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
About this trial
This is an interventional prevention trial for Trauma, Psychological
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
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
NCT ID
NCT04104724
First Posted
September 24, 2019
Last Updated
September 26, 2019
Sponsor
Royal Holloway University
Collaborators
Barts & The London NHS Trust
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
Learn more about this trial
CFT Self-Help for Accessing Cervical Screening After Sexual Assault
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