Clinical trial NCT05717023: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Sexual Dysfunction
Sex Disorder
Keywords: sexual distress
Lead sponsor: Royal Holloway University
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2023-02-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single case experimental design
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: At follow up, 8 weeks
measure: Feedback Form
timeFrame: At follow up, 8 weeks
Secondary outcomes:
measure: Baseline Visual Analogue Scales
timeFrame: Completed daily up to 2 weeks
measure: Intervention Visual Analogue Scales
timeFrame: Completed daily up to 1 month
measure: Female Sexual Distress scale - Revised (FSDS-R)
timeFrame: Baseline and 8 weeks
measure: Female Sexual Function Index (FSFI)
timeFrame: Baseline and 8 weeks
measure: State Self Compassion Questionnaire (SSCS-S)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Bart's Sexual Wellbeing Service, National Health Service
Study officials:
affiliation: Bart's NHS Foundation Trust
name: Jane Vosper
role: PRINCIPAL_INVESTIGATOR
References: