Development and Evaluation of a Psychosocial Intervention for Nitrous Oxide Misuse in East London
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility drop out
研究概览
简要总结
Nitrous oxide (laughing gas, N₂O) is the third most commonly used recreational drug among young people in the UK. Although it may seem harmless, frequent use can damage the nerves and spinal cord. Vitamin B12 injections can help treat these neurological complications, but continued N₂O use can reduce how effective this treatment is.
Some people use N₂O to cope with stress or emotional difficulties, while others may find it hard to stop because of cravings or habits. These emotional and social difficulties can negatively affect recovery, wellbeing, and quality of life.
Our team has developed a new brief support programme for people experiencing mild to moderate emotional and social difficulties related to N₂O use. The programme provides information and practical strategies to help people cope, manage emotions, and prevent problems from worsening. It is delivered by a trained facilitator over up to four weekly sessions, either in-person or remotely.
In this study, the support programme will be introduced to patients attending the Royal London Hospital clinic for N₂O related neurological harms. Ten participants will receive the programme alongside their usual care. Participants will complete questionnaires before and after the programme to monitor mental health, quality of life, and dependence on N₂O. The research team will evaluate whether the programme was delivered as intended and whether participants remained engaged. Participants will be invited to take part in an interview to feedback on their experiences and suggest improvements before the programme is tested in a larger study. Participation will last up to 8 hours in total over approximately 9 weeks.
详细描述
Setting This is a feasibility study with nested qualitative interviews conducted by researchers based at Queen Mary University of London (QMUL) and Barts Health NHS Trust (BHNT). Participants are recruited from the N₂O SDEC pathway at the Royal London Hospital (RLH), BHNT.
Design Staged approach to intervention refinement and preliminary testing involving a mixed-methods feasibility and fidelity evaluation, with nested qualitative interviews.
Data Collection Methods Feasibility Evaluation All participants will complete an eligibility screen and provide informed consent before they enter the study. Details of the study will be explained via the Participant Information Sheet (PIS) ensuring that that the patient has sufficient time (at least 24 hours) to consider whether or not to participate. The Clinical Fellow will answer any questions that the patient has concerning study participation via telephone, videoconferencing, or email support. Those who wish to participate will be asked to complete a Consent Form.
Using Case Report Forms (CRF), recruitment figures will be calculated, including:
- Appropriateness of eligibility criteria - monitoring reasons for exclusion.
- Willingness of patients to take part - assessment of the size of the eligible population, refusal, and those that consent to participate.
- Determine success of recruitment strategy - monitoring numbers of patients with whom study was introduced, which research team members were involved, number of patients who expressed an interest in receiving PIS, and content of preliminary discussions/ questions with research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical neurological diagnosis related to N₂O use.
- •Experiencing mild to moderate psychological distress.
- •Aged 16-65 years.
- •Able to communicate in English.
- •Able and willing to give informed consent.
排除标准
- •Other causes of neurological symptoms.
- •Currently receiving another structured psychosocial intervention.
- •Severe psychiatric distress.
结局指标
主要结局
Feasibility drop out
时间窗: 12 months
Drop outs and completion
Feasibility response rate
时间窗: 12 months
Response rates
Feasibility uptake
时间窗: 12 months
Study uptake
次要结局
- Fidelity accuracy(12 months)
- Fidelity quality(12 months)
- Acceptability(12 months)