Suicide, AttemptedMISSTNCT05296538
The Mental Imagery for Suicidality in Students Trial (MISST)
A study testing Broad-Minded Affective Coping Intervention and Risk Assessment and Signposting in people with Suicide, Attempted and Suicidal Ideation, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Broad-Minded Affective Coping Intervention and Risk Assessment and Signposting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2022to 24 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Greater Manchester Mental Health NHS Trust
Manchester
About this study
Official title: The Mental Imagery for Suicidality in Students Trial (MISST): A Feasibility Study.
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.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Being tested
- Broad-Minded Affective Coping Intervention, Risk Assessment and Signposting
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad-Minded Affective Coping InterventionOther
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.
Risk Assessment and SignpostingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Broad-Minded Affective Coping Intervention + Risk assessment and signposting | Experimental | 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. Receives: Other: Broad-Minded Affective Coping Intervention; Other: Risk Assessment and Signposting |
| Risk assessment and signposting + Treatment As Usual | Other | 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. Receives: Other: Risk Assessment and Signposting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: Through study completion, an average of 24 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8-weeks, 16-weeks, 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start21 Feb 2022
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The MISST study is a two-armed feasibility randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Taylor, Greater Manchester Mental Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296538
- Sponsor's protocol ID
- x557s IRAS 305348
- Acronym
- MISST
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palmier-Claus J, Duxbury P, Pratt D, Parker S, Sutton C, Lobban F, Moorhouse J, Kerry E, Russell C, Nyakutsikwa B, Drake R, Eccles S, Randles N, Patel R, Kelly J, Tattersall R, Taylor PJ. A mental imagery intervention targeting suicidal ideation in university students: An assessor-blind, randomised controlled feasibility trial. Behav Res Ther. 2025 Aug;191:104780. doi: 10.1016/j.brat.2025.104780. Epub 2025 May 20.
PubMed 40411963Taylor PJ, Duxbury P, Moorhouse J, Russell C, Pratt D, Parker S, Sutton C, Lobban F, Drake R, Eccles S, Ryder D, Patel R, Kimber E, Kerry E, Randles N, Kelly J, Palmier-Claus J. The Mental Imagery for Suicidality in Students Trial (MISST): study protocol for a feasibility randomised controlled trial of broad-minded affective coping (BMAC) plus risk assessment and signposting versus risk assessment and signposting alone. Pilot Feasibility Stud. 2023 Mar 17;9(1):43. doi: 10.1186/s40814-023-01273-7.
PubMed 36932430
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mental Imagery for Suicidality in Students Trial (MISST): A Feasibility Study.
- ClinicalTrials.gov ID
- NCT05296538
- Acronym / sponsor ID
- MISST / x557s IRAS 305348
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The MISST study is a two-armed feasibility randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Broad-Minded Affective Coping Intervention + Risk assessment and signposting | Experimental | Other: Broad-Minded Affective Coping Intervention, Other: Risk Assessment and SignpostingParticipants 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. |
| Risk assessment and signposting + Treatment As Usual | Other | Other: Risk Assessment and SignpostingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad-Minded Affective Coping InterventionThe 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. | Other | Broad-Minded Affective Coping Intervention + Risk assessment and signposting |
| Risk Assessment and SignpostingA 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. | Other | Broad-Minded Affective Coping Intervention + Risk assessment and signposting, Risk assessment and signposting + Treatment As Usual |
Primary outcome
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%.
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%.
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%.
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.
9 secondary outcomes
Beck Scale of Suicidal Ideation (BSS)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Beck Hopelessness Scale (BHS)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Defeat and Entrapment Scale short-form (DES - short)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Perceived Control of Internal States Scale (PCISS)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Patient Health Questionnaire (PHQ9)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Perceived Stress Scale (PSS)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
The Self-Injurious Thoughts and Behaviours Interview (SITBI) + Linehan Suicide Attempt-Self-Injury Interview (SASII)
Time frame: Baseline, 8-weeks, 16-weeks, 24-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 40411963Palmier-Claus J, Duxbury P, Pratt D, Parker S, Sutton C, Lobban F, Moorhouse J, Kerry E, Russell C, Nyakutsikwa B, Drake R, Eccles S, Randles N, Patel R, Kelly J, Tattersall R, Taylor PJ. A mental imagery intervention targeting suicidal ideation in university students: An assessor-blind, randomised controlled feasibility trial. Behav Res Ther. 2025 Aug;191:104780. doi: 10.1016/j.brat.2025.104780. Epub 2025 May 20.
- Derived from this study: PubMed 36932430Taylor PJ, Duxbury P, Moorhouse J, Russell C, Pratt D, Parker S, Sutton C, Lobban F, Drake R, Eccles S, Ryder D, Patel R, Kimber E, Kerry E, Randles N, Kelly J, Palmier-Claus J. The Mental Imagery for Suicidality in Students Trial (MISST): study protocol for a feasibility randomised controlled trial of broad-minded affective coping (BMAC) plus risk assessment and signposting versus risk assessment and signposting alone. Pilot Feasibility Stud. 2023 Mar 17;9(1):43. doi: 10.1186/s40814-023-01273-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broad-Minded Affective Coping Intervention and Risk Assessment and Signposting in people with Suicide, Attempted and Suicidal Ideation, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296538, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.