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

Sponsor
Universitat Jaume I
Study ID
NCT07051148
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Depression, Unipolar
  • Emotional Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 3, 2025
Start date
May 1, 2027
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
366 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early responders selfapplied completed
  • Experimental: Early responders selfapplied interrupted
  • Experimental: Late responders selfapplied
  • Experimental: Late responders blended

Primary Outcome Measure

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 ]

Central Contacts

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