DepressionNCT04237714
Internet-based Intervention Culturally Adapted for Treatment of Depression in the Ecuadorian Population
A study testing Smiling is fun in people with Depression, run by University of Valencia at 1 site in Ecuador.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Smiling is fun
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteEcuador
- Study dates
- 10 Oct 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Carlos Quiñonez Freire
Santo Domingo, 230108
Carlos Quiñonez Freire, MSc, +593 999277152, carequi@alumni.uv.es
About this study
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
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Smiling is fun
- Keywords
- Cultural adaptation, Internet-based intervention, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smiling is funBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Smiling is fun |
| Control group | No intervention | Waiting list control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (week 0), 3, 6 and 12 months.
Secondary outcomes (13)
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.
Measured: Baseline (week 0), 3, 6 and 12 months.
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.
Measured: Baseline (week 0), post-module (weekly for 8 weeks), 3, 6 and 12 months.
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
Measured: post-module (weekly for 8 weeks)
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).
Measured: post-module (weekly for 8 weeks)
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.
Measured: Baseline (week 0), 3, 6 and 12 months
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.
Measured: Baseline (week 0), 3, 6 and 12 months.
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
Measured: 3 months
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.
Measured: Baseline (week 0)
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.
Measured: Baseline (week 0)
Semi-structured qualitative interview
An Ad-hoc instrument with open questions created to investigate the reasons for abandoning treatment.
Measured: post-treatment (8 weeks)
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.
Measured: Baseline (week 0)
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start10 Oct 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa M Baños, PhD, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237714
- Sponsor's protocol ID
- 00016-UV-E-2019
- Status last verified
- May 2021
- First submitted
- 15 Jan 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersson G, Carlbring P, Titov N, Lindefors N. Internet Interventions for Adults with Anxiety and Mood Disorders: A Narrative Umbrella Review of Recent Meta-Analyses. Can J Psychiatry. 2019 Jul;64(7):465-470. doi: 10.1177/0706743719839381. Epub 2019 May 16.
PubMed 31096757Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151.
PubMed 25273302Berger T, Hammerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40(4):251-66. doi: 10.1080/16506073.2011.616531.
PubMed 22060248Cuijpers P, van Straten A, Andersson G, van Oppen P. Psychotherapy for depression in adults: a meta-analysis of comparative outcome studies. J Consult Clin Psychol. 2008 Dec;76(6):909-22. doi: 10.1037/a0013075.
PubMed 19045960Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119Espinosa HD, Carrasco A, Moessner M, Caceres C, Gloger S, Rojas G, Perez JC, Vanegas J, Bauer S, Krause M. Acceptability Study of "Ascenso": An Online Program for Monitoring and Supporting Patients with Depression in Chile. Telemed J E Health. 2016 Jul;22(7):577-83. doi: 10.1089/tmj.2015.0124. Epub 2016 Jan 7.
PubMed 26741190Hadjistavropoulos HD, Nugent MM, Alberts NM, Staples L, Dear BF, Titov N. Transdiagnostic Internet-delivered cognitive behaviour therapy in Canada: An open trial comparing results of a specialized online clinic and nonspecialized community clinics. J Anxiety Disord. 2016 Aug;42:19-29. doi: 10.1016/j.janxdis.2016.05.006. Epub 2016 May 13.
PubMed 27244278Harper Shehadeh M, Heim E, Chowdhary N, Maercker A, Albanese E. Cultural Adaptation of Minimally Guided Interventions for Common Mental Disorders: A Systematic Review and Meta-Analysis. JMIR Ment Health. 2016 Sep 26;3(3):e44. doi: 10.2196/mental.5776.
PubMed 27670598Bouwmans 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.
PubMed 23768141Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Qual Life Res. 1999 May;8(3):209-24. doi: 10.1023/a:1008815005736.
PubMed 10472152Helms JE. An examination of the evidence in culturally adapted evidence-based or empirically supported interventions. Transcult Psychiatry. 2015 Apr;52(2):174-97. doi: 10.1177/1363461514563642. Epub 2014 Dec 22.
PubMed 25534401Kroenke 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. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Lara MA, Tiburcio M, Aguilar Abrego A, Sanchez-Solis 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.
PubMed 25211568Mira A, Breton-Lopez J, Garcia-Palacios A, Quero S, Banos 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.
