From research to clinical practice: Implementation of an Internet-based transdiagnostic treatment program for emotional disorders in primary care
| ISRCTN | ISRCTN11689312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11689312 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PTon-Terrassa |
| Sponsors | Laboratorio de Psicología y Tecnología (LABPSITEC), Hospital Universitari Mutua Terrassa |
| Funder | Investigator initiated and funded |
- Submission date
- 31/10/2025
- Registration date
- 26/11/2025
- Last edited
- 26/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The World Health Organization (WHO) defines mental health as a state where every individual realizes their potential, can cope with life's stresses, can work productively, and can contribute to their community. Unfortunately, many people do not achieve or maintain this state of well-being. When this happens, it often manifests as a mental disorder, with depressive and anxiety disorders being the most common. In Spain, around 6% of the population experience these conditions, which can seriously affect people’s personal, social, and work lives. The COVID-19 pandemic has also increased awareness of mental health and the need for accessible and effective treatments.
Although effective psychological and drug treatments exist, only a small percentage of people actually receive adequate care. For example, a recent study found that only 23% of people with depression in high-income countries and 3% in middle-income countries receive sufficient treatment. This shows that mental health is not only a health issue but also a social and ethical challenge.
Possible solutions include increasing the number of mental health professionals and organizing services more efficiently, from prevention to specialized care. In this regard, one possible solution is to use online psychological treatments, which research has shown to be as effective as face-to-face therapy for people with moderate depression and anxiety disorders.
The main objective of this project is to optimize mental health services by incorporating an online treatment program to increase citizens' access to effective psychological treatments. Specifically, the study aims to test how effective and cost-efficient the "UJI online transdiagnostic protocol" is compared to the usual treatment patients receive. It also aims to explore how acceptable and practical it is for both patients and professionals, and what barriers or facilitators exist for successfully integrating the "UJI online transdiagnostic protocol" into mental health services.
If successful, this project could make psychological treatment more accessible, helping people receive care earlier and more conveniently, and allowing professionals to focus face-to-face resources on those with more severe conditions.
Who can participate?
Participants will be adult patients (age range ≥18 years) of both sexes from the two mental health centers managed by Mutua Terrassa. They can only participate if they have a clinical diagnosis of moderate depression and/or anxiety disorders. Healthy volunteers and people with severe mental health conditions that require intensive or specialized treatment will not take part in this study
What does the study involve?
The study is a clinical trial that will compare the effectiveness and costs of:
1. The online intervention: Participants will receive the "UJI online transdiagnostic protocol", an interactive, web-based psychological treatment. This is a program developed and validated by the Universitat Jaume I (UJI) that uses a transdiagnostic approach (meaning it addresses common symptoms shared by different disorders like depression and anxiety). The aim of the program is to help people learn skills to manage depression and anxiety symptoms by focusing on emotions, thoughts, and behaviors that are common across different mental health problems. The program is structured into several modules and includes exercises and feedback from professionals.
2. Treatment As Usual (TAU): Participants will receive the standard treatment offered at Mutua Terrassa, which may include face-to-face therapy, medication, or other types of support, depending on the patient’s needs.
Not all participants will receive the same treatment; they will be randomly assigned to one of the two comparison groups.
Throughout the study, researchers will measure:
• The effectiveness of the treatments (measuring the reduction of depression and anxiety symptoms in the short and long term).
• The costs involved (economic efficiency).
• The opinions and satisfaction of both patients and mental health professionals regarding the implementation of the online program.
• An analysis of the barriers and facilitators (what helps and what hinders) the sustained incorporation of the online program into the services.
What are the possible benefits and risks of participating?
Possible Benefits:
• Access to an Evidence-Based Treatment: Participants assigned to the online treatment group will receive a program that has been rigorously validated in clinical trials and shown to be effective for depression and anxiety. This format may also be more flexible and easier to integrate into their daily lives.
• Symptom Improvement: All participants have the chance to experience a significant improvement in their depression and/or anxiety symptoms, regardless of the treatment group they are assigned to.
• Contributing to Better Healthcare: By participating, individuals will help determine the usefulness and sustainability of an affordable and scalable treatment alternative. Positive results could lead to the widespread adoption of this program, significantly improving mental health care access for many others in the future.
Possible Risks:
• Risk of Not Receiving the New Treatment: Participants assigned to the TAU group will not directly benefit from the new online alternative. However, they will receive the standard care already available at the center and will be given access to the online treatment at the end of the study.
• Potential Emotional Discomfort: As with any form of psychological therapy, the process (both online and face-to-face) involves confronting difficult thoughts and emotions, which may temporarily cause some emotional distress or discomfort.
• Technology Reliance: For the online treatment group, participation requires access to and comfort using mobile technology and a reliable internet connection.
Where is the study run from?
The study is a collaborative effort between the Universitat Jaume I (UJI) and Mutua Terrassa, which is implementing the program within its two mental health centres serving over 200,000 inhabitants.
