Depressive DisorderNCT05294614
Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care
A study testing "Sonreír es diveritdo" - Smiling is fun in people with Depressive Disorder and Depressive Symptoms, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Implementation of a psychological online intervention for low to moderate depression in primary care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Depressive Symptoms, Depression
- What is being tested?
- "Sonreír es diveritdo" - Smiling is fun
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2022to Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Over 18 years old.
- DSM-5 Diagnosis of Major Depression.
- Severity of mild or moderate depression (score less than 14 points on PHQ-9).
- Duration of depressive symptoms 2 months or more.
- Availability of computer with Internet connection.
- Understand Spanish spoken and written.
- Give informed consent.
Who cannot join
- Disease affecting the Central Nervous System.
- Other psychiatric diagnosis or illness severe psychiatric (substance dependence and abuse, psychosis, eating disorders, etc.) a exception of anxiety pathology or personality disorders.
- Presence of medical illness, uncontrolled severe degenerative or infectious disease.
- Presence of delusions or hallucinations in the time of study.
- Risk of suicide.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Rosa Lorente Català
Castellon, Castellón, 12071
Rosa Lorente Català, Psychology, 0034691527941, rlorente@uji.es
Azucena García Palacios, Psychology, azucena@uji.es
About this study
Official title: Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care: a Study Protocol
Implementation of a psychological online intervention for low to moderate depression in primary care settings.
Read the detailed description
Depression is highly prevalent in primary care. Meta-analysis show that pharmacotherapy and psychotherapy are effective. Given the high cost of face-to-face psychotherapy, alternative procedures of psychotherapy delivery have been proposed, emphasizing the use of technologies like the Internet. Several studies demostrated the effectiveness of Internet-based psychological interventions in primary care. Once established the efficacy and cost-effectiveness, the next step is the implementation of such programs in routine clinical practise. Literature indicates that there is a gap between the validation of evidence-based interventions and their use in routine practice of around 20 years. The science of implementation has developed procedures to reduce such gap. The objective of this study is to carry out an implementation study with a hybrid design to determine the impact of the intervention (Smiling is Fun) in terms of health outcomes and feasibility of the implementation. Participants will adopt the framework proposed by Hermes et al., inspired in Proctor's recommendations. The study will be conducted in Andalucia, Aragon and Baleares. It is hypothesized that it will be feasible to implement a psychological intervention supported by ICTs in the context of primary care for the treatment of mild-moderate depression. Furthermore, specific hypothesis are established; 1) the intervention will be effective after six months of completion of treatment (efficacy measure: PHQ9), 2) the psychological intervention applied through ICTs in primary care will be cost-effective, 3) the acceptability of the intervention will be high by the agents involved: patients, professionals and administrators (results of interviews and focus groups), this acceptability will also be high with regarding the usability of the designed computer system (measured by the System Usability Scale), 4) the data about the use of the platform by patients and professionals will demonstrate that the intervention is adopted, feasible, and high fidelity (modules and tasks completed) and 5) the adequacy of the ICT-supported intervention perceived by professionals, patients andadministrators will be elevated (NoMAD questionnaire and results of interviews and focus groups).The final goal of this study is to demonstrate the feasibility of using the online intervention in order to guarantee that the investment in efficacy research lead to a better care in routine clinical practice and an improvement in public health.
- Conditions
- Depressive Disorder, Depressive Symptoms, Depression
- Being tested
- "Sonreír es diveritdo" - Smiling is fun
- Keywords
- Depressive disorder, Depression, Implementation, Evidence-based intervention, Online intervention, Psychological intervention, Primary care, Health care settings
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Sonreír es diveritdo" - Smiling is funBehavioural
Smiling is Fun is an online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules. The modules and their aims are: 1) Motivation for change; advantages and disadvantages of changing and importance of motivation; 2) Understanding emotional problems; psychoeducational information, maintaining factors and management of medication and sleep hygiene; 3) Learning to get going; behavioural activation strategies; 4) Learning to be flexible; how interpret negative thoughts and situations in a more flexible way; 5) Learning to enjoy; importance of positive emotions and strategies to promote them; 6) Learning to live; how to identify the psychological strengths and importance of doing activities based on values and vital goals; 7) Living and learning; putting into practice the strengths identified in previous module; 8) From now on… what?; a relapse prevention module.
| Study group | Role | What they receive |
|---|---|---|
| A B B B B B B B B C C C C C C | Other | Considering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A B B B B B B B B C C C C C C.
