CFT Self-Help for Accessing Cervical Screening After Sexual Assault

Not Applicable

• Conditions: Sexual Violence; Trauma, Psychological; Cervical Cancer
• Interventions: Other: Self-help

• Registration Number: NCT04104724
• Lead Sponsor: Royal Holloway University

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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-30
• Study Start: 2019-10-20
• Primary Completion: 2020-05-03
• Study Completion: 2020-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-help	Self-help	Immediate access to self-help materials

Primary Outcome Measures

Name	Time	Method
Acceptability: Is the intervention acceptable to the intended audience?	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?	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?)	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 Outcome Measures

Name	Time	Method
Psychological change - Does use of the intervention lead to increased self-efficacy and self-compassion, and reduced shame?	Six weeks	Experience of Shame Scale - Items scored from 1-4 (not at all - very much); higher scores indicate higher levels of shame. Total score ranges from 25-100; can also be broken down into subscales: characterological (range 12-48), behavioural (range 9-36) and bodily (range 4-16) shame.; The Compassionate Engagement and Action Scale - Self-Compassion subscales. All items scored on a scale of 1-10 (Never-Always), total scores range from 10-100 with a higher score indicating greater self-compassion.; Self-efficacy scale - questions to assess self-efficacy specifically relating to ability to attend a cervical screening (e.g. 'I can contact my GP surgery to book a cervical screening') - to be rated on a scale of 0 (cannot do at all) to 100 (highly certain can do), leading to an overall total ranging from 0 to 1200; higher scores suggest greater self-efficacy.
Psychological change - distress	Six weeks	Additional clinical outcome measures will be the PCL-5, measuring PTSD symptomatology; the PHQ-2, measuring low mood and the GAD-2, measuring anxiety. On each of these measures higher scores suggest more distress.; Items on the PCL-5 are scored from 0 (not at all) to 4 (extremely) with a possible total range from 0 to 80. The PHQ-2 and GAD-2 each comprise two items scored from 0 (not at all) to 3 (nearly every day) with possible total scores ranging from 0 to 6.