跳至主要内容
临床试验/NCT07129941
NCT07129941招募中不适用

Transdiagnostic Group Treatment of Emotional Disorders: A Cross-sectional and Naturalistic Study of Outcome, Change Processes, and Clinical Training

University of Bergen2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
WHO-5: Wellbeing index

研究概览

简要总结

This clinical trial aims to evaluate the effectiveness and underlying processes of change of the Unified Protocol (UP) for treating emotional disorders in a university outpatient clinic. The study will involve 140 patients receiving UP treatment in a group format, delivered either by experienced or novice therapists, along with a non-clinical control group of 45 participants. Participants will self-refer on the basis of advertisement about the study through flyers, posters, project website, social media or local news media. Outcomes will be assessed through self-report measures of well-being, symptoms, emotion regulation, and the non-specific factors of treatment credibility and therapeutic alliance. Additionally, psychophysiological measures of heart rate variability and interoception will be used to explore processes influencing treatment response. Qualitative interviews will complement the quantitative data by capturing participants' perspectives on the treatment and experiences of what contributed to change.

详细描述

Background Anxiety and depression are the most common mental disorders, incurring vast personal and societal costs. While effective evidence-based treatments exist, healthcare systems struggle to meet the growing demand for services. A key challenge in delivering care is that most treatments are diagnosis specific. This complicates training and implementation due to clinicians having to learn multiple treatment manuals. In addition, these single-disorder treatments may also often have poor applicability to the complex symptoms and patterns of comorbidity typically seen in real-world clinical settings. As a response to these challenges, several transdiagnostic treatment protocols have been developed to target psychological processes underlying different diagnoses. One such model is the "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP) developed by David Barlow and colleagues. UP addresses the functional processes that maintain emotional disorders, such as negative reactions to emotions and avoidance behaviors.

The Unified Protocol (UP) has shown non-inferiority to diagnosis-specific CBT and superiority to treatment as usual in both individual and group formats. Meta-analyses confirm its effectiveness for comorbid emotional disorders and suggest potential for cost-effective, scalable implementation.

Knowledge gaps

  • Norwegian Setting: Only one small feasibility study of UP has been conducted in Norway. A larger naturalistic trial is needed to assess outcomes (quality of life, functioning, symptoms) and potential negative effects in a public health context.
  • Processes of Change: More research is needed to identify active treatment mechanisms (e.g., emotion regulation, mindfulness, cognitive flexibility) and their association with outcomes in group UP. Non-specific factors such as credibility and group alliance also require investigation.
  • Psychophysiological Measures: UP's impact on objective emotion regulation markers (e.g., heart rate variability, interoception) is unexplored. Inclusion of such measures can reduce bias and clarify underlying mechanisms.
  • Novice Therapists: The ability of graduate psychology students to deliver UP with high fidelity in group format remains unclear and merits further investigation.

Study objectives This study aims to explore outcomes, processes of change, and user experiences of UP group treatment for patients with emotional disorders in a naturalistic clinical sample in a Norwegian setting. Additionally, it will compare the clinical sample to a healthy control group to better understand how transdiagnostic characteristics serve as vulnerability or resilience factors in the development of emotional disorders. Lastly, the study examines whether novice therapists can be trained to deliver the treatment with high levels of fidelity based on ratings of adherence and competence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-40
  • Fulfilling diagnostic criteria for an anxiety disorder and/or unipolar depression (ICD F.3x - 4x)
  • Motivated for short-term treatment in group format

排除标准

  • Suicidality
  • Self-harm
  • Severe psychiatric disorder (bipolar disorder, psychosis)
  • Substance use disorders
  • Use of anxiolytic medication (i.e., benzodiazepines)
  • Unstable antidepressant medication (i.e., stable dosage <6 months)
  • Other ongoing psychological treatment

结局指标

主要结局

WHO-5: Wellbeing index

时间窗: From enrollment to follow-up at 6 months

The WHO-5 is a self-report measure of positive mental health. It consists of five items that are rated on a 6-point scale from 'All of the time' to 'At no time'. High scores indicate a more positive rating of wellbeing

次要结局

  • Difficulty in Emotion Regulation Scale (DERS-16)(From enrollment to follow-up at 6 months)
  • Acceptance and Action Questionnaire- version 2 (AAQ-II)(From enrollment to follow-up at 6 months)
  • Five Facet Mindfulness Questionnaire (FFMQ)(From enrollment to follow-up at 6 months)
  • Unified Protocol Cognitive Skills Questionnaire (UP-CSQ)(From enrollment to follow-up at 6 months)
  • Multidimensional Assessment of Interoceptive Awareness-2 (MAIA)(From enrollment to follow-up at 6 months)
  • Overall Anxiety Severity and Impairment Scale (OASIS)(At each treatment session through the 12 weeks of treatment)
  • Unified Protocol Skill Use Scale (UPSUS)(At each treatment session through the 12 weeks of treatment)
  • Dimension of Skillfulness and Use Scale (DSUS)(At each treatment session through the 12 weeks of treatment)
  • Work and Social Adjustment Scale(From enrollment to follow-up at 6 months)
  • Patient Health Questionnaire (PHQ-9)(From enrollment to follow-up at 6 months)
  • Generalized Anxiety Disorder Scale (GAD-7)(From enrollment to follow-up at 6 months)
  • Multidimensional Emotional Disorders Inventory (MEDI)(From enrollment to follow-up at 6 months)
  • Level of Personality Functioning Scale Brief Form (LPFS-BF)(From enrollment to follow-up at 6 months)
  • Overall Depression Severity and Impairment Scale (ODSIS)(At each treatment session through the 12 weeks of treatment)
  • Client Satisfaction Questionnaire (CSQ-8)(At final treatment session (week 12))
  • The Negative Effects Questionnaire (NEQ)(At final treatment session (week 12))
  • The Heartbeat Counting Task (HBC)(From enrollment to follow-up at 6 months)
  • Heart Rate Variability (HRV) via a 24-hour ECG Monitoring.(From enrollment to follow-up at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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