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Emotional DisordersNCT07051148

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

A study testing UJI Online Transdiagnostic Protocol and UJI On Line Transdiagnostic Hibrid Protocol in people with Emotional Disorders and Anxiety, run by Universitat Jaume I.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Emotional Disorders, Anxiety, Depression, Unipolar
What is being tested?
UJI Online Transdiagnostic Protocol and UJI On Line Transdiagnostic Hibrid Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
No sites listed yet
Study dates
1 May 2027to Jul 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fernanda Longo Elia, Psychologist contact

+541159643668

FERLONGO1@GMAIL.COM

About this study

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.

Read the 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.

Being tested
UJI Online Transdiagnostic Protocol, UJI On Line Transdiagnostic Hibrid Protocol
Keywords
transdiagnostic, internet based therapy, anxiety, depression, Emotional Disorders, adaptive intervention, blended treatment, digital interventions, personalization, personalized treatment, adaptive trial
Medical subject headings
Anxiety Disorders, Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UJI Online Transdiagnostic ProtocolBehavioural

    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 ProtocolBehavioural

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

Study groups in NCT07051148
Study groupRoleWhat they receive
Early responders selfapplied completedExperimentalNot described
Receives: Behavioral: UJI Online Transdiagnostic Protocol
Early responders selfapplied interruptedExperimentalNot described
Receives: Behavioral: UJI Online Transdiagnostic Protocol
Late responders selfappliedExperimentalNot described
Receives: Behavioral: UJI Online Transdiagnostic Protocol
Late responders blendedExperimentalNot described
Receives: Behavioral: UJI On Line Transdiagnostic Hibrid Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: Day 1 (BL) Week 1, 2, 4, 5, 7, 8, 10, 11

Secondary outcomes (10)

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

    Self- report 28-items questionnaire with 5 Likert response options. The scale assesses emotion regulation process and several difficulties associated. Adapted and validated in Spain with sound psychometric properties reported -internal consistency, test-retest reliability, convergent and incremental validity.

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

  2. Inventory of Interpersonal Problems (IIP32, Horowitz, 2000)

    Is is a self-report questionnaire designed to assess interpersonal difficulties experienced over the past month. It covers eight dimensions of interpersonal functioning (e.g., being too controlling, socially inhibited, or self-sacrificing). Each item is rated on a 5-point Likert scale. The IIP-32 is a widely validated and efficient tool for identifying interpersonal patterns relevant to psychological distress and treatment planning.

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

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

    Self-report 5-item questionnaire that assesses frequency and severity of anxiety symptoms during the previous week. With 5 Likert response options (from 0 to 4). Adapted in Spain with good internal consistency (α = .86) and test-retest reliability (k= .84)

    Measured: Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1

  4. Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al., 2014)

    Self-report 5-item questionnaire with 5 Likert response options (from 0 to 4). Assesses frequency and severity of depression symptoms during the previous week. Adapted in Spain with excellent psychometrics properties, internal consistency (α = .93) and convergent and discriminant validity

    Measured: Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1

  5. Working Alliance Inventory for Internet Interventions (WAI-I; Gómez Penedo et al., 2020).

    12-items self-report questionnaire with 5 Likert response options. Assesses working alliance in internet-based interventions. Validated in German sample of adults with depressive symptoms receiving guided online intervention

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

  6. Emotional Processing Self Report (EP-SR; Fisher et al., 2025)

    Self-report 7-items questionnaire with 5 Likert response options. Assesses emotional processing during therapeutic sessions in three independent dimensions: emotional expression, regulation and understanding emotional meaning. The instrument demonstrates adequate psychometrics properties, with internal consistency, convergent, incremental and predictive validity in clinical sample. It has not yet been validated in Spanish speaking population.

    Measured: Week 3, 6, 9, 12 Week 25 Year 1

  7. Unified Protocol Skill Use Scale (UPSUS; Southward, & Sauer-Zavala, 2022)

    Self-report 7-items questionnaire with 7 Likert response options. Assesses the use of emotional regulation skills from Barlow's Unified Protocol (UP). Adapted for Spanish speaking population

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

  8. Brief Positive and Negative Affect Schedule (Brief PANAS; Watson et al., 1988

    Self-report 10-items questionnaire with 5 Likert response options (1 to 5). Assesses positive and negative affectivity (trait/state) during the past few weeks. Adapted for Spanish speaking population

    Measured: Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  9. Quality of Life Index Spanish (QLI-Sp; Mezzich et al., 2000)

    Self-report questionnaire containing 10 ítems with 10 Likert response options. Assess physical and emotional wellbeing, social support, interpersonal functioning, personal satisfaction and overall assessment of quality of life. Validated in Spanish speaking population with adequate psychometric properties in clinical sample (α = .87).

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

  10. Generalized Self-Efficacy Scale (GSES; Jerusalem & Schwarzer, 1992).

    Self-report 10-items questionnaire with 4-point Likert scale. Assesses general sense of perceived self-efficacy. Validated in Spanish speaking population with sound psychometric properties

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start1 May 2027 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07051148
Sponsor's protocol ID
TRANSBLEND
Status last verified
May 2026
First submitted
26 May 2025
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Longo Elia F, Garcia-Palacios A, Botella C, Gomez Penedo JM, Grosse Holtforth M, Berger T, Fernandez-Alvarez J. Efficacy of a personalized, response-based transdiagnostic intervention for emotional disorders delivered via the Internet: a protocol for an adaptive randomized controlled trial. Front Psychiatry. 2026 Sep 21;17:1918892. doi: 10.3389/fpsyt.2026.1918892. eCollection 2026.

    PubMed 42865738

Questions about this trial

What is this clinical trial studying?

A study testing UJI Online Transdiagnostic Protocol and UJI On Line Transdiagnostic Hibrid Protocol in people with Emotional Disorders and Anxiety, run by Universitat Jaume I.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fernanda Longo Elia, Psychologist (+541159643668, FERLONGO1@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07051148, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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