Emotional DisordersTREAT-EDNCT07345117
Cost-effectiveness and Implementation of a Transdiagnostic Internet-based Intervention for Emotional Disorders in Community Care.
A study testing Internet-based psychological intervention and Treatment as usual (TAU) in people with Emotional Disorders and Depression Anxiety Disorder, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorders, Depression Anxiety Disorder, Depression Disorders
- What is being tested?
- Internet-based psychological intervention and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- They work at centers participating in the study.
- They agree to participate in the study.
- They sign an informed consent form.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Laboratorio de Psicología y Tecnología (LabPsiTec)
Castellon, Castellon, 12071
Monica Conesa Gimenez, Psychology, +34 646873875, conem@uji.es
Azucena Garcia Palacios, Psychology
About this study
Official title: From Research to Clinical Practice: Implementation of an Internet-based Transdiagnostic Treatment Program for Emotional Disorders in Primary Care (TREAT-ED)
Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. The need for cost-effective solutions has led to the consideration of the transdiagnostic approach and the use of digital solutions. Both perspectives have demonstrated efficacy in a large number of randomized clinical trials. As a result, investment in digital health interventions is on the rise to improve access to care in overburdened healthcare systems. However, their integration and implementation in health systems remains limited. Implementation Science emerges to facilitate the integration of interventions into clinical practice through specific strategies that overcome barriers and optimize their sustainability. The objective of this project is to examine the effectiveness, economic costs and feasibility of implementing an online psychological treatment program for emotional disorders in mental health services. The Mutua and UJI teams have already carried out the transfer of the online program. In order to facilitate the adoption and sustainability of this program and that it can be used by mental health professionals in daily practice, a hybrid design 1 study will be carried out in which not only the efficacy but also the possibility of adoption and the analysis of economic costs in comparison with the usual treatment will be evaluated.
Read the detailed description
The World Health Organization (WHO) defines mental health as "a state of well-being in which every individual realizes his or her potential, can cope with the stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community." Many people do not achieve this state of well-being, or even if they do, they lose it at some point in their lives. When this happens, it can take the form of a mental disorder, the most prevalent being depressive and anxiety disorders, which affect around 6% of the population in Spain, causing a major impact on their social, work, and personal lives. In the wake of the COVID pandemic, there has been greater awareness in society of the importance of mental health.
However, despite this and despite the availability of effective pharmacological and psychological treatments that can significantly alleviate the symptoms of many mental disorders, health systems are not responding adequately to people with mental disorders. A study exploring mental health care in 84 countries, including Spain (Moitra et al., 2022), found that only 23% of people with depression in high-income countries and 3% in middle-income countries received minimally adequate treatment for their problem. This indicates that the problem goes beyond a health issue; it is a social and ethical problem, since without adequate treatment, many mental disorders have very negative consequences that significantly reduce well-being, satisfaction, and quality of life and cause social inequalities.
Possible solutions include increasing the number of professionals and organizing the provision of services more efficiently, from prevention to specialized care, including primary care. In this regard, there is a very solid line of research that has shown that online psychological treatments are as effective as face-to-face treatments for people with moderate depression and anxiety disorders. This project is part of the objective of optimizing mental health services by incorporating an online treatment program in order to increase citizens' access to effective psychological treatments.
The researchers involved in this application form a team that combines healthcare work with scientific work in order to implement an online transdiagnostic treatment program, going beyond individual face-to-face therapy, increasing diversity in the ways psychotherapy is administered, being flexible, and expanding the range of services offered. The team at the Universitat Jaume I (UJI) has developed and validated the "UJI online transdiagnostic protocol" in rigorous clinical trials and with the collaboration of affected individuals (user-centered design), which is effective in the short and long term for depression and anxiety. Over the past year, the UJI team and the Mutua Terrassa team, through a transfer agreement, have integrated the program into Mutua's technology platform. This application aims to promote the adoption and sustainability of this program as an additional alternative available to mental health professionals at the two mental health centers run by Mutua Terrassa, which serve a population of more than 200,000 inhabitants.
The idea is to offer this program to people with moderate depression and/or anxiety so that professionals can intensify face-to-face care for other patients with more serious conditions. A clinical trial will be conducted to compare the effectiveness and costs of the online program with the usual treatment received by patients. In addition, the opinions of professionals and patients about the program will be evaluated, and the barriers and facilitators of incorporating the online program into services will be analyzed. The results will indicate the usefulness of this alternative. If the results are positive, an affordable, evidence-based alternative will be available that will increase the scope and scalability of treatments, which will be more integrated into people's daily lives, expanding the settings in which interventions are provided, with the acceptance of those involved. The project's actions include a plan to disseminate the results to society through social media networks belonging to both the UJI and Mutua; the organization of a specific conference on the project's results for primary care and specialist professionals at Mutua and another conference for patient and user associations; and holding meetings with managers who can make decisions about the sustainability of the program and its adoption in other services (General Directorate of Mental Health of the Valencian Community, management, health, and executive boards of Catsalut).
- Being tested
- Internet-based psychological intervention, Treatment as usual (TAU)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based psychological interventionBehavioural
Also called UJI online transdiagnostic protocol
This protocol consists of a set of techniques that have proven effective in improving the lives of people with emotional disorders and is designed to be applied via the Internet. Its objective is to teach strategies that improve the ability to regulate emotions in a more adaptive way.
It includes the following core therapeutic components, aimed primarily at regulating negative affect: a) emotional awareness focused on the present moment and acceptance, b) cognitive flexibility, c) emotional and behavioral avoidance, and d) exposure to emotional experiences (interoceptive and situational). In addition, the protocol also includes traditional evidence-based components for the treatment of emotional disorders, such as psychoeducation, motivation for change, and relapse prevention. Finally, it also includes a specific component for regulating positive affect, with the aim of promoting psychological strengths and improving well-being.
Treatment as usual (TAU)Behavioural
TAU may include pharmacological treatment (antidepressants and/or anxiolytics), psychological treatments (case management, group therapy, empathic listening, and counseling and advice), mental health nursing follow-up with psychosocial interventions, or a combination thereof. Participants in TAU and receiving treatment outside the center will be excluded from the study. The specific treatment received by each patient will be recorded. After the study, TAU participants will be given access to online treatment.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic intervention protocol | Experimental | Internet-based psychological intervention (UJI online transdiagnostic protocol). This protocol, based on the transdiagnostic perspective, offers the possibility of applying a single psychological treatment for different emotional disorders by proposing that these disorders share a common vulnerability which, associated with certain stress factors, gives rise to different manifestations of this vulnerability (depression and various anxiety disorders). Receives: Behavioral: Internet-based psychological intervention |
| Treatment as usual (TAU) | Active comparator | Standard treatment administered at participating health centers. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of effectiveness of the intervention in reducing depressive symptoms using the Overall Depression Severity and Impairment Scale (ODSIS)
Scores equal to or greater than 5 discriminate patients with clinical depressive symptoms.
Measured: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of effectiveness of the intervention in reducing anxiety symptoms using the Overall Anxiety Severity and Impairment Scale (OASIS)
Scores equal to or greater than 7 discriminate patients with symptoms of clinical anxiety.
Measured: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of effectiveness of the intervention in improving positive and negative affect using the Positive and Negative Affect Scale (PANAS)
2 subscales: Negative and Positive Affect. Higher scores in each subscale indicates more neuroticism and positive affect, respectively.
Measured: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of effectiveness of the intervention in improving quality of life using the EuroQoL-5D-3L
This questionnaire describes health status in terms of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) according to five levels of severity. The experimental group will experience a more substantial improvement in quality of life compared to the TAU group, as evidenced by superior outcomes on the European Quality of Life 5D (EUROQOL).
Measured: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Secondary outcomes (11)
Level of acceptability of the intervention using the System Usability Scale (SUS)
Cut-off: a score of 68 and higher is considered acceptable usability.
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of acceptability of the intervention using the Acceptability of Intervention Measure (AIM)
Cut-off scores for interpretation are not yet available; however, higher scores indicate greater acceptability.
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of acceptability of the intervention using the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I).
