CFT Self-Help for Accessing Cervical Screening After Sexual Assault

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04104724
• Other study ID #: JSmallwoodDClinPsy
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2019
• Est. completion date: May 3, 2020

Study information

• Verified date: September 2019
• Source: Royal Holloway University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: May 3, 2020
• Est. primary completion date: May 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Psychological Trauma
• Sexual Violence
• Trauma, Psychological

Intervention

Other:
• Self-help
self-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re. attending cervical cancer screening

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Royal Holloway University	Barts & The London NHS Trust

References & Publications (7)

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. — View Citation

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. — View Citation

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.

Kroenke K, Spitzer RL, Williams JB, Monahan PO, Löwe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

•   My Body Back Project