Efficacy of a Personalized, Response-based Transdiagnostic Intervention for Emotional Disorders Delivered Via the Internet: A Protocol for an Adaptive Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 366
- 主要终点
- Clinical Outcomes in Routine Evaluation (CORE-34, Evans et al., 2002)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spanish speakers
- •OASIS score +/= 8
- •ODSIS score +/= 7
- •Access to Internet
排除标准
- •Severe mental disorder: schizophrenia/bipolar disorder
- •Active substance abuse
- •High suicide risk
- •Ongoing psychological/pharmacological treatment
- •Interfering physical illness
研究组 & 干预措施
Late responders blended
干预措施: UJI On Line Transdiagnostic Hibrid Protocol (Behavioral)
Early responders selfapplied completed
干预措施: UJI Online Transdiagnostic Protocol (Behavioral)
Early responders selfapplied interrupted
干预措施: UJI Online Transdiagnostic Protocol (Behavioral)
Late responders selfapplied
干预措施: UJI Online Transdiagnostic Protocol (Behavioral)
结局指标
主要结局
Clinical Outcomes in Routine Evaluation (CORE-34, Evans et al., 2002)
时间窗: 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)
时间窗: 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.
次要结局
- Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004)(Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1)
- Inventory of Interpersonal Problems (IIP32, Horowitz, 2000)(Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1)
- 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)
- 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)
- 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)
- 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)
- Emotional Processing Self Report (EP-SR; Fisher et al., 2025)(Week 3, 6, 9, 12 Week 25 Year 1)
- Unified Protocol Skill Use Scale (UPSUS; Southward, & Sauer-Zavala, 2022)(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Quality of Life Index Spanish (QLI-Sp; Mezzich et al., 2000)(Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1)
- Generalized Self-Efficacy Scale (GSES; Jerusalem & Schwarzer, 1992).(Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1)