The Mental Imagery for Suicidality in Students Trial (MISST): A Feasibility Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Adherence to treatment
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Researchers conducting assessments will be masked to treatment allocation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Adherence to treatment
Time Frame: 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%.
Recruitment Rates
Time Frame: 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
Time Frame: 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.
Suitability of proposed primary outcome
Time Frame: 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%.
Secondary Outcomes
- 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)
- The Self-Injurious Thoughts and Behaviours Interview (SITBI) + Linehan Suicide Attempt-Self-Injury Interview (SASII)(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)
- Positive and Negative Affect Schedule (PANAS)(Baseline, 8-weeks, 16-weeks, 24-weeks)
- Perceived Stress Scale (PSS)(Baseline, 8-weeks, 16-weeks, 24-weeks)
Investigators
Peter Taylor
Senior Clinical Lecturer
Greater Manchester Mental Health NHS Foundation Trust