Randomised Controlled Trial (RCT) to Assess the Feasibility, Acceptability and Preliminary Effectiveness of Group Emotion-focused Therapy (EFT) Intervention for Transdiagnostic Eating Disorders/Difficulties in Student Counselling Services.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The Eating Disorder Examination Questionnaire (EDE-Q)
研究概览
简要总结
What is the purpose of the study? Emotion-Focused Therapy (EFT) is a therapeutic approach that helps individuals identify, explore, and transform difficult emotions to improve emotional wellbeing and resolve psychological issues. While there is a growing body of evidence for the effectiveness of both individual and group EFT with a range of difficulties, including eating disorders, this has not yet been sufficiently explored within university counselling services. The purpose of this study is to assess the feasibility, acceptability, and preliminary effectiveness of a group EFT intervention for students experiencing eating disorders or concerns related to eating, weight, and shape. The study aims to determine whether this type of therapy can be effectively delivered within a university counselling service, and if it could potentially improve participants' mental health and wellbeing.
详细描述
Who is being asked to participate? You are invited to participate if you: are experiencing an eating disorder or have eating, weight and shape concerns, have a body mass index greater than 15kg/m2 and have sufficient English for talking therapy. You will be ineligible to take part if you: are participating in psychological one-to-one or group therapy at the same time as attending the intervention group, have considerable psychological risk, including active suicidal plans, are experiencing psychosis, have an alcohol or substance use issue, pose a risk of harm towards others, are pregnant, or have a diagnosed intellectual disability that impairs your ability to access therapy.
Do I have to take part? Your participation in this study is entirely voluntary. If you agree to take part, I will then ask you to complete a consent form. You are free to withdraw at any time, without giving a reason.
Randomised Controlled Trial (RCT) The study will use an RCT design, meaning that, if you sign up for the study, you will be randomly assigned either to partake in the group EFT intervention, or to not partake in this. Regardless of the group to which you are assigned, you will be asked to complete sets of questionnaires at the beginning and end of the study. This will allow us to compare questionnaire data for those who received the intervention and those who did not, to gain an initial indication of whether the intervention is helpful or not. Your engagement is therefore of significant value to us regardless of whether you take part in the intervention during the study period.
What will happen to me if I take part? You will first undergo a screening process to ensure that you meet the eligibility criteria. If you are eligible, you will be randomly assigned to either the intervention group, which will participate in the EFT group therapy, or to the control group, who will not participate in the EFT group therapy. . There is an equal chance of being put into either group. Both groups will be asked to complete a set of questionnaires before and after the intervention period, regardless of group assignment. The questionnaires will measure eating disorder symptoms, psychosocial impairment, self-criticism, depression and anxiety. The intervention is a 10 to 12-week closed therapy group for students seeking support regarding issues related to eating, weight and shape concerns. Group members will be facilitated to recognise and explore some of the difficult emotions underlying these issues. In particular, the group will focus on 'taming' the inner critic, that part of ourselves that criticises or chastises us for not being good enough. By identifying the critic in ourselves and by witnessing it in others, group members may be better positioned to figure out what they really need from themselves at times of difficulty. There will be some information provided around eating and emotions, with the focus of the sessions being on experiential exercises under the guidance of the group facilitators.
What are the possible disadvantages and risks of taking part? Participation in this study will involve reflecting on and talking about difficult and sensitive topics related to your eating, weight and shape concerns and self-criticism. This can sometimes lead to emotional distress. To ensure everyone feels supported, the group therapy sessions will be facilitated by experienced therapists who are trained in handling emotional distress. If you feel overwhelmed at any point, you are encouraged to communicate with the group facilitators, who can provide support and refer you to additional resources if required. Group participants are required to be respectful of other participants' concerns and difficulties and confidentiality is of paramount importance to ensure a safe environment for sharing. If you are in the control group and feel overwhelmed, you are encouraged to speak with the Student Counselling and Wellbeing Service staff involved in your support, who will be able to respond to your concerns and refer you to additional resources if required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open referral with the counselling/student support service, meaning students can engage in a screening appointment with a group facilitator
- •Global EDE-Q Score ≥ 2.77 (cutoff for disordered eating in the general population as per EDE-Q norms attached).
- •or Score ≥ Mean + 1 SD on at least one EDE-Q subscale (Restraint, Eating Concern, Shape Concern, or Weight Concern)
- •Have body mass index (BMI) greater than 15kg/m2
- •Have sufficient English for talking therapy
- •Over the age of 18
排除标准
- •Considerable psychological risk, including active suicidal plans
- •Comorbidity taking priority
- •Alcohol/substance use disorder
- •Risk of harm towards others
- •Participating in concurrent psychological one-to-one or group treatment
- •Diagnosed intellectual disability impeding ability to access therapy
结局指标
主要结局
The Eating Disorder Examination Questionnaire (EDE-Q)
时间窗: From baseline prior to the intervention/control condition beginning to post-intervention (2-4 weeks post-intervention)
A 28-item self-report questionnaire, measuring the range, frequency and severity of behaviours associated with a diagnosis of an ED. It is categorised into 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and an overall global score, with a higher score indicating more problematic eating difficulties. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale. To obtain an overall or 'global' score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e. four). Subscale scores are reported as means and standard deviations. Likert scale ranges from 0 to 6, therefore minimum score is 0 and maximum score is 6.
次要结局
- The Clinical Impairment Assessment Questionnaire (CIA)(From baseline prior to the intervention/control condition beginning to post-intervention (2-4 weeks post-intervention))
- The Forms of Self-Criticism/Attacking & Self-Reassuring Scale (FSCRS)(From baseline prior to the intervention/control condition beginning to post-intervention (2-4 weeks post-intervention))
- Depression Anxiety Stress Scales-Short Form (DASS-21)(From baseline prior to the intervention/control condition beginning to post-intervention (2-4 weeks post-intervention))
- Counseling Center Assessment of Psychological Symptoms (CCAPS) 34(From baseline prior to the intervention/control condition beginning to post-intervention (2-4 weeks post-intervention))
- Difficulties in Emotion Regulation Scale (DERS)(From baseline prior to the intervention/control condition beginning to post-intervention (2-4 weeks post-intervention))
- Bespoke questionnaire to measure the acceptability of the intervention(From baseline prior to the intervention/control condition beginning to post-intervention (2-4 weeks post-intervention))