Is it possible to conduct a study of a positive mental imagery intervention in students with suicidal thinking and/or behaviour?

ISRCTN	ISRCTN13621293
DOI	https://doi.org/10.1186/ISRCTN13621293
ClinicalTrials.gov (NCT)	NCT05296538
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	305348
Protocol serial number	IRAS 305348, CPMS 51344
Sponsor	Greater Manchester Mental Health NHS Foundation Trust
Funder	National Institute for Health Research

Submission date: 13/12/2021
Registration date: 17/12/2021
Last edited: 27/05/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Suicide is the main cause of death in young people. Many students experience suicidal thoughts. These thoughts can be distressing. They can lead to suicide attempts and worse mental health. University and NHS services typically manage this risk. However, there are few evidence based treatments for targeting suicidal thinking.

We want to evaluate a new talking therapy called the Broad-Minded Affective Coping (BMAC) intervention. It is brief, structured, and easily used by student services. The BMAC asks people to revisit and focus on positive memories and experiences. This may help people to break out of cycles of suicidal thinking. We want to see whether we can do a trial of the BMAC.

Who can participate?
Students aged 18 years or older, with suicidal thoughts.

What does the study involve?
We will recruit 66 students with suicidal thoughts to a clinical trial. We will randomly assign 33 students to receiving risk assessment and signposting. The other 33 students will receive risk assessment and signposting plus the BMAC. We will assess students’ suicidal thinking and other difficulties at the start of trial and after eight, 16 and 24 weeks. We will explore whether young people are happy to complete the clinical assessments and the BMAC.
We will interview students and staff as they finish the trial. Staff will also keep detailed notes of their experiences. This will help us to understand how people found the therapy and the trial. The results will improve the BMAC for young people. It will help to plan a larger study. We will work with young people to decide how to best share our findings.

What are the possible benefits and risks of participating?
Although the study asks participants about sensitive information, participants sometimes report taking part in research rewarding.

Where is the study run from?
Greater Manchester Mental Health NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2021 to October 2023

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Palmier-Claus, j.palmier-claus@lancaster.ac.uk

Contact information

Dr Jasper Palmier-Claus
Scientific

Health Innovation Campus
Lancaster University
Lancaster
LA1 4YW
United Kingdom

ORCID ID	0000-0002-4908-2137
Phone	+44 7742781645
Email	J.Palmier-Claus@lancaster.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional randomized controlled trial (feasibility study)
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The Mental Imagery for Suicidality in Students Trial (MISST): A feasibility study.
Study acronym	MISST
Study objectives	We aim to conduct a feasibility trial of a six-session BMAC intervention with University students experiencing suicidal thoughts and/or behaviours. Our overall objectives are: 1. To determine whether University students are willing to be randomised to a trial targeting suicidal experiences. 2. To understand whether it is feasible to collect clinical outcome data in this population. 3. To explore whether patients engage with the BMAC intervention. 4. To determine the safety of the intervention and trial procedures. 5. To explore the initial promise of the intervention, in terms of impact upon clinical outcomes. 6. To investigate what aspects of suicidal experiences might be an appropriate primary clinical outcome for a full trial 7. To understand the potential factors affecting (e.g. facilitators and barriers) acceptability and delivery. 8. To gather participant and staff feedback to configure and optimise the intervention and full-scale trial design.
Ethics approval(s)	Approved 08/12/2021, London - Bromley Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 207 104 8105; bromley.rec@hra.nhs.uk), ref: 21/LO/0897
Health condition(s) or problem(s) studied	Suicidal thinking and/or behaviour
Intervention	We will randomly allocate (1:1 ratio; random block size) participants to either, up to: - Two sessions of risk assessment and signposting (control) over eight weeks. - Two sessions of risk assessment and signposting plus six sessions and a booster session of the Broad Minded Affective Coping (BMAC) intervention over eight weeks. BMAC intervention: A clinician will ask people to identify, revisit and rehearse positive memories in order to strengthen alternative patterns of thinking that then compete with and reduce repetitive suicidal thoughts. The sessions with typically last one hour and can be delivered face-to-face or remotely via telephone/video calls.
Intervention type	Behavioural
Primary outcome measure(s)	Feasibility outcomes measured using participant records: 1. Recruitment rates: Ability to randomise 66 participants in an 11-month recruitment window 2. Adherence to treatment: Percentage of participants receiving the minimum dose of therapy (≥2 sessions) within eight-week treatment window 3. Retention to follow-up: Percentage of participants completing the 24-week assessment as potential primary outcome timepoint 4. Suitability of proposed primary outcome: Informed by qualitative workstream plus percentage of participants completing the Beck Scale for Suicidal ideation at all timepoints 5. Safety of trial participation: Monitoring and review of research related serious adverse events (SAEs).
Key secondary outcome measure(s)	Measured at baseline, 8, 16 and 24 weeks: 1. Beck Scale for Suicidal Ideation 2. Linehan Suicide-Attempt Self-Injury Interview items 3. Self-injurious Thoughts and Behaviours Interview items 4. General health measured using the Patient Health Questionnaire 9 5. Anxiety measured using the Generalised Anxiety Scale 7 6. Hopelessness measured using Beck Hopelessness Scale 7. Defeat and entrapment measured using Defeat and Entrapment scales 8. Perceived Stress Scale 9. Emotion measured using the Positive and Negative Affect Schedule 10. Perceived Control of Internal States Scale
Completion date	24/10/2023

