The Mental Imagery for Suicidality in Students Trial (MISST): A Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Adherence to treatment
研究概览
简要总结
In the UK, suicide is the leading cause of death in young people and have increased in recent years. Areas in the North of England appear particularly at risk. University students represent one vulnerable group. 42% of students contemplate suicide in any one-year period. Suicidal thinking is an important indicator of distress and clinical need, which predicts subsequent suicidal experiences and worse mental health. It is therefore an important target for clinical treatment and early intervention. However, evidenced based interventions for targeting suicidal thinking in students are lacking.
This project will evaluate the feasibility of a novel psychological intervention, called the Broad Minded Affective Coping (BMAC) intervention. The BMAC aims to increase peoples' access to positive thoughts and emotions to help them to break out of cycles of negative mood and suicidal thinking. It is targeted, protocolised, and deliverable by a range of professional groups. Our existing co-development work with young people has suggested that it is acceptable and helpful to University students. This randomised controlled feasibility trial of the BMAC intervention for suicidal thinking in university students. Participants will be randomised to either a risk assessment and signposting plus the BMAC (n = 33), or risk assessment and signposting alone (n = 33). The study will assess outcomes at baseline and after eight weeks, 16 weeks, and 24 weeks. The study will explore the safety, feasibility and acceptability of delivering the intervention and trial procedures. Embedded qualitative interviews with staff and participants, and field notes, will help us to understand the potential factors affecting acceptability and delivery of the BMAC intervention and conduct of the trial, and the proposed underlying mechanisms of change. The project will be a crucial step in evaluating the BMAC for suicidal students, paving the way for a larger trial of clinical effectiveness.
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
- Single (Outcomes Assessor)
盲法说明
Researchers conducting assessments will be masked to treatment allocation
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
- •Aged ≥18 years.
- •Accessing full or part time education through a Higher Education Institution (HEI).
- •Suicidal ideation and/or behaviours in the past three months
排除标准
- •Active/historical full threshold first episode psychosis or bipolar disorder
- •Known moderate to severe learning disability (IQ:<70).
- •Organic cerebral disease/injury affecting receptive and expressive language comprehension.
- •Non-English speaking to the degree that the participant is unable to answer questions and give written informed consent.
- •Imminent and immediate risk to self or others, operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month).
研究组 & 干预措施
Broad-Minded Affective Coping Intervention + Risk assessment and signposting
Participants will first receive one to two 50 minute sessions focused on risk assessment and management, including signposting to further support. They will then be offered six sessions of the Broad-Minded Affective Coping (BMAC) Intervention. Sessions will take place weekly where possible and the intervention window will be eight weeks. A booster session will be offered in the 8 weeks following the end of therapy.
干预措施: Broad-Minded Affective Coping Intervention (Other)
Broad-Minded Affective Coping Intervention + Risk assessment and signposting
Participants will first receive one to two 50 minute sessions focused on risk assessment and management, including signposting to further support. They will then be offered six sessions of the Broad-Minded Affective Coping (BMAC) Intervention. Sessions will take place weekly where possible and the intervention window will be eight weeks. A booster session will be offered in the 8 weeks following the end of therapy.
干预措施: Risk Assessment and Signposting (Other)
Risk assessment and signposting + Treatment As Usual
Participants will first receive one to two 50 minute sessions focused on risk assessment and management, including signposting to further support. In addition they will be able to access usual care from their University counselling service or other health services.
干预措施: Risk Assessment and Signposting (Other)
结局指标
主要结局
Adherence to treatment
时间窗: 24 weeks
Percentage of participants receiving the minimum dose of BMAC therapy (≥2 sessions) within eight-week treatment window. Traffic light targets for the percentage of the target sample receiving the minimum dose is as follows: Green: ≥80%. Amber: 60-\<80%. Red: \<60%.
Suitability of proposed primary outcome
时间窗: Through study completion, an average of 24 weeks
Informed by qualitative workstream plus percentage of participants completing the Beck Scale for Suicidal ideation y(BSS) at all timepoints. Targets for the proportion of participants completing the BSS is as follows: Green: ≥80%. Amber: 60-\<80%. Red: \<60%.
Recruitment Rates
时间窗: 2 years
Ability to randomise 66 participants in an 11-month recruitment window. Traffic light targets for the percentage of the target sample recruited is as follows: Green: ≥80%. Amber 60-\<80%. Red \<60%.
Occurrence of Adverse Reactions
时间窗: Through study completion, an average of 24 weeks
Monitoring and review of research related serious adverse events (SAEs). The Trial Steering Committee (TSC) will oversee SAEs across treatment arms.
次要结局
- Defeat and Entrapment Scale short-form (DES - short)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Generalised Anxiety Disorder Assessment (GAD-7)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Perceived Control of Internal States Scale (PCISS)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Patient Health Questionnaire (PHQ9)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Beck Scale of Suicidal Ideation (BSS)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Beck Hopelessness Scale (BHS)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- The Self-Injurious Thoughts and Behaviours Interview (SITBI) + Linehan Suicide Attempt-Self-Injury Interview (SASII)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Positive and Negative Affect Schedule (PANAS)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Perceived Stress Scale (PSS)(Baseline, 8-weeks, 16-weeks, 24-weeks)
研究者
Peter Taylor
Senior Clinical Lecturer
Greater Manchester Mental Health NHS Foundation Trust