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Clinical Trials/NCT04104724
NCT04104724
Unknown
N/A

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

Royal Holloway University0 sites96 target enrollmentOctober 20, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Trauma, Psychological
Sponsor
Royal Holloway University
Enrollment
96
Primary Endpoint
Acceptability: Is the intervention acceptable to the intended audience?
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2019
End Date
May 3, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Royal Holloway University
Responsible Party
Principal Investigator
Principal Investigator

Jane Smallwood

Trainee Clinical Psychologist

Royal Holloway University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Acceptability: Is the intervention acceptable to the intended audience?

Time Frame: 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?

Time Frame: 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?)

Time Frame: 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

Secondary Outcomes

  • 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)

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