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CFT Self-Help for Accessing Cervical Screening After Sexual Assault

Primary Purpose

Trauma, Psychological, Sexual Violence, Cervical Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-help
Sponsored by
Royal Holloway University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trauma, Psychological

Eligibility Criteria

25 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Self-help

    Control

    Arm Description

    Immediate access to self-help materials

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

    Outcomes

    Primary Outcome Measures

    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?)
    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.
    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

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    September 26, 2019
    Sponsor
    Royal Holloway University
    Collaborators
    Barts & The London NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04104724
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2019 (Anticipated)
    Primary Completion Date
    May 3, 2020 (Anticipated)
    Study Completion Date
    May 3, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Royal Holloway University
    Collaborators
    Barts & The London NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trauma, Psychological, Sexual Violence, Cervical Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Self-help
    Arm Type
    Experimental
    Arm Description
    Immediate access to self-help materials
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Wait-list control - treatment as usual (no intervention)
    Intervention Type
    Other
    Intervention Name(s)
    Self-help
    Other Intervention Name(s)
    compassion-focused therapy, cognitive behaviour therapy, psychoeducation
    Intervention Description
    self-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re. attending cervical cancer screening
    Primary Outcome Measure Information:
    Title
    Acceptability: Is the intervention acceptable to the intended audience?
    Description
    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?)
    Time Frame
    Six weeks
    Title
    Behavioural change - Does use of the intervention lead to an increase in bookings and attendance at screenings?
    Description
    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.
    Time Frame
    Six weeks
    Title
    Behavioural change - Does use of the intervention facilitate completing a cervical screening? (i.e. does the intervention have limited efficacy?)
    Description
    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
    Time Frame
    Six weeks
    Secondary Outcome Measure Information:
    Title
    Psychological change - Does use of the intervention lead to increased self-efficacy and self-compassion, and reduced shame?
    Description
    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.
    Time Frame
    Six weeks
    Title
    Psychological change - distress
    Description
    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.
    Time Frame
    Six weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11931676
    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.
    Results Reference
    background
    PubMed Identifier
    14583691
    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.
    Results Reference
    background
    PubMed Identifier
    17339617
    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.
    Results Reference
    background
    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.
    Results Reference
    background
    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.
    Results Reference
    background
    Citation
    Bandura, A. (2006). Guide for constructing self-efficacy scales. Self-efficacy Beliefs of Adolescents, 5(1), 307-337.
    Results Reference
    background
    PubMed Identifier
    23027982
    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.
    Results Reference
    background
    Links:
    URL
    http://mybodybackproject.com
    Description
    My Body Back Project

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    CFT Self-Help for Accessing Cervical Screening After Sexual Assault

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