Clinical trial NCT05296538: The Mental Imagery for Suicidality in Students Trial (MISST)
Official title: The Mental Imagery for Suicidality in Students Trial (MISST): A Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation
Lead sponsor: Greater Manchester Mental Health NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The MISST study is a two-armed feasibility randomised controlled trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Recruitment Rates
timeFrame: 2 years
measure: Adherence to treatment
timeFrame: 24 weeks
measure: Suitability of proposed primary outcome
timeFrame: Through study completion, an average of 24 weeks
measure: Occurrence of Adverse Reactions
timeFrame: Through study completion, an average of 24 weeks
Secondary outcomes:
measure: Beck Scale of Suicidal Ideation (BSS)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: Beck Hopelessness Scale (BHS)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: Defeat and Entrapment Scale short-form (DES - short)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: Perceived Control of Internal States Scale (PCISS)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: Patient Health Questionnaire (PHQ9)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
measure: The Self-Injurious Thoughts and Behaviours Interview (SITBI) + Linehan Suicide Attempt-Self-Injury Interview (SASII)
timeFrame: Baseline, 8-weeks, 16-weeks, 24-weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Trust
Study officials:
References: