CFT Self-Help for Accessing Cervical Screening After Sexual Assault
A Feasibility Study of a Compassion-focused Self-help Intervention Designed to Increase Access to Cervical Screening Following Sexual Assault
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-help
Immediate access to self-help materials
|
self-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re.
attending cervical cancer screening
Other Names:
|
|
No Intervention: Control
Wait-list control - treatment as usual (no intervention)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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?)
|
Six weeks
|
|
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.
|
Six weeks
|
|
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
|
Six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological change - Does use of the intervention lead to increased self-efficacy and self-compassion, and reduced shame?
Time Frame: 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. |
Six weeks
|
|
Psychological change - distress
Time Frame: 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. |
Six weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
- Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
- Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
- Andrews B, Qian M, Valentine JD. Predicting depressive symptoms with a new measure of shame: The Experience of Shame Scale. Br J Clin Psychol. 2002 Mar;41(Pt 1):29-42. doi: 10.1348/014466502163778.
- Gilbert, P., Catarino, F., Duarte, C., Matos, M., Kolts, R., Stubbs, J., ... & Basran, J. (2017). The development of compassionate engagement and action scales for self and others. Journal of Compassionate Health Care, 4(1), 4.
- Bandura, A. (2006). Guide for constructing self-efficacy scales. Self-efficacy Beliefs of Adolescents, 5(1), 307-337.
- Cadman L, Waller J, Ashdown-Barr L, Szarewski A. Barriers to cervical screening in women who have experienced sexual abuse: an exploratory study. J Fam Plann Reprod Health Care. 2012 Oct;38(4):214-20. doi: 10.1136/jfprhc-2012-100378.
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSmallwoodDClinPsy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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