Cut-off scores for interpretation are not yet available; however, higher scores indicate greater client satisfaction and acceptability.
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of feasibility of the intervention using the Feasibility of Intervention Measure (FIM)
Cut-off scores for interpretation are not yet available; however, higher scores indicate greater feasibility.
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of feasibility of the intervention using passive data collected by the platform.
Program usage metrics (module completion, dropout, and frequency of use).
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of appropriateness of the intervention using the Intervention Appropriateness Measure (IAM)
Cut-off scores for interpretation are not yet available; however, higher scores indicate greater appropriateness.
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Barriers and facilitators to intervention implementation measured quantitatively with the Pragmatic Context Assessment Tool (pCAT)
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Barriers and facilitators to intervention implementation measured qualitatively with semi-structured interviews and focus groups
Following the Consensual Qualitative Research (CQR) guidelines
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Cost analysis - Initial technology investment costs
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Cost analysis - Direct costs using the ICT-P adult questionnaire
Measured: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Cost analysis - Indirect costs using the Productivity Costs Questionnaire (iPCQ)
Measured: At the end of the intervention and follow-up at 3, 6, 9 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 posted15 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Emotional DisordersStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Responsible party
- Sponsor
- Investigators
- Azucena Garcia-Palacios, Psychology, Study director, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345117
- Sponsor's protocol ID
- PTon-Terrassa
- Acronym
- TREAT-ED
- Status last verified
- Mar 2026
- First submitted
- 24 Sep 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Robles A, Suso-Ribera C, Diaz-Garcia A, Garcia-Palacios A, Castilla D, Botella C. Predicting response to transdiagnostic iCBT for emotional disorders from patient and therapist involvement. Internet Interv. 2021 Jun 20;25:100420. doi: 10.1016/j.invent.2021.100420. eCollection 2021 Sep.
PubMed 34401379Gonzalez-Robles A, Roca P, Diaz-Garcia A, Garcia-Palacios A, Botella C. Long-term Effectiveness and Predictors of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Emotional Disorders in Specialized Care: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2022 Oct 31;9(10):e40268. doi: 10.2196/40268.
PubMed 36315227Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Alvarez J, Castilla D, Breton JM, Banos RM, Quero S, Botella C. Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Feb 1;23(2):e21335. doi: 10.2196/21335.
PubMed 33522977Gonzalez-Robles A, Diaz-Garcia A, Garcia-Palacios A, Roca P, Ramos-Quiroga JA, Botella C. Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 7;22(7):e18220. doi: 10.2196/18220.
PubMed 32673226
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Research to Clinical Practice: Implementation of an Internet-based Transdiagnostic Treatment Program for Emotional Disorders in Primary Care (TREAT-ED)
- ClinicalTrials.gov ID
- NCT07345117
- Acronym / sponsor ID
- TREAT-ED / PTon-Terrassa
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 15 Jan 2026 (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.
Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. The need for cost-effective solutions has led to the consideration of the transdiagnostic approach and the use of digital solutions. Both perspectives have demonstrated efficacy in a large number of randomized clinical trials. As a result, investment in digital health interventions is on the rise to improve access to care in overburdened healthcare systems. However, their integration and implementation in health systems remains limited. Implementation Science emerges to facilitate the integration of interventions into clinical practice through specific strategies that overcome barriers and optimize their sustainability. The objective of this project is to examine the effectiveness, economic costs and feasibility of implementing an online psychological treatment program for emotional disorders in mental health services. The Mutua and UJI teams have already carried out the transfer of the online program. In order to facilitate the adoption and sustainability of this program and that it can be used by mental health professionals in daily practice, a hybrid design 1 study will be carried out in which not only the efficacy but also the possibility of adoption and the analysis of economic costs in comparison with the usual treatment will be evaluated.
Detailed description
The World Health Organization (WHO) defines mental health as "a state of well-being in which every individual realizes his or her potential, can cope with the stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community." Many people do not achieve this state of well-being, or even if they do, they lose it at some point in their lives. When this happens, it can take the form of a mental disorder, the most prevalent being depressive and anxiety disorders, which affect around 6% of the population in Spain, causing a major impact on their social, work, and personal lives. In the wake of the COVID pandemic, there has been greater awareness in society of the importance of mental health.
