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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer; Sexual Violence; Trauma, Psychological
• Intervention / Treatment: Other: Self-help

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: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-help; Immediate access to self-help materials	Other: Self-help; self-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re. attending cervical cancer screening; Other Names: psychoeducation; compassion-focused therapy; cognitive behaviour therapy
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?	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?	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?)	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?	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	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: Royal Holloway University
• Collaborators: Barts & The London NHS Trust

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

• My Body Back Project

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2019
• Primary Completion (Anticipated): May 3, 2020
• Study Completion (Anticipated): May 3, 2020

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Psychological Trauma
• Other Study ID Numbers: JSmallwoodDClinPsy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No