When is the study starting and how long is it expected to run for?
The study is expected to start in 2026 and will run for approximately two years. This period includes participant recruitment, delivery of the treatment, and follow-up assessments to measure both short-term and long-term effects.
Who is funding the study?
The study is funded through a collaboration between Universitat Jaume I (UJI) and Mutua Terrassa (Spain).
Who is the main contact?
Monica Conesa Gimenez
PhD student at LABPSITEC
conem@uji.ee
Contact information
Public, Scientific
Edificio Investigación II, Despacho NB2126DL - Av. Vicente Sos Baynat, s/n
Castellon de la Plana
12071
Spain
 ORCID ID |
0009-0000-1611-8968 |
|---|---|
| Phone | +34 646873875 |
| conem@uji.es |
Principal investigator
Edificio Investigación II, Despacho NB2126DL - Av. Vicente Sos Baynat, s/n
Castellon de la Plana
12071
Spain
| ORCID ID |
0000-0001-9250-8714 |
|---|---|
| Phone | +34 636523487 |
| azucena@uji.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional non-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Cost-effectiveness and implementation of a transdiagnostic Internet-based intervention for emotional disorders in community care |
| Study acronym | TREAT-ED |
| Study objectives | 1.The implementation strategy (training protocol) will be assessed by professionals as a valid strategy for implementing the online treatment, increasing scores on adoption measures (attitudes toward evidence-based treatments and online treatments) after receiving training and at the end of their participation in the empirical study. 2. The online treatment will be equally effective as the treatment as usual (TAU) in the short term (post-test) and long term (3, 6, 9, and 12-month follow-ups): reduction in depressive symptoms, anxiety, and negative affect, and increase in positive affect and quality of life in the post-test, with maintenance of gains in the follow-ups. 3. The online treatment will be cost-effective. Compared to the treatment as usual, the application of online treatment will result in a significant reduction in direct and indirect costs, as well as in professional time, and a faster return of patients from specialized care to primary care. 4. The online treatment will receive positive scores in implementation measures assessed by patients and professionals (scales, interviews, and focus groups) and obtained through analysis of data on the use of the technological platform (program entries and module completion): acceptability, adequacy, feasibility, adoption, barriers, and facilitators. |
| Ethics approval(s) |
Approved 27/05/2025, Fundació Assistencial Mútua Terrassa Comité Ètic D’investigació Amb Medicaments (Pl/ Doctor Robert, 5, planta -1, Terrassa, 08221, Spain; +34 937365050; ceim@mutuaterrassa.cat), ref: P/25-083 |
| Health condition(s) or problem(s) studied | Treatment of emotional disorders: depression and anxiety disorders |
| Intervention | Arm 1: Experimental - 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). 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. Arm 2: Active Comparator - 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 the online treatment. Recruitment of 200 participants: Mental health professionals from Mutua Terrassa will be responsible for recruiting participants among patients referred by primary care providers who meet the study’s inclusion criteria. Professionals will identify potential participants and present the study’s characteristics with the help of a description study sheet, ensuring that any questions are addressed and that participants fully understand the study procedures. Those who agree to participate voluntarily will sign an informed consent form. Subsequently, professionals will conduct a detailed assessment to verify compliance with the inclusion criteria and will notify a researcher, who will perform the random allocation of participants to study conditions using dedicated software. The assignment results will then be communicated to the participating professionals. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Depression severity and impairment is measured using the Spanish version of the Overall Depression Severity and Impairment Scale (ODSIS) at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months |
| Key secondary outcome measure(s) |
Implementation outcomes: |
| Completion date | 01/01/2029 |
Eligibility
| Participant type(s) | Health professional, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Patients: 1. Over 18 years of age 2. Meet the diagnostic criteria for an anxiety or depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) 3. Understand and read Spanish or Catalan 4. Have access to the Internet and an email address 5. Give informed consent Mental Health Professionals: 1. They work at centers participating in the study 2. They agree to participate in the study 3. They sign an informed consent form |
| Key exclusion criteria | Patients: 1. Diagnosis of schizophrenia, bipolar disorder, or alcohol or substance dependence 2. High risk of suicide 3. Presence of a medical condition that prevents psychological treatment 4. Receiving other psychological treatment (other than TAU or the online program) during the study 5. For participants in the online treatment condition with pharmacological treatment, this must be stabilized (doses cannot be changed or increased during the study, only reduced) |
| Date of first enrolment | 15/01/2026 |
| Date of final enrolment | 15/01/2027 |
Locations
Countries of recruitment
- Spain
Study participating centres
Terrassa
08221
Spain
Castellon de la Plana
12071
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicy available repository (Open Science Framework) |
Editorial Notes
03/11/2025: Trial's existence confirmed by Fundació Assistencial Mútua Terrassa Comité Ètic D’investigació Amb Medicaments.
