ClinicalTrials.Veeva

Menu

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

U

Universitat Jaume I

Status

Not yet enrolling

Conditions

Emotional Disorders
Depression, Unipolar
Anxiety

Treatments

Behavioral: UJI On Line Transdiagnostic Hibrid Protocol
Behavioral: UJI Online Transdiagnostic Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT07051148
TRANSBLEND

Details and patient eligibility

About

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 sympron 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.

Full 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 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

Enrollment

366 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Spanish speakers
  • PHQ 9 score + 5
  • GAD 7 score + 5
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

366 participants in 4 patient groups

Early responders selfapplied completed
Experimental group
Treatment:
Behavioral: UJI Online Transdiagnostic Protocol
Early responders selfapplied interrupted
Experimental group
Treatment:
Behavioral: UJI Online Transdiagnostic Protocol
Late responders selfapplied
Experimental group
Treatment:
Behavioral: UJI Online Transdiagnostic Protocol
Late responders blended
Experimental group
Treatment:
Behavioral: UJI On Line Transdiagnostic Hibrid Protocol

Trial contacts and locations

0

Loading...

Central trial contact

Fernanda Longo Elia, Psychologist

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems