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临床试验/NCT03873155
NCT03873155已完成不适用

The Effectiveness of Mindfulness Based Cognitive Group Therapy for Social Anxiety Symptoms in People Living With Alopecia Areata: A Single Group Case Series.

University of Sheffield3 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2019年3月14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
6
试验地点
3
主要终点
Change in social anxiety (idiosyncratic measure)

研究概览

简要总结

This study investigates the impact of mindfulness based cognitive therapy (MBCT) on social anxiety in adults with alopecia areata. A single-group case-series design will be adopted.

详细描述

Alopecia areata (AA) is an immunological disorder which is characterised by round/oval patches of non-scarring hair loss. People living with AA are at higher risk of developing depression, anxiety and social phobia than the general population (Koo et al., 1994; Ruiz-Doblado, Carrizosa, & García-Hernández, 2003). Interventions that aim to reduce engagement in negative appearance related thoughts, and attentional bias towards negative self-referential information may be helpful for this population.

Mindfulness-based cognitive therapy (MBCT) offers one potential method of reducing social anxiety in individuals with AA. MBC is a structured eight-week programme that has been recommended by the National Institute of Clinical Excellence as an effective intervention to reduce the risk of relapse in depression since 2009.

The main aim of the current study is to investigate whether an MBCT course can reduce social anxiety in individuals with AA. A single-group case-series design will be adopted, whereby participants will act as their own control; data collected from participants during and after they have received the intervention will be compared to data collected before they have received the intervention. Semi-structured interviews will be carried out at the end of the study to investigate participants experiences of the intervention.

The investigators predict that MBCT will reduce social anxiety in individuals with AA. More specifically, the hypothesis are:

(i) participants will experience an increase in mindfulness during the intervention period, relative to the baseline phase and this will be maintained at follow-up

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

盲法说明

No party will be masked in this study. There is only one arm and participants will act as their own controls

入排标准

年龄范围
16 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AA is the main presenting physical health problem
  • Participant self-identifies as experiencing social anxiety
  • Sufficient English to participate in group sessions and discussion.
  • Aged 16 and over

排除标准

  • Primary psychiatric diagnosis affecting skin (e.g., trichotillomania)
  • Hair loss as a result of medical intervention or surgery (e.g., chemotherapy)
  • The skin condition is secondary to other physical health problems (e.g., arthritis, cancer, chronic pain)
  • Patient does not report any social distress as a result of their AA
  • Currently undergoing other psychological therapy

研究组 & 干预措施

Mindfulness-based cognitive therapy

Experimental

There is only one arm in this study. A range of variables will first be measured (daily and weekly) over a baseline period in a group of participants. Following this baseline period, participants will be take part in an MBCT intervention whilst the same variables are measured. Following the intervention,there will be a 4-week follow-up period, and MBCT groups will not run during this time.

干预措施: Mindfulness Based Cognitive Therapy (Behavioral)

结局指标

主要结局

Change in social anxiety (idiosyncratic measure)

时间窗: Daily for 20 weeks (baseline-intervention-follow-up)

The primary outcome measures for the proposed study are idiosyncratic measures of social anxiety which will be assessed daily by text message. Participants will be asked to identify one social anxiety-related positive target (something the participant would like to improve) and one negative target (something the participant would like to reduce). Participants will respond to the daily text messages with a score on a 0-100 scale

次要结局

  • Social Anxiety(Weekly for 21 weeks (baseline-intervention-follow-up))
  • Depression(4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later))
  • Anxiety(4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later))
  • Quality of life (dermatology-related)(4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later))
  • Service use(3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later))
  • Mindfulness(4 time-points. Assessment (beginning of study) beginning of intervention (4 weeks later) end of intervention (9 weeks later) follow-up (8 weeks later))
  • Work and social adjustment(3-time points. 4 time-points. Beginning of intervention (4 weeks after assessment) end of intervention (9 weeks later) follow-up (8 weeks later))

研究者

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

Andrew Thompson

Principal Investigator

University of Sheffield

研究点 (3)

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