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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05717023
Study type Interventional
Source Royal Holloway University
Contact
Status Completed
Phase N/A
Start date February 17, 2023
Completion date May 16, 2023

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