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临床试验/NCT04104724
NCT04104724Unknown不适用

A Feasibility Study of a Compassion-focused Self-help Intervention Designed to Increase Access to Cervical Screening Following Sexual Assault

Royal Holloway University0 个研究点目标入组 96 人开始时间: 2019年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
96
主要终点
Acceptability: Is the intervention acceptable to the intended audience?

研究概览

简要总结

The aim of this study is to evaluate the feasibility of a new self-help intervention designed to support individuals (anyone with a cervix) to access cervical cancer screening following the experience of sexual assault, by addressing psychological barriers identified by previous research, specifically shame, low self-efficacy and the re-traumatising nature of attending to sexual health after sexual trauma.

详细描述

The study aims to investigate the acceptability, feasibility and limited efficacy of a discrete, easily accessed (mobile phone, tablet or computer) self-help intervention to support people to access cervical screening independently.

The study will use a wait-list control design, with participants randomly allocated to receive access to the intervention immediately or after a six-week wait.

The intervention will be in the form of a web app and will contain a range of psychoeducational material and practice exercises following a cognitive-behavioural and compassion-focused approach to understanding and coping with trauma, building self-compassion and increasing confidence in ability to attend and complete a screening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Has a cevix
  • Within age range for cervical cancer screening in UK (25-64 years)
  • Experience of sexual assault (in childhood and/or adulthood; not within last 12 months)
  • Currently experiencing difficulty attending cervical cancer screening
  • Has access to smartphone/computer with internet
  • Has a valid email address
  • Able to read and understand English
  • Living in UK

排除标准

  • No cervix
  • Outside of UK cervical cancer screening age range
  • No experience of sexual assault or sexual assault occurred within last 12 months
  • No access to smartphone or computer and internet
  • Unable to read or understand English
  • Not living in UK
  • In acute mental health crisis

研究组 & 干预措施

Self-help

Experimental

Immediate access to self-help materials

干预措施: Self-help (Other)

Control

No Intervention

Wait-list control - treatment as usual (no intervention)

结局指标

主要结局

Acceptability: Is the intervention acceptable to the intended audience?

时间窗: Six weeks

A series of statements written by the researchers asking for feedback on the intervention, including frequency of use, interest in the content, satisfaction. To be rated on a five-point scale (Completely agree - Completely disagree). This will be analysed descriptively (e.g. how many people would recommend the app to others having similar difficulties?)

Behavioural change - Does use of the intervention lead to an increase in bookings and attendance at screenings?

时间窗: Six weeks

Participants will be asked to report their progress at baseline and follow-up by answering a series of questions written by the researchers, for example 'I have contacted my GP surgery to ask them when cervical screening clinics take place' - Yes/No; 'I attended my cervical screening appointment' - Yes/No.

Behavioural change - Does use of the intervention facilitate completing a cervical screening? (i.e. does the intervention have limited efficacy?)

时间窗: Six weeks

Participants will be asked whether or not they have completed their cervical screening at baseline and follow-up. Answer options will be yes/no/appointment booked but hasn't happened yet

次要结局

  • Psychological change - Does use of the intervention lead to increased self-efficacy and self-compassion, and reduced shame?(Six weeks)
  • Psychological change - distress(Six weeks)

研究者

发起方
Royal Holloway University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Smallwood

Trainee Clinical Psychologist

Royal Holloway University

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