Online Guided Self-help Intervention for Sexual Distress Following Sexual Assault: A Single Case Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire (CSQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Client Satisfaction Questionnaire (CSQ)
时间窗: At follow up, 8 weeks
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
时间窗: At follow up, 8 weeks
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.
次要结局
- Baseline Visual Analogue Scales(Completed daily up to 2 weeks)
- Female Sexual Function Index (FSFI)(Baseline and 8 weeks)
- State Self Compassion Questionnaire (SSCS-S)(Baseline and 8 weeks)
- Female Sexual Distress scale - Revised (FSDS-R)(Baseline and 8 weeks)
- Intervention Visual Analogue Scales(Completed daily up to 1 month)
研究者
Kimberley Khoo
Principal Investigator, Trainee Clinical Psychologist
Royal Holloway University