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	66
Key inclusion criteria	1. Aged ≥18 years 2. Accessing full or part time education through a HEI 3. Suicidal ideation and/or behaviours in the past three months, ascertained using the questions ‘have you had any thoughts about ending your life in the past three months?’ and ‘have you attempted to end your life in the past three months?’. Endorsement of either item will confirm eligibility for the trial and progression to full assessment. This approach is consistent with previous trials and is sensitive to detecting suicidal experiences amongst adults
Key exclusion criteria	1. Active/historical full threshold first episode psychosis or bipolar disorder as identified by the patient or referring service and the MINI diagnostic interview. 2. Known moderate to severe learning disability (IQ:<70). 3. Organic cerebral disease/injury affecting receptive and expressive language comprehension. 4. Non-English speaking to the degree that the participant is unable to answer questions and give written informed consent. 5. 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). Where individuals are excluded on this basis, with the person’s consent, the researcher will aim to recontact them and the referrer in approximately one-month’s time (or a time period agreed in collaboration with the individual) to determine if risk has subsided to a point where they are now eligible.
Date of first enrolment	24/02/2022
Date of final enrolment	24/01/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Prestwich Hospital

Greater Manchester Mental Health NHS Foundation Trust
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Following publication of the trial results, we will make suitable arrangements for anonymised data to be available from the Research Team, in line with NIHR data sharing guidance. Data available from Jasper Palmier-Claus, J.Palmier-Claus@lancaster.ac.uk, raw data, at least five years, for the purpose of relevant research into suicidality in students at the discretion of the research team, we will be gathering informed consent from participants to this purpose.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		20/05/2025	27/05/2025	Yes	No
Protocol article		17/03/2023	20/03/2023	Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Qualitative study of participants experiences	27/09/2024	27/09/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	version 1	22/06/2023	06/10/2023	No	No

Additional files

ISRCTN13621293_SAP_v1_22June2023.pdf: Statistical Analysis Plan

Editorial Notes

27/05/2025: Publication reference added.
27/09/2024: Publication reference added.
06/10/2023: Statistical analysis plan added.
20/03/2023: Publication reference added.
07/12/2022: The recruitment end date was changed from 24/11/2022 to 24/01/2023.
02/11/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 21/02/2022 to 24/02/2022.
2. The recruitment end date was changed from 24/11/2022 to 24/02/2023.
11/01/2022: The CPMS number was added to the protocol/serial no. field.
10/01/2022: The recruitment start date was changed from 24/01/2022 to 21/02/2022.
16/12/2021: Trial's existence confirmed by London - Bromley Research Ethics Committee