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临床试验/NCT03205839
NCT03205839已完成不适用

Effectiveness of Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety: a Pilot Randomised Controlled Trial

University of Sheffield1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2017年7月27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
284
试验地点
1
主要终点
Comprehensive assessment of Acceptance and Commitment Therapy processes

研究概览

简要总结

The acceptance and commitment therapy (ACT) model theoretically fits with treating appearance-related anxiety in individuals with a visible difference. This study examines the effectiveness of an acceptance-based self-help manual for this population.

详细描述

Individuals with visible difference commonly experience social anxiety due to appearance-related concerns. There are limited resources to help people with appearance-related distress, so internet-provided self-help interventions may be beneficial. A pilot randomised controlled trial will compare the effectiveness of an acceptance-based self-help intervention to a waitlist control group.

We hypothesise (1) the acceptance-based self-help intervention will significantly increase participants' "psychological flexibility", (2) significantly decrease fear of negative evaluation from others and (3) significantly increase their quality of life, compared to the waitlist control group. Data will be collected at two time points only.

General distress (CORE-10) will be collected pre-intervention only to ensure randomisation has been successful. Should the two groups significantly differ in distress, this will be accounted for in subsequent analyses.

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
None

盲法说明

Entire study completed online, including randomisation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Individuals who self-identify as having a visible difference to their appearance (such as, but not restricted to: hair and skin conditions, burns, craniofacial conditions, birthmarks, surgical scarring)
  • •Must self-define as experiencing concerns about social interaction or a loss of social confidence in relation to their visible difference.
  • •Must be aged 18 years or over
  • •Must be fluent in English language
  • •Must have access to a computer and the internet

排除标准

  • •Currently receiving any form of psychotherapy

研究组 & 干预措施

Acceptance-based self-help

Experimental

Participants in this group will receive the self-help booklet.

Surviving to Thriving: ACT self-help for living well with a visible difference in appearance

干预措施: Acceptance-based self-help intervention (Behavioral)

Waitlist control group

No Intervention

Participants in this group will be placed onto a waitlist for the four-week intervention period.

结局指标

主要结局

Comprehensive assessment of Acceptance and Commitment Therapy processes

时间窗: Four weeks

A general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.

次要结局

  • Work and Social Adjustment Scale (WSAS)(Four weeks)
  • Brief Fear of Negative Evaluation Scale II (BFNE-II)(Four weeks)

研究者

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

Luke Powell

Trainee Clinical Psychologist

University of Sheffield

研究点 (1)

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