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Not yet recruiting NCT07051148

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

No phase Interventional Emotional Disorders Anxiety Depression, Unipolar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UJI Online Transdiagnostic Protocol, UJI On Line Transdiagnostic Hibrid Protocol.
Who it may be relevant to
Registry conditions: Emotional Disorders, Anxiety, Depression, Unipolar. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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)
  • Behavioral UJI On Line Transdiagnostic Hibrid Protocol
    Hybrid format: 12 self applied modules with two synchronous videoconference sessions with a trained therapist

Primary outcome measures

  • Clinical Outcomes in Routine Evaluation (CORE-34, Evans et al., 2002) [Time frame: Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1]
  • Clinical Outcomes in Routine Evaluation 10 (CORE 10, Barkham et al., 2013) [Time frame: Day 1 (BL) Week 1, 2, 4, 5, 7, 8, 10, 11]
Secondary outcome measures (10)
  • Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004) [Time frame: Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1]
  • Inventory of Interpersonal Problems (IIP32, Horowitz, 2000) [Time frame: Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1]
  • Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al., 2006) [Time frame: 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) [Time frame: 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). [Time frame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
  • Emotional Processing Self Report (EP-SR; Fisher et al., 2025) [Time frame: Week 3, 6, 9, 12 Week 25 Year 1]
  • Unified Protocol Skill Use Scale (UPSUS; Southward, & Sauer-Zavala, 2022) [Time frame: 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 [Time frame: 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) [Time frame: Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1]
  • Generalized Self-Efficacy Scale (GSES; Jerusalem & Schwarzer, 1992). [Time frame: Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07051148 · TRANSBLEND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