CFT Self-Help for Accessing Cervical Screening After Sexual Assault

NCT ID: NCT04104724

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-20

Study Completion Date

2020-05-03

Brief Summary

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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

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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

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Trauma, Psychological Sexual Violence Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Self-help

Immediate access to self-help materials

Group Type EXPERIMENTAL

Self-help

Intervention Type OTHER

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-help

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

Intervention Type OTHER

Other Intervention Names

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compassion-focused therapy cognitive behaviour therapy psychoeducation

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role collaborator

Royal Holloway University

OTHER

Sponsor Role lead

Responsible Party

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Jane Smallwood

Trainee Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 11931676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14583691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17339617 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 23027982 (View on PubMed)

Related Links

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http://mybodybackproject.com

My Body Back Project

Other Identifiers

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JSmallwoodDClinPsy

Identifier Type: -

Identifier Source: org_study_id