The Mental Imagery for Suicidality in Students Trial (MISST)
- Conditions
- Suicidal IdeationSuicide, Attempted
- Interventions
- Other: Risk Assessment and SignpostingOther: Broad-Minded Affective Coping Intervention
- Registration Number
- NCT05296538
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risk assessment and signposting + Treatment As Usual 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. In addition they will be able to access usual care from their University counselling service or other health services. Broad-Minded Affective Coping Intervention + Risk assessment and signposting Broad-Minded Affective Coping Intervention 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. Broad-Minded Affective Coping Intervention + Risk assessment and signposting 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.
- Primary Outcome Measures
Name Time Method Adherence to treatment 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 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 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 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 Outcome Measures
Name Time Method Defeat and Entrapment Scale short-form (DES - short) Baseline, 8-weeks, 16-weeks, 24-weeks This is an 8-item questionnaire measuring feelings of defeat and entrapment. Items are scored on a scale from 0 to 4, with total scores ranging from 0 to 32, higher scores indicating greater perceived defeat and entrapment.
Generalised Anxiety Disorder Assessment (GAD-7) Baseline, 8-weeks, 16-weeks, 24-weeks This is a 7-item questionnaire measuring anxiety symptoms over the preceding two weeks. Items are scored on a scale from 0 to 3, with total scores ranging from 0 to 21, higher scores indicating greater anxiety.
Perceived Control of Internal States Scale (PCISS) Baseline, 8-weeks, 16-weeks, 24-weeks This is an 18-item questionnaire measuring perceived control of internal states (e.g. emotions and cognitions). Items are scored on a scale from 1 to 5, with total scores ranging from 18 to 90, where higher scores indicating greater perceived control.
Patient Health Questionnaire (PHQ9) Baseline, 8-weeks, 16-weeks, 24-weeks This is a 9-item questionnaire measuring depressive symptoms over the preceding two weeks. Items are scored on a scale from 0 to 3, with total scores ranging from 0 to 27, where higher scores indicating greater depression.
The Self-Injurious Thoughts and Behaviours Interview (SITBI) + Linehan Suicide Attempt-Self-Injury Interview (SASII) Baseline, 8-weeks, 16-weeks, 24-weeks The SITBI is a structured interview designed to assess self-injurious and suicidal thoughts and behaviours. The sections relating to suicide attempt and non-suicidal self-injury will be used. In these sections the frequency of suicidal and self-injurious behaviour over the preceding year, month, and week is assessed. These data on occurrence of suicidal and self-injurious behaviour will be used as a secondary outcome in the trial. Items adapted from the SASII regarding the frequency of self-harm occurring over one's life and since the last assessment, will also be used to supplement the SASII in assessing suicidal and self-injurious behaviour. Frequency of suicidal or self-harm behaviour since the previous assessment point will be recorded at each follow-up assessment using these measures.
Beck Scale of Suicidal Ideation (BSS) Baseline, 8-weeks, 16-weeks, 24-weeks This is a 21-item questionnaire measuring suicidal thinking over the past week. Items are scored on a scale from 0 to 2, with total scores ranging from 0 to 38, higher scores indicating greater suicidal ideation.
Beck Hopelessness Scale (BHS) Baseline, 8-weeks, 16-weeks, 24-weeks This is a 20-item questionnaire measuring feelings of hopelessness over the past week. Items are scored on a scale from 0 to 1 (true or false), with total scores ranging from 0 to 20, higher scores indicating greater hopelessness.
Positive and Negative Affect Schedule (PANAS) Baseline, 8-weeks, 16-weeks, 24-weeks This is a 20-item questionnaire measuring positive and negative affective states. Items are scored on a scale from 0 to 5, with total scores ranging from 0 to 50 for the negative affect and positive affect subscales, where higher scores indicating experience of greater positive and negative affect, respectively.
Perceived Stress Scale (PSS) Baseline, 8-weeks, 16-weeks, 24-weeks This is a 10-item questionnaire measuring stress over the preceding month. Items are scored on a scale from 0 to 4, with total scores ranging from 0 to 40, where higher scores indicating greater stress.
Trial Locations
- Locations (1)
Greater Manchester Mental Health NHS Trust
🇬🇧Manchester, United Kingdom