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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Emotional Disorders Anxiety Depression, Unipolar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Early responders selfapplied completed

Group Type EXPERIMENTAL

UJI Online Transdiagnostic Protocol

Intervention Type 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)

Early responders selfapplied interrupted

Group Type EXPERIMENTAL

UJI Online Transdiagnostic Protocol

Intervention Type 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)

Late responders selfapplied

Group Type EXPERIMENTAL

UJI Online Transdiagnostic Protocol

Intervention Type 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)

Late responders blended

Group Type EXPERIMENTAL

UJI On Line Transdiagnostic Hibrid Protocol

Intervention Type BEHAVIORAL

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

Interventions

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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)

Intervention Type BEHAVIORAL

UJI On Line Transdiagnostic Hibrid Protocol

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No