In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. Receives: Behavioral: "Sonreír es diveritdo" - Smiling is fun |
| A A B B B B B B B B C C C C C | Other | Considering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A A B B B B B B B B C C C C C.
In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. Receives: Behavioral: "Sonreír es diveritdo" - Smiling is fun |
| A A A B B B B B B B B C C C C | Other | Considering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A A A B B B B B B B B C C C C.
In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. Receives: Behavioral: "Sonreír es diveritdo" - Smiling is fun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the intervention
Change of depression symtpmatology through the Patient Health Questionnaire-9 (PHQ-9) after the intervention.
Measured: Pre-intervention and immediately after the intervention
Secondary outcomes (6)
Acceptability
Assesment of the usability, defined as the facility of use percibed by the users through the System Usability Scale.
Measured: Pre-intervention and immediately after the intervention
Acceptability
Satisfaction of the online intervention through the Client Satisfaction Questionnaire (CSQ-1).
Measured: Immediately after the intervention
Adaptation
Assesment of the process of normalization of an intervention through the Normalization MeAsure Development Questionnaire (NoMAD).
Measured: Pre-intervention, immediately after the intervention and follow-up
Adoption, viability and fidelity
Assessed with the infromation proportioned by the online intervention. Specifically: number of access to the application, number of completed modules and number of performed tasks
Measured: Pre-intervention and immediately after the intervention
Implementation costs
Assessment of the use of health and social services and other economical impacts thourgh the Client Service Receipt Inventory (CSRI).
Measured: Pre-intervention and immediately after the intervention AND follow-up
Diagnostic Interview
Assessment of the diagnostic criteria included in the DSM-V.
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start30 Mar 2022
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- The general framework determined for the study design is that indicated by Hermes. A hybrid type II design, where effectiveness and implementation will be evaluated is selected. Regarding the specific design of the empirical study, a stepped wedge (SW) design will be used, which represent a variation of the clinical trials randomized by clusters. All groups receive the treatment but its initiation is done in a randomized order and the treatment is introduced to different groups in a staggered and sequential way. The duration of each phase (e.g. control and treatment), it is determined randomly for each group. The study should be considered a closed cohort, since the same participants will be evaluated over time through a series of time points defined a priori and the inclusion of new participants will not be allowed once the trial has started. sequences will be randomly assigned.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332
- Responsible party
- Sponsor
- Investigators
- Azucena García Palacios, Principal investigator, University Jaume IJavier García Campayo, Principal investigator, Institute of Health Research of AragonMargalida Gili, Principal investigator, Research Institute of Health Sciences, University of Balearic Islands, Palma de MallorcaFermín Mayoral Cleries, Principal investigator, University Regional Hospital of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294614
- Sponsor's protocol ID
- P19/00723
- Status last verified
- Jun 2022
- First submitted
- 14 Dec 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mira A, Soler C, Alda M, Banos R, Castilla D, Castro A, Garcia-Campayo J, Garcia-Palacios A, Gili M, Hurtado M, Mayoral F, Montero-Marin J, Botella C. Exploring the Relationship Between the Acceptability of an Internet-Based Intervention for Depression in Primary Care and Clinical Outcomes: Secondary Analysis of a Randomized Controlled Trial. Front Psychiatry. 2019 May 10;10:325. doi: 10.3389/fpsyt.2019.00325. eCollection 2019.
PubMed 31133899Romero-Sanchiz P, Nogueira-Arjona R, Garcia-Ruiz A, Luciano JV, Garcia Campayo J, Gili M, Botella C, Banos R, Castro A, Lopez-Del-Hoyo Y, Perez Ara MA, Modrego-Alarcon M, Mayoral Cleries F. Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multi-center, three-armed randomized controlled trial conducted in primary care. PLoS One. 2017 Feb 27;12(2):e0172741. doi: 10.1371/journal.pone.0172741. eCollection 2017.
PubMed 28241025Montero-Marin J, Araya R, Perez-Yus MC, Mayoral F, Gili M, Botella C, Banos R, Castro A, Romero-Sanchiz P, Lopez-Del-Hoyo Y, Nogueira-Arjona R, Vives M, Riera A, Garcia-Campayo J. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial. J Med Internet Res. 2016 Aug 26;18(8):e231. doi: 10.2196/jmir.5695.
PubMed 27565118Montero-Marin J, Prado-Abril J, Botella C, Mayoral-Cleries F, Banos R, Herrera-Mercadal P, Romero-Sanchiz P, Gili M, Castro A, Nogueira R, Garcia-Campayo J. Expectations among patients and health professionals regarding Web-based interventions for depression in primary care: a qualitative study. J Med Internet Res. 2015 Mar 10;17(3):e67. doi: 10.2196/jmir.3985.
