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Guided Self-help Following Sexual Assault - SCED

Primary Purpose

Sexual Assault, Sexual Dysfunction, Sex Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online guided self-help intervention for sexual distress following sexual assault
Sponsored by
Royal Holloway University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Assault focused on measuring sexual distress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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).

Sites / Locations

  • Bart's Sexual Wellbeing Service, National Health Service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Baseline Visual Analogue Scales
Visual analogue scales are scales with two ends. Participants will be asked to rate on the line how much they agree or disagree with a statement. Visual analogue scales are used to measure the following concepts: shame, guilt, self-criticism, compassion, normalising and motivation. The scales were developed for this research project in collaboration with experts by experience.
Intervention Visual Analogue Scales
Visual analogue scales are scales with two ends. Participants will be asked to rate on the line how much they agree or disagree with a statement. Visual analogue scales are used to measure the following concepts: shame, guilt, self-criticism, compassion, normalising and motivation. The scales were developed for this research project in collaboration with experts by experience.
Female Sexual Distress scale - Revised (FSDS-R)
The Female Sexual Distress Scale - Revised is used to assess distress related to sex in women. This 13-item self-report questionnaire is scored has five points, (0: never; 1: rarely; 2: occasionally; 3: frequently; 4: always). Total scores range from 0 to 52 with higher scores indicating higher levels of sexual distress.
Female Sexual Function Index (FSFI)
The Female Sexual Function Index is a 19-item questionnaire that measures six domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The questionnaire uses a 5-point likert scale and is scored from 1 to 5. Total score range from 2 to 36 with lower scores indicating higher levels of difficulties.
State Self Compassion Questionnaire (SSCS-S)
The State Self Compassion Questionnaire is a 6-item questionnaire scored on a 5-point scale from 1 (not very true for me) to 5 (very true for me). The scale was not develop to indicate high or low levels of state self-compassion rather it is to be used in a comparative manner to examine the change in compassion after the intervention. The minimum score is 1 and the maximum score is 5.

Full Information

First Posted
January 17, 2023
Last Updated
May 16, 2023
Sponsor
Royal Holloway University
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT05717023
Brief Title
Guided Self-help Following Sexual Assault - SCED
Official Title
Online Guided Self-help Intervention for Sexual Distress Following Sexual Assault: A Single Case Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Holloway University
Collaborators
National Health Service, United Kingdom

4. Oversight

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

5. Study Description

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.
Detailed Description
The study adopts a non-concurrent AB single-case experimental design (SCED) with follow-up. Although AB designs are not sufficient to test treatment effectiveness, using this study type informs the feasibility of the intervention. In addition, a multiple baseline approach was adopted where participants will be randomly allocated to different lengths of baselines ranging from 5 to 14 days in Phase A. Phase B consists of a 4- week intervention period where participants complete idiographic measures daily. Follow-up will be completed one month after the intervention. Potential participants will complete an online screening questionnaire via Qualtrics. Eligible participants who provide consent will complete the baseline questionnaires such as the Female Sexual Function Index, Female Sexual Distress Scale and State Self Compassion Scale. Afterwards, participants will be randomly allocated to different baseline lengths (5 to 14 days) for Phase A. Participants complete visual analogue scales daily for the length of Phase A. Following Phase A, participants begin Phase B, completing the intervention weekly for four weeks. Visual analogue scales are completed daily during phase B. Follow-up occurs four weeks after Phase B. Participants complete the Female Sexual Function Index, Female Sexual Distress Scale, State Self Compassion Scale, Client Satisfaction Questionnaire and a qualitative feedback form.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Assault, Sexual Dysfunction, Sex Disorder
Keywords
sexual distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single case experimental design
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online guided self-help intervention for sexual distress following sexual assault
Arm Type
Experimental
Arm Description
The intervention only has one arm. All participants will be provided 4 sessions of guided self-help intervention to be completed once weekly.
Intervention Type
Behavioral
Intervention Name(s)
Online guided self-help intervention for sexual distress following sexual assault
Intervention Description
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.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
At follow up, 8 weeks
Title
Feedback Form
Description
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.
Time Frame
At follow up, 8 weeks
Secondary Outcome Measure Information:
Title
Baseline Visual Analogue Scales
Description
Visual analogue scales are scales with two ends. Participants will be asked to rate on the line how much they agree or disagree with a statement. Visual analogue scales are used to measure the following concepts: shame, guilt, self-criticism, compassion, normalising and motivation. The scales were developed for this research project in collaboration with experts by experience.
Time Frame
Completed daily up to 2 weeks
Title
Intervention Visual Analogue Scales
Description
Visual analogue scales are scales with two ends. Participants will be asked to rate on the line how much they agree or disagree with a statement. Visual analogue scales are used to measure the following concepts: shame, guilt, self-criticism, compassion, normalising and motivation. The scales were developed for this research project in collaboration with experts by experience.
Time Frame
Completed daily up to 1 month
Title
Female Sexual Distress scale - Revised (FSDS-R)
Description
The Female Sexual Distress Scale - Revised is used to assess distress related to sex in women. This 13-item self-report questionnaire is scored has five points, (0: never; 1: rarely; 2: occasionally; 3: frequently; 4: always). Total scores range from 0 to 52 with higher scores indicating higher levels of sexual distress.
Time Frame
Baseline and 8 weeks
Title
Female Sexual Function Index (FSFI)
Description
The Female Sexual Function Index is a 19-item questionnaire that measures six domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The questionnaire uses a 5-point likert scale and is scored from 1 to 5. Total score range from 2 to 36 with lower scores indicating higher levels of difficulties.
Time Frame
Baseline and 8 weeks
Title
State Self Compassion Questionnaire (SSCS-S)
Description
The State Self Compassion Questionnaire is a 6-item questionnaire scored on a 5-point scale from 1 (not very true for me) to 5 (very true for me). The scale was not develop to indicate high or low levels of state self-compassion rather it is to be used in a comparative manner to examine the change in compassion after the intervention. The minimum score is 1 and the maximum score is 5.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cis female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Vosper
Organizational Affiliation
Bart's NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bart's Sexual Wellbeing Service, National Health Service
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Guided Self-help Following Sexual Assault - SCED

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