CFT Self-Help for Accessing Cervical Screening After Sexual Assault

NCT04104724 | Unknown

• 1 other identifier: JSmallwoodDClinPsy
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trauma, Psychological; Sexual Violence; Cervical Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Psychological change - Does use of the intervention lead to increased self-efficacy and self-compassion, and reduced shame?

  Six weeks

• Psychological change - distress

  Six weeks

Study Arms (2)

Self-help

EXPERIMENTAL

Immediate access to self-help materials

Other: Self-help

Control

NO INTERVENTION

Wait-list control - treatment as usual (no intervention)

Interventions

Self-help OTHER

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

Also known as: compassion-focused therapy, cognitive behaviour therapy, psychoeducation

Self-help

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Holloway University: lead
• Barts & The London NHS Trust: collaborator

Related 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. doi: 10.1348/014466502163778.

  PMID: 11931676 BACKGROUND

• 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.

  PMID: 14583691 BACKGROUND

• 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.

  PMID: 17339617 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Bandura, A. (2006). Guide for constructing self-efficacy scales. Self-efficacy Beliefs of Adolescents, 5(1), 307-337.

  BACKGROUND

• 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.

  PMID: 23027982 BACKGROUND

Related Links

• My Body Back Project

MeSH Terms

Conditions

Psychological Trauma; Uterine Cervical Neoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: October 20, 2019
• Primary Completion: May 3, 2020
• Study Completion: May 3, 2020
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share