Trauma, Psychological, Sexual Violence, Cervical Cancer
Conditions
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.
Interventions
OTHERSelf-help
self-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re. attending cervical cancer screening
Sponsors
Barts & The London NHS Trust
Royal Holloway University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed