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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
The Broad-Minded Affective Coping (BMAC) is a six session intervention that uses mental imagery and rehearsal of memories of past positive experiences to generate positive emotions in the moment. A further follow-up session is provided in the eight weeks following the end of treatment.
A therapist will meet with participants over two 50 minute sessions to conduct a comprehensive risk assessment, and develop a collaborative plan with the participant around managing any risk, including identification of sources of support and signposting.
Greater Manchester Mental Health NHS Trust
Manchester, United Kingdom
Recruitment Rates
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%.
Time frame: 2 years
Adherence to treatment
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%.
Time frame: 24 weeks
Suitability of proposed primary outcome
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%.
Time frame: Through study completion, an average of 24 weeks
Occurrence of Adverse Reactions
Monitoring and review of research related serious adverse events (SAEs). The Trial Steering Committee (TSC) will oversee SAEs across treatment arms.
Time frame: Through study completion, an average of 24 weeks
Beck Scale of Suicidal Ideation (BSS)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Beck Hopelessness Scale (BHS)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Defeat and Entrapment Scale short-form (DES - short)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Generalised Anxiety Disorder Assessment (GAD-7)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Positive and Negative Affect Schedule (PANAS)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Perceived Control of Internal States Scale (PCISS)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Patient Health Questionnaire (PHQ9)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Perceived Stress Scale (PSS)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
The Self-Injurious Thoughts and Behaviours Interview (SITBI) + Linehan Suicide Attempt-Self-Injury Interview (SASII)
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.
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
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