Cost-effectiveness and Implementation of a Transdiagnostic Internet-based Intervention for Emotional Disorders in Community Care.

NCT07345117 | Not Yet Recruiting

• 1 other identifier: PTon-Terrassa
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Emotional Disorders; Depression Anxiety Disorder; Depression Disorders; Anxiety Disorders

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  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)

  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)

  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).

  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)

  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.

  At the end of the intervention and follow-up at 3, 6, 9 and 12 months.

Study Arms (2)

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).

Behavioral: Internet-based psychological intervention

Treatment as usual (TAU)

ACTIVE COMPARATOR

Standard treatment administered at participating health centers.

Behavioral: Treatment as usual (TAU)

Interventions

Internet-based psychological intervention BEHAVIORAL

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.

Also known as: UJI online transdiagnostic protocol

Transdiagnostic intervention protocol

Treatment as usual (TAU) BEHAVIORAL

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.

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age.
• Meet the diagnostic criteria for an anxiety or depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
• Understand and read Spanish or Catalan.
• Have access to the Internet and an email address
• Give informed consent.

You may not qualify if:

• Diagnosis of schizophrenia, bipolar disorder, or alcohol or substance dependence.
• High risk of suicide.
• Presence of a medical condition that prevents psychological treatment.
• Receiving other psychological treatment (other than TAU or the online program) during the study.
• 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).
• They work at centers participating in the study.
• They agree to participate in the study.
• They sign an informed consent form.

Sponsors & Collaborators

• Hospital Universitari Mutua Terrassa: collaborator
• Universitat Jaume I: lead

Study Sites (1)

Laboratorio de Psicología y Tecnología (LabPsiTec)

Castellon, Castellon, 12071, Spain

Location

Related Publications (4)

• 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.

  PMID: 34401379 BACKGROUND

• Gonzalez-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.

  PMID: 36315227 BACKGROUND

• Diaz-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.

  PMID: 33522977 BACKGROUND

• Gonzalez-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.

  PMID: 32673226 BACKGROUND

Related Links

• Mutua Terrassa website
• LabPsiTec website

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Azucena Garcia-Palacios, Psychology

  Universitat Jaume I

  STUDY DIRECTOR

Central Study Contacts

Monica Conesa-Gimenez, Psychology

CONTACT

+34 646-873-875; conem@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

ES (1)