DepressionNCT06230237
Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program to Address Depression
A study testing Smiling is fun + professional support and Smiling is fun in people with Depression, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Depression is a first level problem that poses a challenge for Primary Care (PC). The overload of care in this area requires lower-cost and more accessible alternatives. Internet-based self-applied cognitive behavioral treatments (CBCT) have demonstrated their efficacy and added advantages. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Smiling is fun + professional support and Smiling is fun
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 30 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Ability to understand and read Spanish.
- Meet diagnostic criteria for major depressive disorder (DSM-5).
- Mild or moderate symptoms of the Spanish version of the Beck Depression Inventory-II (BDI-II) (14-19: mild depression; 20-28: moderate depression).
- Episode duration of more than two weeks.
- Have internet access at home and an email account.
- The diagnosis of major depressive disorder will be confirmed by the standardized MINI International Neuropsychiatric Interview.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
Tavernes de la Valldigna, Valencia, 46760
Rosa Lorente Català
About this study
Official title: Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program for the Treatment of Depression
Depression is a first level problem that poses a challenge for Primary Care (PC). The overload of care in this area requires lower-cost and more accessible alternatives. Internet-based self-applied cognitive behavioral treatments (CBCT) have demonstrated their efficacy and added advantages. The "Smiling is fun" program has been validated in Spanish PC and has demonstrated its usefulness and cost-effectiveness. Previous studies have shown that professional support or guidance increases the results of the TCCI.
The aim of the present study is to contrast, by means of a randomized controlled trial, aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support.
Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.
Read the detailed description
Background: Depression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, guided support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. Objective: The current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. Methods: The proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 100 patient participants, with a loss-to-follow-up rate of 30%. Discussion: A study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.
- Conditions
- Depression
- Being tested
- Smiling is fun + professional support, Smiling is fun
- Keywords
- Depression, Internet Based Intervention, Psychological Intervention, Professional Support, Mental Health, Self-guided
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smiling is fun + professional supportBehavioural
Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules.
While they do the online program, they will receive periodically professional support. The professional support will be contacts of 20 minutes long, will take place every two weeks and will last 3 months.
Smiling is funBehavioural
Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules.
| Study group | Role | What they receive |
|---|---|---|
| Professional support | Active comparator | Participants randomly assigned to this groups will receive the self-administered psychotherapy via the Internet a with telephone psychotherapeutic support. Receives: Behavioral: Smiling is fun + professional support |
| Non professional support | Active comparator | Participants randomly assigned to this group will receive the self-administered psychotherapy via the Internet without telephone psychotherapeutic support. Receives: Behavioral: Smiling is fun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Change of depression symtpmatology through the Beck Depression Inventory (BDI-II).
Measured: Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).
Secondary outcomes (1)
Quality of life related to health
The qualitiy of life related to health apsects will be measured using : EuroQol (EQ-5D) and Short Form Health Survey (SF-12)
Measured: Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Francesc de Borja
- Responsible party
- Sponsor
- Investigators
- Azucena García Palacios, Study chair, Universidad Jaume IPedro Vera Albero, Study director, F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de BorjaRaquel Escriva Sanchis, Study chair, F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de BorjaClara Bretó García, Study chair, F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230237
- Sponsor's protocol ID
- FISABIO
- Status last verified
- Jan 2024
- First submitted
- 19 Apr 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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, 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 28408833Lorente-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, Font-Furnieles P, Escriva-Sanchis R, Berto-Garcia C, Vera-Albero P, Garcia-Palacios A. Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial. Internet Interv. 2024 Apr 20;36:100742. doi: 10.1016/j.invent.2024.100742. eCollection 2024 Jun.
PubMed 38737981
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program for the Treatment of Depression
- ClinicalTrials.gov ID
- NCT06230237
- Acronym / sponsor ID
- FISABIO
- Conditions
- Depression
- Keywords
- Depression, Internet Based Intervention, Psychological Intervention, Professional Support, Mental Health, Self-guided
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Hospital Francesc de Borja
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Jan 2024 (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.
Depression is a first level problem that poses a challenge for Primary Care (PC). The overload of care in this area requires lower-cost and more accessible alternatives. Internet-based self-applied cognitive behavioral treatments (CBCT) have demonstrated their efficacy and added advantages. The "Smiling is fun" program has been validated in Spanish PC and has demonstrated its usefulness and cost-effectiveness. Previous studies have shown that professional support or guidance increases the results of the TCCI.
The aim of the present study is to contrast, by means of a randomized controlled trial, aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support.
Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.
Detailed description
Background: Depression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, guided support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. Objective: The current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. Methods: The proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 100 patient participants, with a loss-to-follow-up rate of 30%. Discussion: A study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professional support | Active comparator | Behavioral: Smiling is fun + professional supportParticipants randomly assigned to this groups will receive the self-administered psychotherapy via the Internet a with telephone psychotherapeutic support. |
| Non professional support | Active comparator | Behavioral: Smiling is funParticipants randomly assigned to this group will receive the self-administered psychotherapy via the Internet without telephone psychotherapeutic support. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years.
- Ability to understand and read Spanish.
- Meet diagnostic criteria for major depressive disorder (DSM-5).
- Mild or moderate symptoms of the Spanish version of the Beck Depression Inventory-II (BDI-II) (14-19: mild depression; 20-28: moderate depression).
- Episode duration of more than two weeks.
Key exclusion criteria (0 listed)
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 fun + professional supportParticipants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules. While they do the online program, they will receive periodically professional support. The professional support will be contacts of 20 minutes long, will take place every two weeks and will last 3 months. | Behavioural | Professional support |
| Smiling is funParticipants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules. | Behavioural | Non professional support |
Primary outcome
Treatment efficacy
Time frame: Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).
Change of depression symtpmatology through the Beck Depression Inventory (BDI-II).
1 secondary outcome
Quality of life related to health
Time frame: Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- 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 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.
- Derived from this study: PubMed 42112661Lorente-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.
- Derived from this study: PubMed 38737981Lorente-Catala R, Font-Furnieles P, Escriva-Sanchis R, Berto-Garcia C, Vera-Albero P, Garcia-Palacios A. Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial. Internet Interv. 2024 Apr 20;36:100742. doi: 10.1016/j.invent.2024.100742. eCollection 2024 Jun.
- Individual participant dataSharing planned: Yes
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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 study chair
Universidad Jaume I
Pedro Vera Albero study director
F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
Raquel Escriva Sanchis study chair
F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja
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 + professional support and Smiling is fun in people with Depression, 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 0 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 30 Jan 2024. 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 (691527941 ext. 0034, rlorente@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: Pre-intervention, immediately after the intervention and follow-up (3,6 and 12 months).). 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 NCT06230237, which also lists 8 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 30 Jan 2024.