PubMed 28408833Munoz-Navarro R, Cano-Vindel A, Moriana JA, Medrano LA, Ruiz-Rodriguez P, Aguero-Gento L, Rodriguez-Enriquez M, Piza MR, Ramirez-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.
PubMed 28666201
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04237714
- Acronym / sponsor ID
- 00016-UV-E-2019
- Conditions
- Depression
- Keywords
- Cultural adaptation, Internet-based intervention, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI-based automated support | Experimental | Behavioral: Smiling is funInternet-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. |
| IBI-plus human support | Experimental | Behavioral: Smiling is funIn 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. |
| Control group | No intervention | –Waiting list control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smiling is funSmile 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. | Behavioural | IBI-based automated support, IBI-plus human support |
Primary outcome
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.
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.
13 secondary outcomes
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 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.
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: post-module (weekly for 8 weeks)
Overall Depression Severity and Impairment Scale ODSIS
Time frame: post-module (weekly for 8 weeks)
Assessment of Quality of life (AQoL-6D)
Time frame: 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.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 3 months
Attitudes Towards Psychological Interventions (APOI)
Time frame: Baseline (week 0)
Credibility and Expectancy Questionnaire (CEQ)
Time frame: Baseline (week 0)
Semi-structured qualitative interview
Time frame: post-treatment (8 weeks)
Working Alliance Inventory for Online Intervention-Short Form (WAI-TECH- SF)
Time frame: Baseline (week 0)
System Usability Scale (SUS)
Time frame: 3 months
Semi-structured qualitative interview
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 31096757Andersson G, Carlbring P, Titov N, Lindefors N. Internet Interventions for Adults with Anxiety and Mood Disorders: A Narrative Umbrella Review of Recent Meta-Analyses. Can J Psychiatry. 2019 Jul;64(7):465-470. doi: 10.1177/0706743719839381. Epub 2019 May 16.
- Background: PubMed 25273302Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151.
- Background: PubMed 22060248Berger T, Hammerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40(4):251-66. doi: 10.1080/16506073.2011.616531.
- Background: PubMed 19045960Cuijpers P, van Straten A, Andersson G, van Oppen P. Psychotherapy for depression in adults: a meta-analysis of comparative outcome studies. J Consult Clin Psychol. 2008 Dec;76(6):909-22. doi: 10.1037/a0013075.
- Background: PubMed 11132119Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- Background: PubMed 26741190Espinosa HD, Carrasco A, Moessner M, Caceres C, Gloger S, Rojas G, Perez JC, Vanegas J, Bauer S, Krause M. Acceptability Study of "Ascenso": An Online Program for Monitoring and Supporting Patients with Depression in Chile. Telemed J E Health. 2016 Jul;22(7):577-83. doi: 10.1089/tmj.2015.0124. Epub 2016 Jan 7.
- Background: PubMed 27244278Hadjistavropoulos HD, Nugent MM, Alberts NM, Staples L, Dear BF, Titov N. Transdiagnostic Internet-delivered cognitive behaviour therapy in Canada: An open trial comparing results of a specialized online clinic and nonspecialized community clinics. J Anxiety Disord. 2016 Aug;42:19-29. doi: 10.1016/j.janxdis.2016.05.006. Epub 2016 May 13.
- Background: PubMed 27670598Harper Shehadeh M, Heim E, Chowdhary N, Maercker A, Albanese E. Cultural Adaptation of Minimally Guided Interventions for Common Mental Disorders: A Systematic Review and Meta-Analysis. JMIR Ment Health. 2016 Sep 26;3(3):e44. doi: 10.2196/mental.5776.
- Background: PubMed 23768141Bouwmans 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.
- Background: PubMed 10472152Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Qual Life Res. 1999 May;8(3):209-24. doi: 10.1023/a:1008815005736.
- Background: PubMed 25534401Helms JE. An examination of the evidence in culturally adapted evidence-based or empirically supported interventions. Transcult Psychiatry. 2015 Apr;52(2):174-97. doi: 10.1177/1363461514563642. Epub 2014 Dec 22.
- Background: PubMed 11556941Kroenke 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. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M Baños, PhD study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smiling is fun in people with Depression, run by University of Valencia at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos E Quiñonez, MSc (+593 999277152, carequi@alumni.uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptoms. Beck Depression Inventory- II (BDI-II) (time frame: Baseline (week 0), 3, 6 and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237714, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.