Clinical trial NCT04104724: CFT Self-Help for Accessing Cervical Screening After Sexual Assault
Official title: A Feasibility Study of a Compassion-focused Self-help Intervention Designed to Increase Access to Cervical Screening Following Sexual Assault
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Psychological
Sexual Violence
Cervical Cancer
Lead sponsor: Royal Holloway University
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
First posted: 2019-09-26
Enrollment: 96
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability: Is the intervention acceptable to the intended audience?
timeFrame: Six weeks
measure: Behavioural change - Does use of the intervention lead to an increase in bookings and attendance at screenings?
timeFrame: Six weeks
measure: Behavioural change - Does use of the intervention facilitate completing a cervical screening? (i.e. does the intervention have limited efficacy?)
timeFrame: Six weeks
Secondary outcomes:
measure: Psychological change - Does use of the intervention lead to increased self-efficacy and self-compassion, and reduced shame?
timeFrame: Six weeks
measure: Psychological change - distress
timeFrame: Six weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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. doi: 10.1097/01.MLR.0000093487.78664.3C.
citation: 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.
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.
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.
citation: Bandura, A. (2006). Guide for constructing self-efficacy scales. Self-efficacy Beliefs of Adolescents, 5(1), 307-337.
citation: 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.