NCT05717023

Brief Summary

This single-case experimental design aims to evaluate the acceptability \& feasibility of an online guided self-help intervention for female survivors of sexual assault who experience difficulties returning to sex. The main questions it aims to answer are: • Is the intervention viewed as acceptable by female survivors of sexual assault? Acceptability is defined as as how willing participants are to use the materials and their satisfaction with its content. The secondary question is, are there initial indicators that the intervention is effective? Effectiveness is measured by a reduction in the measure of sexual distress and improvement of sexual satisfaction - specifically confidence and motivation in practising strategies that will improve their experience of sex. Participants will complete the intervention independently. There will be 4-sessions which involve watching videos, with one session completed weekly. The developed materials aim to to help women understand their difficulties, learn practical strategies and build confidence in returning to sex. The materials are also guided by a piloted group for sexual distress by Bart's National Health Service (NHS) trust Sexual Wellbeing Service. The NHS is the publicly funded healthcare system in England.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

January 17, 2023

Last Update Submit

May 16, 2023

Conditions

Sexual AssaultSexual DysfunctionSex Disorder

Keywords

sexual distress

Outcome Measures

Primary Outcomes (2)

  • Client Satisfaction Questionnaire (CSQ)

    The client satisfaction questionnaire is an 8-item questionnaire scored on a 4-point scale and will be provided to participants at follow up to ask the acceptability and satisfaction towards the intervention. Permission has been asked to adapt the questionnaire to focus on satisfaction for the intervention instead of service satisfaction. Total scores range from 8 to 32 with higher scores indicating higher satisfaction.

    At follow up, 8 weeks

  • Feedback Form

    A short qualitative feedback form will be provided to participants. This form has been developed with experts by experience and will have open ended questions for participants to provide more detailed feedback about the intervention. The questionnaire is only used at follow up.

    At follow up, 8 weeks

Secondary Outcomes (5)

  • Baseline Visual Analogue Scales

    Completed daily up to 2 weeks

  • Intervention Visual Analogue Scales

    Completed daily up to 1 month

  • Female Sexual Distress scale - Revised (FSDS-R)

    Baseline and 8 weeks

  • Female Sexual Function Index (FSFI)

    Baseline and 8 weeks

  • State Self Compassion Questionnaire (SSCS-S)

    Baseline and 8 weeks

Study Arms (1)

Online guided self-help intervention for sexual distress following sexual assault

EXPERIMENTAL

The intervention only has one arm. All participants will be provided 4 sessions of guided self-help intervention to be completed once weekly.

Behavioral: Online guided self-help intervention for sexual distress following sexual assault

Interventions

Online guided self-help intervention for sexual distress following sexual assaultBEHAVIORAL

4 Sessions of guided self-help will be shared with the participants. These will be in the form of handout and video recordings that participant access through Qualtrics. The intervention is based on research on sexual trauma, psychosexual difficulties and materials developed by Bart's NHS Foundation Trust Sexual Wellbeing Service. It has been made in collaboration with clinicians within the service, experts by experience and the chief investigator.Within the document there are scripts for each session which are read out in the video recordings. The handouts depict the visual images for the video and the materials provided to participant.

Online guided self-help intervention for sexual distress following sexual assault

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCis female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cis female
  • Experience of sexual assault (in adulthood or childhood but not within the previous 12 months)
  • Experiencing sexual distress/difficulties
  • United Kingdom Resident
  • Willingness to complete guided self help
  • Aged 18 and above
  • Ability to read and understand English to provide informed consent and meaningfully engage with the self-help materials
  • Ability to access online guided self-help material through a computer or phone

You may not qualify if:

  • experiencing severe acute mental health difficulties
  • sexual assault occurring within the last 12 months
  • currently experiencing more than fleeting suicidal thoughts or engaging in severe self-harming (individuals who have been sexually assaulted are likely to experience suicidal thoughts or self harm behaviours, individuals with fleeting suicidal thoughts or superficial self harm with strong protective factors may be included however, since there is no contact with mental health professionals during the intervention unless participants reach out for triage, it is difficult to assess risk and participants have to be excluded if they do not have social support systems of are currently accessing psychological support).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bart's Sexual Wellbeing Service, National Health Service

London, United Kingdom

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jane Vosper

    Bart's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single case experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Trainee Clinical Psychologist

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 8, 2023

Study Start

February 17, 2023

Primary Completion

April 21, 2023

Study Completion

May 16, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)