Feasibility and Acceptability of Single-Session Method of Levels Psychotherapy Within Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Clinical Outcomes in Routine Evaluation-Outcome Measure
研究概览
简要总结
People sometimes wait a long time for psychological therapy and could have this sooner if they had only one session. This is because they may only require one session to meet their needs if this is provided quickly (Cannistrà et al., 2020) and may therefore require less therapy overall, and if they can access this, then services can run more efficiently, and overall capacity of services to offer therapy can increase.
Some therapies are hard to deliver in one session. But the method of levels (MOL) was conceived to be highly flexible with respect to session length and number of sessions, and this makes it easier to use in one-off sessions. It is designed to help people focus on problems they describe as being most relevant to them and to find their own solutions.
We want to know if we can give one session of MOL to people seeking help from their GP. We want to see if they find it helpful. So we need to find out if they want and attend the session and if they tell us about it.
This will help us decide whether to run a larger study exploring whether one session of MOL can help meet the goals of people seeking GP support. This could tell us whether MOL could help reduce waiting times.
We will ask people using GP surgeries if they want to participate. They will be offered one session of MOL with their usual support. We will ask them to complete questionnaires to see if they found the therapy helpful.
We will note how many participate, attend sessions, and complete questionnaires. We will check whether participants liked having MOL and will interview 10-12 of them to learn about what they thought.
The research will be funded by The University of Manchester.
详细描述
DESIGN This mixed-methods, randomised, controlled, single-arm acceptability and feasibility pilot trial study will use a within-subjects design featuring an experimental group (receiving one session of MOL alongside usual treatment) and no control group. The study will contain a qualitative element through the analysis of qualitative questionnaire and interview feedback.
The study's contingency plan involves adopting a case series methodology featuring a smaller number of participants (all of whom would be interviewed).
RECRUITMENT One group of participants will be recruited: service users of a GP surgery who will be offered one session of MOL. We intend to have 5 participating GP practices recruited for the study, and the plan is to recruit 25 patients. Of these, a further intention is to recruit 10 to 12 participants to attend an interview about their experiences of their session. The overall recruitment target is 25 participants across the 5 participating GP surgeries.
The contingency plan would involve recruiting a smaller number of participants, all of whom would be interviewed.
PROCEDURE Potential participants registered at a Manchester GP surgery will be asked if they would like to take part in the study. This will be through a verbal question from their GP, a letter sent to them by the practice manager, a poster, or a text from the GP surgery. Potential participants who express interest in taking part (by informing the surgery or their GP or by signing and submitting the consent to contact form on the website whose URL will be texted to them) will have an information sheet passed to them, and their contact details will be shared (by their GP if they express interest to their GP) with the trainee clinical psychologist.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will:
- •Be able to speak and read English as a first language
- •Be registered at a participating GP surgery and be due to remain at the surgery until the study's completion
- •Provide informed consent to participate in the study
- •Be 18 years of age or older
- •Be able to complete outcome measures
- •Score above 10 on an initial core outcome measure
- •Express that they are having a difficulty with which they would like help.
排除标准
- •Participants will not:
- •Have a mental health difficulty with a confirmed and known organic or neurological foundation
- •Be under drug and alcohol services for a substance misuse problem
- •Be experiencing active psychosis
- •Be under secondary care services for a mental health difficulty
- •Express that they have had plans or intentions to end their life or to harm themselves over the month before recruitment
- •Express that they have attempted to harm themselves in the month before recruitment
- •Express that they have attempted to end their life in the year before recruitment
- •Be unable to travel to their GP surgery for their session.
- •Individuals who do not meet the study's inclusion criteria will be unable to participate in the research.
- •It is worth clarifying the reason that participants must be able to speak English as a first language. MOL involves the therapist asking their interlocutor to articulate their thoughts in the present moment. This could entail participants being interrupted in order that the therapist can ask about background thoughts that may be pertinent to the difficulty being discussed. The presence of English as a first language as an inclusion criterion is a way of ensuring sufficient English language skills for this process to take place.
结局指标
主要结局
Clinical Outcomes in Routine Evaluation-Outcome Measure
时间窗: Up to 3 months
次要结局
- Demographic Questionnaire(Up to 3 months)
- Generalised Anxiety Disorder-7(Up to 3 months)
- Patient Health Questionnaire-9(Up to 3 months)
- Qualitative Questionnaire(Up to 3 months)
- Psychological Outcome Profiles(Up to 3 months)
研究者
Finbar Dickinson
Chief Investigator
University of Manchester