Anxiety, Depression, Unipolar, Emotional Disorders
Conditions
Keywords
transdiagnostic, internet based therapy, anxiety, depression, Emotional Disorders, adaptive intervention, blended treatment, digital interventions, personalization, personalized treatment, adaptive trial
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.
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.
Interventions
BEHAVIORALUJI 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)
BEHAVIORALUJI On Line Transdiagnostic Hibrid Protocol
Hybrid format: 12 self applied modules with two synchronous videoconference sessions with a trained therapist
Sponsors
Universitat Jaume I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Spanish speakers * OASIS score +/= 8 * ODSIS score +/= 7 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes in Routine Evaluation (CORE-34, Evans et al., 2002) | Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1 | 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. |
| Clinical Outcomes in Routine Evaluation 10 (CORE 10, Barkham et al., 2013) | Day 1 (BL) Week 1, 2, 4, 5, 7, 8, 10, 11 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004) | Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1 | 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. |
| Inventory of Interpersonal Problems (IIP32, Horowitz, 2000) | Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1 | 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. |
| 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 | 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) |
| 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 | 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 |
| 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 | 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 |
| Emotional Processing Self Report (EP-SR; Fisher et al., 2025) | Week 3, 6, 9, 12 Week 25 Year 1 | 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. |
| Unified Protocol Skill Use Scale (UPSUS; Southward, & Sauer-Zavala, 2022) | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 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 |
| Brief Positive and Negative Affect Schedule (Brief PANAS; Watson et al., 1988 | Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 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 |
| Quality of Life Index Spanish (QLI-Sp; Mezzich et al., 2000) | Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1 | 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). |
| Generalized Self-Efficacy Scale (GSES; Jerusalem & Schwarzer, 1992). | Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1 | 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 |
Contacts
CONTACTFernanda Longo Elia, Psychologist
Outcome results
None listed