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.
Spanish speakers
OASIS score +/= 8
ODSIS score +/= 7
Access to Internet
Severe mental disorder: schizophrenia/bipolar disorder
Active substance abuse
High suicide risk
Ongoing psychological/pharmacological treatment
Parallel
UJI Online Transdiagnostic Protocol
BehavioralIs 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
BehavioralHybrid format: 12 self applied modules with two synchronous videoconference sessions with a trained therapist
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.
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.
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.
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.
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)
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
Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012).
Self-report 31-items questionnaire with 5-point Likert scale which assesses maladaptive personality traits proposed in the DSM-5. Validated in Spanish speaking population with adequate psychometric properties
Level of Personal Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0; Weekers et al., 2019).
Self-report 12-items questionnaire with 4-point Likert response options. Asseses levels of personality functioning according to the alternative model of personality disorders of DSM-5. There is Spanish version available
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
Self-report questionnaire with Likert scale responses from 0 to 100%. Assesses treatment outcome expectations (patient subscale). High internal consistency (α =.79 -.90). Test-retest reliability: r = .82 for expectancy, r = .75 for credibility. Used in Spanish clinical trials with good results
System Usability Scale (SUS; Brooke, 1996).
Self-report 10-items questionnaire with 5-point Likert scale (1 to 5). Good psychometric properties (α = .91, Lewis, 2018). Validated in Spain with adequate psychometric properties (Castilla et al., 2023). Assesses usability of a digital program or tool.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
