NCT07051148

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started May 2027

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 26, 2025

Last Update Submit

May 21, 2026

Conditions

Emotional DisordersAnxietyDepression, Unipolar

Keywords

transdiagnosticinternet based therapyanxietydepressionEmotional Disordersadaptive interventionblended treatmentdigital interventionspersonalizationpersonalized treatmentadaptive trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004)

    Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1

  • Inventory of Interpersonal Problems (IIP32, Horowitz, 2000)

    Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1

  • Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al., 2006)

    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)

    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).

    Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  • +5 more secondary outcomes

Other Outcomes (4)

  • Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012).

    Day 1 (BL) Week 3, 12

  • Level of Personal Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0; Weekers et al., 2019).

    Day 1 (BL) Week 3, 12

  • Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).

    Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1

  • +1 more other outcomes

Study Arms (4)

Early responders selfapplied completed

EXPERIMENTAL
Behavioral: UJI Online Transdiagnostic Protocol

Early responders selfapplied interrupted

EXPERIMENTAL
Behavioral: UJI Online Transdiagnostic Protocol

Late responders selfapplied

EXPERIMENTAL
Behavioral: UJI Online Transdiagnostic Protocol

Late responders blended

EXPERIMENTAL
Behavioral: UJI On Line Transdiagnostic Hibrid Protocol

Interventions

UJI Online Transdiagnostic ProtocolBEHAVIORAL

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)

Early responders selfapplied completedEarly responders selfapplied interruptedLate responders selfapplied
UJI On Line Transdiagnostic Hibrid ProtocolBEHAVIORAL

Hybrid format: 12 self applied modules with two synchronous videoconference sessions with a trained therapist

Late responders blended

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressive DisorderDepression

Condition Hierarchy (Ancestors)

Mental DisordersMood DisordersBehavioral SymptomsBehavior

Central Study Contacts

Fernanda Longo Elia, Psychologist

CONTACT

+541159643668FERLONGO1@GMAIL.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multivarate experimental adaptive design (2 factors, 4 groups). Randomization will occur after the initial intervention phase (first 3 modules), based on symptom reduction using a Reliable Change Index (RCI). Participants will be classified as early or late responders. Within each group, simple randomization (1:1) will be implemented using a computer-generated sequence (in R). Assignment will be managed by and external researcher blind to clinical staff, using preloaded, password-protected lists. No stratification by sex, age or sociocultural status will be applied.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2025

First Posted

July 3, 2025

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

July 1, 2030

Last Updated

May 27, 2026

Record last verified: 2026-05