NCT Number: NCT07051148
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Hybrid format: 12 self applied modules with two synchronous videoconference sessions with a trained therapist
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: Day 1 (BL) Week 3, 12
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
Time frame: Day 1 (BL) Week 3, 12
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
Time frame: Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
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
Time frame: Week 3
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.
Contact information is provided by the study sponsor or research team.
Universitat Jaume I
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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