PubMed 25757358Karyotaki E, Kemmeren L, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJH, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Is self-guided internet-based cognitive behavioural therapy (iCBT) harmful? An individual participant data meta-analysis. Psychol Med. 2018 Nov;48(15):2456-2466. doi: 10.1017/S0033291718000648. Epub 2018 Mar 15.
PubMed 29540243Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. JAMA Psychiatry. 2017 Apr 1;74(4):351-359. doi: 10.1001/jamapsychiatry.2017.0044.
PubMed 28241179Mira 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 28408833Karyotaki E, Kleiboer A, Smit F, Turner DT, Pastor AM, Andersson G, Berger T, Botella C, Breton JM, Carlbring P, Christensen H, de Graaf E, Griffiths K, Donker T, Farrer L, Huibers MJ, Lenndin J, Mackinnon A, Meyer B, Moritz S, Riper H, Spek V, Vernmark K, Cuijpers P. Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis. Psychol Med. 2015 Oct;45(13):2717-26. doi: 10.1017/S0033291715000665. Epub 2015 Apr 17.
PubMed 25881626GBD 2015 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1603-1658. doi: 10.1016/S0140-6736(16)31460-X.
PubMed 27733283Pakenham-Walsh, Neil. (2004). Learning from one another to bridge the "know-do gap". BMJ. 329. 10.1136/bmj.329.7475.1189.
Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
PubMed 22179294Lorente-Catala R, Castro A, Fernandez-Martinez S, Varela-Moreno E, Guerrero-Pertinez G, Forteza-Rey I, Gili M, Lopez-Del-Hoyo Y, Mayoral-Cleries F, Garcia-Campayo J, Garcia-Palacios A. Implementation of an Internet-based psychological intervention for the treatment of mild depression in primary care: a hybrid effectiveness-implementation approach. BMC Public Health. 2026 Jun 3. doi: 10.1186/s12889-026-27573-0. Online ahead of print.
PubMed 42237276Lorente-Catala R, Garcia-Palacios A. Hybrid effectiveness-implementation studies in mental health: three practical examples. JBI Evid Implement. 2026 Jul 1;24(3):652-668. doi: 10.1097/XEB.0000000000000592.
PubMed 42112661Lorente-Catala R, Gili M, Lopez-Del-Hoyo Y, Mayoral-Cleries F, Perez-Aranda A, Castro A, Varela-Moreno E, Banos RM, Roca M, Monreal-Bartolome A, Garcia-Palacios A. Implementation of a psychological online intervention for low to moderate depression in primary care: study protocol. Internet Interv. 2022 Nov 1;30:100581. doi: 10.1016/j.invent.2022.100581. eCollection 2022 Dec.
PubMed 36573071
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Psychological Online Intervention for Low to Moderate Depression in Primary Health Care: a Study Protocol
- ClinicalTrials.gov ID
- NCT05294614
- Acronym / sponsor ID
- P19/00723
- Conditions
- Depressive Disorder, Depressive Symptoms, Depression
- Keywords
- Depressive disorder, Depression, Implementation, Evidence-based intervention, Online intervention, Psychological intervention, Primary care, Health care settings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital. ACIF/2020/332
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 24 Mar 2022 (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.
Implementation of a psychological online intervention for low to moderate depression in primary care settings.
