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临床试验/NCT03514225
NCT03514225已完成不适用

Metacognitive Therapy for Social Anxiety in Youth: A Systematic Replication Series

University of Manchester2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Social Phobia and Anxiety Inventory for Children (SPAI-C; Beidel et al., 1995)

研究概览

简要总结

Social anxiety disorder (SAD) is a fear of social situations that involve interacting with other people. Although it can be very upsetting, there are ways to help people deal with it. This study aims to explore the use of a new treatment called Metacognitive Therapy (MCT) for social anxiety in children and teenagers. MCT is a one-to-one talking therapy which works by changing people's patterns of attention and thinking in social situations. By doing this, people with SAD can begin to feel more confident and less anxious when interacting with others.

Findings suggests that MCT works well when treating adults who have social anxiety. However, this treatment has not yet been used with young people. This study hopes to explore whether MCT can help treat SAD in children and teenagers. This information will help us to plan larger studies in the future.

People who would like to take part in this study will be asked to fill in some questionnaires once a week for at least 2 weeks and return these to the researcher in the post. Following this, they will be offered 8 weekly sessions of MCT at their local Child and Adolescent Mental Health Service. Each session will last for about 1 hour. This will involve talking to a clinician about how they think and feel when in social situations, and filling in some more questionnaires. This will allow us to see how their social anxiety changes week-by-week and whether this has improved by the end of treatment (week 8).

1-months after people have had their last session of MCT, they will be asked to complete and return a final set of questionnaires through the post. This will allow us to get a final measure of their social anxiety and see whether any changes in SAD have been maintained.

Primary Questions:

  • Is MCT a feasible and acceptable treatment for social anxiety disorder within a child and adolescent population?
  • Is MCT associated with improvements in SAD symptoms and functioning?

Secondary Questions:

  • Are benefits associated with MCT replicable across subtypes of social anxiety disorder (general and specific)?
  • Are any gains associated with MCT for social anxiety disorder maintained at 1 month follow up?

详细描述

A systematic case replication series utilising an A-B design with 1-month follow-up will be used within this study to replicate MCT intervention across SAD subtypes. (A = no treatment baseline; B = 8 weekly one-one sessions of MCT). This design was chosen as MCT is a relatively novel approach to SAD, particularly within a child and adolescent population.

Recruitment:

Potential participants will be identified by CAMHS Clinicians during routine clinical practice. If the Anxiety Disorders Interview Schedule-IV Child/Parent Version indicates clinical severity of SAD, individuals will be invited to participate in the full study.

This study aims to recruit 5 participants experiencing social anxiety disorder. Participants who drop out of the study during the baseline phase (i.e. before receiving any sessions of MCT intervention) will be replaced by another eligible participant who will be recruited in their place. However, any participants who drop out during the intervention phase of the study will not be replaced.

Phase 1 (Baseline):

研究设计

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

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants must meet criteria for SAD on the ADIS-IV
  • Participants must be aged between 13-17 years old at the time of consent
  • SAD must be their primary presenting problem (generalised or specific subtype)
  • Participants may or may not be taking medication for a mental health difficulty as long as this remains stable during the study
  • Participants may or may not have received previous psychological intervention for SAD as long as this is not ongoing

排除标准

  • They are aged 18 or above or under the age of 13 at the time of consent
  • SAD is not their primary presenting problem
  • They are currently undergoing other forms of psychological intervention for SAD or other mental health difficulties [other interventions would need to be suspended for the duration of the study]
  • They have a diagnosis of autism spectrum disorder, attention deficit hyperactivity disorder or a learning disability which would impair their ability to participate
  • They are non-English speaking
  • They are currently demonstrating a high level of risk to themselves or others
  • Although participants may also experience low mood, this must not be severe enough to warrant treatment in its own right

研究组 & 干预措施

Metacognitive Therapy for Social Anxiety

Other

Exact sessional content of the MCT intervention is likely to involve attention training and situational attentional refocussing techniques, verbal reattribution strategies aimed to facilitate a reduction of self-processing strategies and to challenge metacognitive beliefs, and between-session tasks for participants to practice at home.

干预措施: Metacognitive Therapy for Social Anxiety (Other)

结局指标

主要结局

Social Phobia and Anxiety Inventory for Children (SPAI-C; Beidel et al., 1995)

时间窗: Change in overall SPAI-C score from baseline to 8 weeks post-baseline (end of intervention)

A 26-item measure of social anxiety, assessing assertiveness, general conversation, physical and cognitive symptoms, avoidance and public performance.

次要结局

  • Revised Social Phobia Rating Scale (R-SPRS)(Change in R-SPRS scores from baseline to 1 month follow-up)
  • Social Phobia and Anxiety Inventory for Children (SPAI-C; Beidel et al., 1995)(Change in overall SPAI-C score from baseline to 1 month follow-up)
  • Revised Children's Anxiety and Depression Scale (RCADS; Chorpita et al.,2000)(Weekly during baseline, once approximately 8 weeks post-baseline (end of the intervention), and once at 1 month follow-up)
  • Treatment completion(Proportions to be calculated at the end of the intervention phase of the study (11-14 weeks after 1st baseline measure, depending on length of baseline))
  • Proportion of missed appointments (DNAs)(Proportion of DNAs to be calculated at the end of the intervention phase (11-14 weeks after 1st baseline measure, depending on length of baseline))
  • Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001)(Weekly during baseline, once approximately 8 weeks post-baseline (end of the intervention), and once at 1 month follow-up)
  • Session Feedback Questionnaire (SFQ; Evidence Based Practice Unit, 2012)(Intervention session 1 (4-6 weeks after 1st baseline measure, dependent on length of baseline), session 4 (7-10 weeks after 1st baseline measure) and session 8 (11-14 weeks after 1st baseline measure).)
  • Drop-out rates(Proportions to be calculated at the end of the intervention phase (11-14 weeks after 1st baseline measure, depending on length of baseline))
  • Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)(Intervention session 2 (4-7 weeks after 1st baseline measure, dependent on length of baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Wells

Professor of Clinical and Experimental Psychopathology

University of Manchester

研究点 (2)

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