However, despite this and despite the availability of effective pharmacological and psychological treatments that can significantly alleviate the symptoms of many mental disorders, health systems are not responding adequately to people with mental disorders. A study exploring mental health care in 84 countries, including Spain (Moitra et al., 2022), found that only 23% of people with depression in high-income countries and 3% in middle-income countries received minimally adequate treatment for their problem. This indicates that the problem goes beyond a health issue; it is a social and ethical problem, since without adequate treatment, many mental disorders have very negative consequences that significantly reduce well-being, satisfaction, and quality of life and cause social inequalities.
Possible solutions include increasing the number of professionals and organizing the provision of services more efficiently, from prevention to specialized care, including primary care. In this regard, there is a very solid line of research that has shown that online psychological treatments are as effective as face-to-face treatments for people with moderate depression and anxiety disorders. This project is part of the objective of optimizing mental health services by incorporating an online treatment program in order to increase citizens' access to effective psychological treatments.
The researchers involved in this application form a team that combines healthcare work with scientific work in order to implement an online transdiagnostic treatment program, going beyond individual face-to-face therapy, increasing diversity in the ways psychotherapy is administered, being flexible, and expanding the range of services offered. The team at the Universitat Jaume I (UJI) has developed and validated the "UJI online transdiagnostic protocol" in rigorous clinical trials and with the collaboration of affected individuals (user-centered design), which is effective in the short and long term for depression and anxiety. Over the past year, the UJI team and the Mutua Terrassa team, through a transfer agreement, have integrated the program into Mutua's technology platform. This application aims to promote the adoption and sustainability of this program as an additional alternative available to mental health professionals at the two mental health centers run by Mutua Terrassa, which serve a population of more than 200,000 inhabitants.
The idea is to offer this program to people with moderate depression and/or anxiety so that professionals can intensify face-to-face care for other patients with more serious conditions. A clinical trial will be conducted to compare the effectiveness and costs of the online program with the usual treatment received by patients. In addition, the opinions of professionals and patients about the program will be evaluated, and the barriers and facilitators of incorporating the online program into services will be analyzed. The results will indicate the usefulness of this alternative. If the results are positive, an affordable, evidence-based alternative will be available that will increase the scope and scalability of treatments, which will be more integrated into people's daily lives, expanding the settings in which interventions are provided, with the acceptance of those involved. The project's actions include a plan to disseminate the results to society through social media networks belonging to both the UJI and Mutua; the organization of a specific conference on the project's results for primary care and specialist professionals at Mutua and another conference for patient and user associations; and holding meetings with managers who can make decisions about the sustainability of the program and its adoption in other services (General Directorate of Mental Health of the Valencian Community, management, health, and executive boards of Catsalut).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic intervention protocol | Experimental | Behavioral: Internet-based psychological interventionInternet-based psychological intervention (UJI online transdiagnostic protocol). This protocol, based on the transdiagnostic perspective, offers the possibility of applying a single psychological treatment for different emotional disorders by proposing that these disorders share a common vulnerability which, associated with certain stress factors, gives rise to different manifestations of this vulnerability (depression and various anxiety disorders). |
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usual (TAU)Standard treatment administered at participating health centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- They work at centers participating in the study.
- They agree to participate in the study.
- They sign an informed consent form.
