Efficacy of a Personalized, Response-based Transdiagnostic Intervention for Emotional Disorders Delivered Via the Internet: A Protocol for an Adaptive Randomized Controlled Trial

This adaptive randomized controlled trial evaluates the efficacy of a transdiagnostic, internet-delivered psychological intervention for emotional disorders, tailored to patient´s early clinical response. 366 adults with clinically significant symptoms of depression and/or anxiety will begin a 12 module self-applied program. Based on sympton reduction after the first three modules, participants will be classified as early or late responders and randomized into different experimental arms. The main hypothesis is that a hybrid format (self-applied modules plus synchronous sessions with a therapist) will yield better outcomes for late responders. Outcomes include symptom reduction, emotional regulation and internet based therapheutic alliance.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Depression, Unipolar; Emotional Disorders
• Intervention / Treatment: Behavioral: UJI Online Transdiagnostic Protocol; Behavioral: UJI On Line Transdiagnostic Hibrid Protocol

Detailed Description

To assess its effectiveness, two formats will be compared: the original, consisting of 12 self-administered modules, and a hybrid format, which includes two synchronous videoconference sessions with a trained therapist. Early responders will either continue with the original intervention or discontinue treatment; while late responders will receive the hybrid format or continue with the original intervention. The primary expected result is that the hybrid format will improve treatment outcomes for late responders compared to the self-applied format. The findings are expected to inform clinical practice by highlighting the importance of assessing symptomatic response throughout treatment, especially in its early phases.

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernanda Longo Elia, Psychologist; Phone Number: +541159643668; Email: FERLONGO1@GMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Spanish speakers
• OASIS score +/= 8
• ODSIS score +/= 7
• Access to Internet
• Email

Exclusion Criteria:

