behav Res Ther. 2015 Dec;75:20-31. doi: 10.1016/j.brat.2015.10.005. Epub 2015 Oct 21. — View Citation

Salamanca-Sanabria A, Richards D, Timulak L, Castro-Camacho L, Mojica-Perilla M, Parra-Villa Y. Assessing the efficacy of a culturally adapted cognitive behavioural internet-delivered treatment for depression: protocol for a randomised controlled trial. BMC Psychiatry. 2018 Feb 27;18(1):53. doi: 10.1186/s12888-018-1634-x. — View Citation

Schröder J, Sautier L, Kriston L, Berger T, Meyer B, Späth C, Köther U, Nestoriuc Y, Klein JP, Moritz S. Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. J Affect Disord. 2015 Nov 15;187:136-41. doi: 10.1016/j.jad.2015.08.044. Epub 2015 Aug 28. — View Citation

Tiburcio M, Lara MA, Aguilar Abrego A, Fernández M, Martínez Vélez N, Sánchez A. Web-Based Intervention to Reduce Substance Abuse and Depressive Symptoms in Mexico: Development and Usability Test. JMIR Ment Health. 2016 Sep 29;3(3):e47. doi: 10.2196/mental.6001. — View Citation

Tiburcio M, Lara MA, Martínez N, Fernández M, Aguilar A. Web-Based Intervention to Reduce Substance Abuse and Depression: A Three Arm Randomized Trial in Mexico. Subst Use Misuse. 2018 Nov 10;53(13):2220-2231. doi: 10.1080/10826084.2018.1467452. Epub 2018 May 16. — View Citation

van Ballegooijen W, Cuijpers P, van Straten A, Karyotaki E, Andersson G, Smit JH, Riper H. Adherence to Internet-based and face-to-face cognitive behavioural therapy for depression: a meta-analysis. PLoS One. 2014 Jul 16;9(7):e100674. doi: 10.1371/journal.pone.0100674. eCollection 2014. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Generalized Anxiety Disorder Scale (GAD-7)	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.
Secondary	Positive and Negative Affect Schedule (PANAS)	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.
Secondary	Overall Anxiety Severity and Impairment Scale (OASIS)	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)
Secondary	Overall Depression Severity and Impairment Scale ODSIS	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)
Secondary	Assessment of Quality of life (AQoL-6D)	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
Secondary	Trimbos/iMTA Questionnaire on costs on Psychiatric Illnesses (TIC-P)	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.
Secondary	Client Satisfaction Questionnaire (CSQ-8)	This is a 8-item questionnaire that measures the perception of the attention received. Spanish version by Echeburúa & Corral, 1998	3 months
Secondary	Attitudes Towards Psychological Interventions (APOI)	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)
Secondary	Credibility and Expectancy Questionnaire (CEQ)	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)
Secondary	Semi-structured qualitative interview	An Ad-hoc instrument with open questions created to investigate the reasons for abandoning treatment.	post-treatment (8 weeks)
Secondary	Working Alliance Inventory for Online Intervention-Short Form (WAI-TECH- SF)	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)
Secondary	System Usability Scale (SUS)	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
Secondary	Semi-structured qualitative interview	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