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 |
|---|---|---|
| Internet-based psychological interventionAlso: UJI online transdiagnostic protocolThis protocol consists of a set of techniques that have proven effective in improving the lives of people with emotional disorders and is designed to be applied via the Internet. Its objective is to teach strategies that improve the ability to regulate emotions in a more adaptive way. It includes the following core therapeutic components, aimed primarily at regulating negative affect: a) emotional awareness focused on the present moment and acceptance, b) cognitive flexibility, c) emotional and behavioral avoidance, and d) exposure to emotional experiences (interoceptive and situational). In addition, the protocol also includes traditional evidence-based components for the treatment of emotional disorders, such as psychoeducation, motivation for change, and relapse prevention. Finally, it also includes a specific component for regulating positive affect, with the aim of promoting psychological strengths and improving well-being. | Behavioural | Transdiagnostic intervention protocol |
| Treatment as usual (TAU)TAU may include pharmacological treatment (antidepressants and/or anxiolytics), psychological treatments (case management, group therapy, empathic listening, and counseling and advice), mental health nursing follow-up with psychosocial interventions, or a combination thereof. Participants in TAU and receiving treatment outside the center will be excluded from the study. The specific treatment received by each patient will be recorded. After the study, TAU participants will be given access to online treatment. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Level of effectiveness of the intervention in reducing depressive symptoms using the Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Scores equal to or greater than 5 discriminate patients with clinical depressive symptoms.
Level of effectiveness of the intervention in reducing anxiety symptoms using the Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Scores equal to or greater than 7 discriminate patients with symptoms of clinical anxiety.
Level of effectiveness of the intervention in improving positive and negative affect using the Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
2 subscales: Negative and Positive Affect. Higher scores in each subscale indicates more neuroticism and positive affect, respectively.
Level of effectiveness of the intervention in improving quality of life using the EuroQoL-5D-3L
Time frame: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
This questionnaire describes health status in terms of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) according to five levels of severity. The experimental group will experience a more substantial improvement in quality of life compared to the TAU group, as evidenced by superior outcomes on the European Quality of Life 5D (EUROQOL).
11 secondary outcomes
Level of acceptability of the intervention using the System Usability Scale (SUS)
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of acceptability of the intervention using the Acceptability of Intervention Measure (AIM)
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of acceptability of the intervention using the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I).
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of feasibility of the intervention using the Feasibility of Intervention Measure (FIM)
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of feasibility of the intervention using passive data collected by the platform.
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Level of appropriateness of the intervention using the Intervention Appropriateness Measure (IAM)
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Barriers and facilitators to intervention implementation measured quantitatively with the Pragmatic Context Assessment Tool (pCAT)
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Barriers and facilitators to intervention implementation measured qualitatively with semi-structured interviews and focus groups
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Cost analysis - Initial technology investment costs
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Cost analysis - Direct costs using the ICT-P adult questionnaire
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Cost analysis - Indirect costs using the Productivity Costs Questionnaire (iPCQ)
Time frame: At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 34401379Gonzalez-Robles A, Suso-Ribera C, Diaz-Garcia A, Garcia-Palacios A, Castilla D, Botella C. Predicting response to transdiagnostic iCBT for emotional disorders from patient and therapist involvement. Internet Interv. 2021 Jun 20;25:100420. doi: 10.1016/j.invent.2021.100420. eCollection 2021 Sep.
- Background: PubMed 36315227Gonzalez-Robles A, Roca P, Diaz-Garcia A, Garcia-Palacios A, Botella C. Long-term Effectiveness and Predictors of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Emotional Disorders in Specialized Care: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2022 Oct 31;9(10):e40268. doi: 10.2196/40268.
- Background: PubMed 33522977Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Alvarez J, Castilla D, Breton JM, Banos RM, Quero S, Botella C. Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Feb 1;23(2):e21335. doi: 10.2196/21335.
- Background: PubMed 32673226Gonzalez-Robles A, Diaz-Garcia A, Garcia-Palacios A, Roca P, Ramos-Quiroga JA, Botella C. Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 7;22(7):e18220. doi: 10.2196/18220.
- Mutua Terrassa websiteLink provided by the sponsor.
- LabPsiTec websiteLink provided by the sponsor.
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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.
Azucena Garcia-Palacios, Psychology study director
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based psychological intervention and Treatment as usual (TAU) in people with Emotional Disorders and Depression Anxiety Disorder, 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 3 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: opening soon, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Conesa-Gimenez, Psychology (+34 646-873-875, conem@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of effectiveness of the intervention in reducing depressive symptoms using the Overall Depression Severity and Impairment Scale (ODSIS) (time frame: Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.). The study lists 4 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 NCT07345117, which also lists 4 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 18 Mar 2026.