Detailed description
Depression is highly prevalent in primary care. Meta-analysis show that pharmacotherapy and psychotherapy are effective. Given the high cost of face-to-face psychotherapy, alternative procedures of psychotherapy delivery have been proposed, emphasizing the use of technologies like the Internet. Several studies demostrated the effectiveness of Internet-based psychological interventions in primary care. Once established the efficacy and cost-effectiveness, the next step is the implementation of such programs in routine clinical practise. Literature indicates that there is a gap between the validation of evidence-based interventions and their use in routine practice of around 20 years. The science of implementation has developed procedures to reduce such gap. The objective of this study is to carry out an implementation study with a hybrid design to determine the impact of the intervention (Smiling is Fun) in terms of health outcomes and feasibility of the implementation. Participants will adopt the framework proposed by Hermes et al., inspired in Proctor's recommendations. The study will be conducted in Andalucia, Aragon and Baleares. It is hypothesized that it will be feasible to implement a psychological intervention supported by ICTs in the context of primary care for the treatment of mild-moderate depression. Furthermore, specific hypothesis are established; 1) the intervention will be effective after six months of completion of treatment (efficacy measure: PHQ9), 2) the psychological intervention applied through ICTs in primary care will be cost-effective, 3) the acceptability of the intervention will be high by the agents involved: patients, professionals and administrators (results of interviews and focus groups), this acceptability will also be high with regarding the usability of the designed computer system (measured by the System Usability Scale), 4) the data about the use of the platform by patients and professionals will demonstrate that the intervention is adopted, feasible, and high fidelity (modules and tasks completed) and 5) the adequacy of the ICT-supported intervention perceived by professionals, patients andadministrators will be elevated (NoMAD questionnaire and results of interviews and focus groups).The final goal of this study is to demonstrate the feasibility of using the online intervention in order to guarantee that the investment in efficacy research lead to a better care in routine clinical practice and an improvement in public health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The general framework determined for the study design is that indicated by Hermes. A hybrid type II design, where effectiveness and implementation will be evaluated is selected. Regarding the specific design of the empirical study, a stepped wedge (SW) design will be used, which represent a variation of the clinical trials randomized by clusters. All groups receive the treatment but its initiation is done in a randomized order and the treatment is introduced to different groups in a staggered and sequential way. The duration of each phase (e.g. control and treatment), it is determined randomly for each group. The study should be considered a closed cohort, since the same participants will be evaluated over time through a series of time points defined a priori and the inclusion of new participants will not be allowed once the trial has started. sequences will be randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| A B B B B B B B B C C C C C C | Other | Behavioral: "Sonreír es diveritdo" - Smiling is funConsidering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A B B B B B B B B C C C C C C. In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. |
| A A B B B B B B B B C C C C C | Other | Behavioral: "Sonreír es diveritdo" - Smiling is funConsidering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A A B B B B B B B B C C C C C. In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. |
| A A A B B B B B B B B C C C C | Other | Behavioral: "Sonreír es diveritdo" - Smiling is funConsidering the study design of a closed cohort study, the design of this study is composed by 3 sequences (3 different starts of the treatment phase). In this case, the following arm is established as de first arm of the study: A A A B B B B B B B B C C C C. In this sequence A represent the control phase, B the treatment phase and the C the maintenance phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: Over 18 years old.
- DSM-5 Diagnosis of Major Depression.
- Severity of mild or moderate depression (score less than 14 points on PHQ-9).
- Duration of depressive symptoms 2 months or more.
- Availability of computer with Internet connection.
Key exclusion criteria (5 listed)
- Disease affecting the Central Nervous System.
- Other psychiatric diagnosis or illness severe psychiatric (substance dependence and abuse, psychosis, eating disorders, etc.) a exception of anxiety pathology or personality disorders.
- Presence of medical illness, uncontrolled severe degenerative or infectious disease.
- Presence of delusions or hallucinations in the time of study.
- Risk of suicide.
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 |
|---|---|---|
| "Sonreír es diveritdo" - Smiling is funSmiling is Fun is an online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules. The modules and their aims are: 1) Motivation for change; advantages and disadvantages of changing and importance of motivation; 2) Understanding emotional problems; psychoeducational information, maintaining factors and management of medication and sleep hygiene; 3) Learning to get going; behavioural activation strategies; 4) Learning to be flexible; how interpret negative thoughts and situations in a more flexible way; 5) Learning to enjoy; importance of positive emotions and strategies to promote them; 6) Learning to live; how to identify the psychological strengths and importance of doing activities based on values and vital goals; 7) Living and learning; putting into practice the strengths identified in previous module; 8) From now on… what?; a relapse prevention module. | Behavioural | A A A B B B B B B B B C C C C, A A B B B B B B B B C C C C C, A B B B B B B B B C C C C C C |
Primary outcome
Efficacy of the intervention
Time frame: Pre-intervention and immediately after the intervention
Change of depression symtpmatology through the Patient Health Questionnaire-9 (PHQ-9) after the intervention.
6 secondary outcomes
Acceptability
Time frame: Pre-intervention and immediately after the intervention
Acceptability
Time frame: Immediately after the intervention
Adaptation
Time frame: Pre-intervention, immediately after the intervention and follow-up
Adoption, viability and fidelity
Time frame: Pre-intervention and immediately after the intervention
Implementation costs
Time frame: Pre-intervention and immediately after the intervention AND follow-up
Diagnostic Interview
Time frame: Pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Background: PubMed 31133899Mira A, Soler C, Alda M, Banos R, Castilla D, Castro A, Garcia-Campayo J, Garcia-Palacios A, Gili M, Hurtado M, Mayoral F, Montero-Marin J, Botella C. Exploring the Relationship Between the Acceptability of an Internet-Based Intervention for Depression in Primary Care and Clinical Outcomes: Secondary Analysis of a Randomized Controlled Trial. Front Psychiatry. 2019 May 10;10:325. doi: 10.3389/fpsyt.2019.00325. eCollection 2019.