• Severe mental disorder: schizophrenia/bipolar disorder
• Active substance abuse
• High suicide risk
• Ongoing psychological/pharmacological treatment
• Interfering physical illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early responders selfapplied completed	Behavioral: UJI Online Transdiagnostic Protocol; Is a manualized treatment for emotional disorders delivered through an interactive multimedia platform. The self applied format consists of 12 self applied modules (psychoeducation, emotional processing, cognitive flexibility training, exposure, coping strategies, maladaptive behaviors, avoidance, etc)
Experimental: Early responders selfapplied interrupted	Behavioral: UJI Online Transdiagnostic Protocol; Is a manualized treatment for emotional disorders delivered through an interactive multimedia platform. The self applied format consists of 12 self applied modules (psychoeducation, emotional processing, cognitive flexibility training, exposure, coping strategies, maladaptive behaviors, avoidance, etc)
Experimental: Late responders selfapplied	Behavioral: UJI Online Transdiagnostic Protocol; Is a manualized treatment for emotional disorders delivered through an interactive multimedia platform. The self applied format consists of 12 self applied modules (psychoeducation, emotional processing, cognitive flexibility training, exposure, coping strategies, maladaptive behaviors, avoidance, etc)
Experimental: Late responders blended	Behavioral: UJI On Line Transdiagnostic Hibrid Protocol; Hybrid format: 12 self applied modules with two synchronous videoconference sessions with a trained therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes in Routine Evaluation (CORE-34, Evans et al., 2002)	Is a self report questionnaire designed to assess psychological distress and global functioning across four domains: subjective well being, problems/symptoms, functioning and risk. Items are rated on a 5 point Likert scale. The instrument has demostrated good psychometrics properties. Higher scores indicate greater psychological distress.	Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Clinical Outcomes in Routine Evaluation 10 (CORE 10, Barkham et al., 2013)	Is a Self-report 10-items questionnaire with 5 Likert response options. Assess general distress. Validated for Spanish speaking population with adequate internal consistency, convergent validity and sensitivity to change.	Day 1 (BL) Week 1, 2, 4, 5, 7, 8, 10, 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004)	Self- report 28-items questionnaire with 5 Likert response options. The scale assesses emotion regulation process and several difficulties associated. Adapted and validated in Spain with sound psychometric properties reported -internal consistency, test-retest reliability, convergent and incremental validity.	Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Inventory of Interpersonal Problems (IIP32, Horowitz, 2000)	Is is a self-report questionnaire designed to assess interpersonal difficulties experienced over the past month. It covers eight dimensions of interpersonal functioning (e.g., being too controlling, socially inhibited, or self-sacrificing). Each item is rated on a 5-point Likert scale. The IIP-32 is a widely validated and efficient tool for identifying interpersonal patterns relevant to psychological distress and treatment planning.	Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al., 2006)	Self-report 5-item questionnaire that assesses frequency and severity of anxiety symptoms during the previous week. With 5 Likert response options (from 0 to 4). Adapted in Spain with good internal consistency (α = .86) and test-retest reliability (k= .84)	Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1
Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al., 2014)	Self-report 5-item questionnaire with 5 Likert response options (from 0 to 4). Assesses frequency and severity of depression symptoms during the previous week. Adapted in Spain with excellent psychometrics properties, internal consistency (α = .93) and convergent and discriminant validity	Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1
Working Alliance Inventory for Internet Interventions (WAI-I; Gómez Penedo et al., 2020).	12-items self-report questionnaire with 5 Likert response options. Assesses working alliance in internet-based interventions. Validated in German sample of adults with depressive symptoms receiving guided online intervention	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Emotional Processing Self Report (EP-SR; Fisher et al., 2025)	Self-report 7-items questionnaire with 5 Likert response options. Assesses emotional processing during therapeutic sessions in three independent dimensions: emotional expression, regulation and understanding emotional meaning. The instrument demonstrates adequate psychometrics properties, with internal consistency, convergent, incremental and predictive validity in clinical sample. It has not yet been validated in Spanish speaking population.	Week 3, 6, 9, 12 Week 25 Year 1
Unified Protocol Skill Use Scale (UPSUS; Southward, & Sauer-Zavala, 2022)	Self-report 7-items questionnaire with 7 Likert response options. Assesses the use of emotional regulation skills from Barlow's Unified Protocol (UP). Adapted for Spanish speaking population	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Brief Positive and Negative Affect Schedule (Brief PANAS; Watson et al., 1988	Self-report 10-items questionnaire with 5 Likert response options (1 to 5). Assesses positive and negative affectivity (trait/state) during the past few weeks. Adapted for Spanish speaking population	Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Quality of Life Index Spanish (QLI-Sp; Mezzich et al., 2000)	Self-report questionnaire containing 10 ítems with 10 Likert response options. Assess physical and emotional wellbeing, social support, interpersonal functioning, personal satisfaction and overall assessment of quality of life. Validated in Spanish speaking population with adequate psychometric properties in clinical sample (α = .87).	Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Generalized Self-Efficacy Scale (GSES; Jerusalem & Schwarzer, 1992).	Self-report 10-items questionnaire with 4-point Likert scale. Assesses general sense of perceived self-efficacy. Validated in Spanish speaking population with sound psychometric properties	Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012).	Self-report 31-items questionnaire with 5-point Likert scale which assesses maladaptive personality traits proposed in the DSM-5. Validated in Spanish speaking population with adequate psychometric properties	Day 1 (BL) Week 3, 12
Level of Personal Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0; Weekers et al., 2019).	Self-report 12-items questionnaire with 4-point Likert response options. Asseses levels of personality functioning according to the alternative model of personality disorders of DSM-5. There is Spanish version available	Day 1 (BL) Week 3, 12
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).	Self-report questionnaire with Likert scale responses from 0 to 100%. Assesses treatment outcome expectations (patient subscale). High internal consistency (α =.79 -.90). Test-retest reliability: r = .82 for expectancy, r = .75 for credibility. Used in Spanish clinical trials with good results	Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
System Usability Scale (SUS; Brooke, 1996).	Self-report 10-items questionnaire with 5-point Likert scale (1 to 5). Good psychometric properties (α = .91, Lewis, 2018). Validated in Spain with adequate psychometric properties (Castilla et al., 2023). Assesses usability of a digital program or tool.	Week 3

Collaborators and Investigators

• Sponsor: Universitat Jaume I

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: May 26, 2025
• First Submitted That Met QC Criteria: June 26, 2025
• First Posted (Actual): July 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: depression; anxiety; personalized treatment; Emotional Disorders; digital interventions; transdiagnostic; internet based therapy; personalization; adaptive intervention; blended treatment; adaptive trial
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Behavior; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: TRANSBLEND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No