Trauma, PsychologicalNCT04104724

CFT Self-Help for Accessing Cervical Screening After Sexual Assault

A study testing Self-help in people with Trauma, Psychological and Sexual Violence, run by Royal Holloway University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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… Read more about this study

Who is it for?: Ages 25 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for: Trauma, Psychological, Sexual Violence, Cervical Cancer
What is being tested?: Self-help
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: No sites listed yet
Study dates: 20 Oct 2019to 3 May 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 64 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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.

Conditions: Trauma, Psychological, Sexual Violence, Cervical Cancer
Being tested: Self-help
Medical subject headings: Psychological Trauma, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-helpOther
Also called compassion-focused therapy, cognitive behaviour therapy, psychoeducation
self-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re. attending cervical cancer screening

Study groups in NCT04104724
Study group	Role	What they receive
Self-help	Experimental	Immediate access to self-help materials Receives: Other: Self-help
Control	No intervention	Wait-list control - treatment as usual (no intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

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?)
Measured: 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.
Measured: 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
Measured: Six weeks

Secondary outcomes (2)

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.
Measured: Six weeks
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.
Measured: Six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 20193 May 2020

First posted26 Sep 2019
Study start20 Oct 2019 (estimated)
Primary completion3 May 2020 (estimated)
Study completion3 May 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04104724
Sponsor's protocol ID: JSmallwoodDClinPsy
Status last verified: Sep 2019
First submitted: 24 Sep 2019
Last updated: 30 Sep 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 11931676
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.
PubMed 14583691
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.
PubMed 17339617
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.
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.
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.
PubMed 23027982

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of a Compassion-focused Self-help Intervention Designed to Increase Access to Cervical Screening Following Sexual Assault
ClinicalTrials.gov ID: NCT04104724
Acronym / sponsor ID: JSmallwoodDClinPsy
Conditions: Trauma, Psychological, Sexual Violence, Cervical Cancer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 96 participants (estimated)
Lead sponsor: Royal Holloway UniversityUniversity, hospital or other
Collaborators: Barts & The London NHS Trust
Study start: 20 Oct 2019 (estimated)
Primary completion: 3 May 2020 (estimated)
Study completion: 3 May 2020 (estimated)
First posted: 26 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Self-help	Experimental	Other: Self-helpImmediate access to self-help materials
Control	No intervention	–Wait-list control - treatment as usual (no intervention)

Who may qualify

Ages: 25 to 64 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Self-helpAlso: compassion-focused therapy, cognitive behaviour therapy, psychoeducationself-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re. attending cervical cancer screening	Other	Self-help

Primary outcome

Acceptability: Is the intervention acceptable to the intended audience?
Time frame: Six weeks
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?
Time frame: Six weeks
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?)
Time frame: Six weeks
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

2 secondary outcomes

Psychological change - Does use of the intervention lead to increased self-efficacy and self-compassion, and reduced shame?
Time frame: Six weeks
Psychological change - distress
Time frame: Six weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Background: PubMed 11931676Andrews 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.
Background: PubMed 14583691Kroenke 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.
Background: PubMed 17339617Kroenke 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.
BackgroundWeathers, 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.
BackgroundGilbert, 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.
BackgroundBandura, A. (2006). Guide for constructing self-efficacy scales. Self-efficacy Beliefs of Adolescents, 5(1), 307-337.
Background: PubMed 23027982Cadman 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.
My Body Back ProjectLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Self-help in people with Trauma, Psychological and Sexual Violence, run by Royal Holloway University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability: Is the intervention acceptable to the intended audience? (time frame: Six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04104724, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.