- Background: PubMed 28241025Romero-Sanchiz P, Nogueira-Arjona R, Garcia-Ruiz A, Luciano JV, Garcia Campayo J, Gili M, Botella C, Banos R, Castro A, Lopez-Del-Hoyo Y, Perez Ara MA, Modrego-Alarcon M, Mayoral Cleries F. Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multi-center, three-armed randomized controlled trial conducted in primary care. PLoS One. 2017 Feb 27;12(2):e0172741. doi: 10.1371/journal.pone.0172741. eCollection 2017.
- Background: PubMed 27565118Montero-Marin J, Araya R, Perez-Yus MC, Mayoral F, Gili M, Botella C, Banos R, Castro A, Romero-Sanchiz P, Lopez-Del-Hoyo Y, Nogueira-Arjona R, Vives M, Riera A, Garcia-Campayo J. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial. J Med Internet Res. 2016 Aug 26;18(8):e231. doi: 10.2196/jmir.5695.
- Background: PubMed 25757358Montero-Marin J, Prado-Abril J, Botella C, Mayoral-Cleries F, Banos R, Herrera-Mercadal P, Romero-Sanchiz P, Gili M, Castro A, Nogueira R, Garcia-Campayo J. Expectations among patients and health professionals regarding Web-based interventions for depression in primary care: a qualitative study. J Med Internet Res. 2015 Mar 10;17(3):e67. doi: 10.2196/jmir.3985.
- Background: PubMed 29540243Karyotaki E, Kemmeren L, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJH, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Is self-guided internet-based cognitive behavioural therapy (iCBT) harmful? An individual participant data meta-analysis. Psychol Med. 2018 Nov;48(15):2456-2466. doi: 10.1017/S0033291718000648. Epub 2018 Mar 15.
- Background: PubMed 28241179Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. JAMA Psychiatry. 2017 Apr 1;74(4):351-359. doi: 10.1001/jamapsychiatry.2017.0044.
- Background: PubMed 28408833Mira 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.
- Background: PubMed 25881626Karyotaki E, Kleiboer A, Smit F, Turner DT, Pastor AM, Andersson G, Berger T, Botella C, Breton JM, Carlbring P, Christensen H, de Graaf E, Griffiths K, Donker T, Farrer L, Huibers MJ, Lenndin J, Mackinnon A, Meyer B, Moritz S, Riper H, Spek V, Vernmark K, Cuijpers P. Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis. Psychol Med. 2015 Oct;45(13):2717-26. doi: 10.1017/S0033291715000665. Epub 2015 Apr 17.
- Background: PubMed 27733283GBD 2015 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1603-1658. doi: 10.1016/S0140-6736(16)31460-X.
- BackgroundPakenham-Walsh, Neil. (2004). Learning from one another to bridge the "know-do gap". BMJ. 329. 10.1136/bmj.329.7475.1189.
- Background: PubMed 22179294Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
- Derived from this study: PubMed 42237276Lorente-Catala R, Castro A, Fernandez-Martinez S, Varela-Moreno E, Guerrero-Pertinez G, Forteza-Rey I, Gili M, Lopez-Del-Hoyo Y, Mayoral-Cleries F, Garcia-Campayo J, Garcia-Palacios A. Implementation of an Internet-based psychological intervention for the treatment of mild depression in primary care: a hybrid effectiveness-implementation approach. BMC Public Health. 2026 Jun 3. doi: 10.1186/s12889-026-27573-0. Online ahead of print.
- Individual participant dataSharing planned: Yes
Related trials for Depressive Disorder
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.
Azucena García Palacios principal investigator
University Jaume I
Javier García Campayo principal investigator
Institute of Health Research of Aragon
Margalida Gili principal investigator
Research Institute of Health Sciences, University of Balearic Islands, Palma de Mallorca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Sonreír es diveritdo" - Smiling is fun in people with Depressive Disorder and Depressive Symptoms, run by Universitat Jaume I at 1 site in Spain.
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 7 inclusion and 5 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 1 Jul 2022. 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 Spain. 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 Rosa Lorente Català (0034691527941, rlorente@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the intervention (time frame: Pre-intervention and immediately after the intervention). 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 NCT05294614, which also lists 14 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 1 Jul 2022.