跳至主要内容
临床试验/NCT06901128
NCT06901128招募中不适用

The Covideo Study - a Randomized Controlled Trial of Cognitive Therapy for Social Anxiety Disorder in Youth, Comparing Screen to Office Delivery

Sykehuset Innlandet HF6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
6
主要终点
Liebowitz social anxiety scale for children and adolescents (LSAS-CA)

研究概览

简要总结

The main goal of this clinical trial is to examine screen delivery as an alternative for offering cognitive therapy to youth with social anxiety. It will examine its effectiveness compared to office delivery, but also its acceptability and sustainability, and identify factors important for the outcome of this approach.

The main questions it aims to answer are:

Does screen delivery show comparable effectiveness to office delivery? Is screen delivery well accepted by youth and therapists? Does screen delivery show economic and climate sustainability? Do credibility and therapeutic alliance predict therapy outcome?

In the study researchers will compare screen delivery to office delivery of cognitive therapy for social anxiety disorders in 200 youth aged 14-18 years.

After an initial screening in schools, eligible youth are assessed with a diagnostic interview. Those meeting inclusion criteria will be offered either screen or office therapy. This is decided by random selection (a draw).

Participants will:

Complete an initial short screening questionnaire. Respond to a diagnostic interview online. Meet their therapist first time in person. Attend 14 weekly 90-minutes therapy session. Complete weekly questionnaires during the therapy. Answer interview and questionnaires after the therapy, and also 6 months, 2 years and 4 years later. Parents are also interviewed and informed of the study.

详细描述

Study aim The main aim of the study is to evaluate screen delivery (SD) as an alternative approach to traditional office delivery (OD) for reaching young people with cognitive therapy (CT) for Social Anxiety Disorder (SAD). In this multi-centre randomized controlled trial (RCT) includes three work packages (WPs), focusing on effectiveness (WP1), acceptability (WP2), health economy and sustainability (WP3), and predictors for outcome (WP4). We aim to show that effectiveness of CT for SD is not inferior compared to OD, that CD is well accepted by youths and therapists, that CD has economic and climate benefits over OD, and we will identify predictors for therapy outcome. SD may represent a novel way of increasing access to effective therapy for young people, leading to improved health and success in education, employment and social life.

Screen delivery (SD) The study originates from the Child and Adolescent Mental Health Services (CAMHS) department at Innlandet Hospital, Norway. Innlandet CAMHS covers a large and mainly rural area, with some clients having long travel distances, and with very limited public transportation. Video communication with patients and families has therefore been of interest to our department over the last decade.

Early into the Covid-19 pandemic, a survey among clinicians in our department found high satisfaction with consultations on screen, especially among younger clinicians (below 40 years of age), and in the treatment of anxiety disorders (after an initial office consultation). A subsequent paper confirmed and extended our findings, noting several potential advantages for SD over OD, including time and cost for travel, logistics, inclusion of "hard to reach" family members, and the possibility to observe clients in their natural setting. This inspired the present study where we examine SD for anxiety in youth.

Public demand and state of the art In 2001 the Norwegian government set a target for at least 15% virtual consultations within the specialist health service. The following year, our four regional health authorities launched a plan for 40% reduction in CO2e-emission by 2030, stating that 20% of consultations should be by screen or telephone. Being the closest analogue to OD, SD may have the potential to reach out to people with effective, acceptable and sustainable mental health interventions. Following more than three decades of research, several online therapy manuals have acquired a solid evidence base. Contrasting this, surprisingly little has been published on SD, especially in light of the surge in its use after the pandemic. Two recent reviews of SD of mental health interventions identified only a single pilot study with adolescents. A review of SD in cognitive behavior therapy (CBT) needed to exclude youth due to lack of studies, urging future original studies to include this age group.

Social Anxiety Disorder SAD is prevalent, with a life-time prevalence around 13%, and a median age of onset of 13 years. Untreated, it follows a chronic course throughout the lifespan, with adverse effects on mental health, education, employment, social life and family life. Treatment is often delayed for years or decades, until those affected develop comorbid depression or substance abuse, and/or drop out of education or work. Social isolation and unstable family life are frequent consequences. Early and easy access to effective treatment is therefore important to prevent such negative impact on mental health and development, and also to reduce school absenteeism in youth which has risen sharply after the pandemic.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Social anxiety disorder primary
  • Age 14 to 18 years.
  • Norwegian fluency

排除标准

  • Severe Depression
  • Acute suicidality
  • Substance abuse
  • Psychosis
  • Intellectual Disability
  • More than 20% absence from school in previous three months

结局指标

主要结局

Liebowitz social anxiety scale for children and adolescents (LSAS-CA)

时间窗: From start of treatment until end of 14 weekly treatment sessions.

24 item scale rated in four response categories

Anxiety and Related Disorders Interview Schedule for DSM-5 Chid and parent Version

时间窗: From start of treatment until end of 14 weekly treatment sessions.

Short name ADIS-5 C/P.

次要结局

  • Revised Children´s Anxiety and Depression Scale RCADS(From start of treatment until end of 14 weekly treatment sessions.)
  • Short Mood and Feelings Questionnaire SMFQ(From start of treatment until end of 14 weekly treatment sessions.)
  • Strengths and Difficulties Questionnaire SDQ(From start of treatment until end of 14 weekly treatment sessions.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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