The Mental Imagery for Suicidality in Students Trial (MISST)

NCT05296538 | Completed

• 1 other identifier: x557s IRAS 305348
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted; Suicidal Ideation

Outcome Measures

Primary Outcomes (4)

• 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%.

  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%.

  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%.

  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.

  Through study completion, an average of 24 weeks

Secondary Outcomes (9)

• Beck Scale of Suicidal Ideation (BSS)

  Baseline, 8-weeks, 16-weeks, 24-weeks

• Beck Hopelessness Scale (BHS)

  Baseline, 8-weeks, 16-weeks, 24-weeks

• Defeat and Entrapment Scale short-form (DES - short)

  Baseline, 8-weeks, 16-weeks, 24-weeks

• Generalised Anxiety Disorder Assessment (GAD-7)

  Baseline, 8-weeks, 16-weeks, 24-weeks

• Positive and Negative Affect Schedule (PANAS)

  Baseline, 8-weeks, 16-weeks, 24-weeks

Study Arms (2)

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.

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.

Other: Risk Assessment and Signposting

Interventions

Broad-Minded Affective Coping Intervention OTHER

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.

Broad-Minded Affective Coping Intervention + Risk assessment and signposting

Risk Assessment and Signposting OTHER

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.

Broad-Minded Affective Coping Intervention + Risk assessment and signposting; Risk assessment and signposting + Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Greater Manchester Mental Health NHS Foundation Trust: lead

Study Sites (1)

Greater Manchester Mental Health NHS Trust

Manchester, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40411963 DERIVED

• Taylor 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.

  PMID: 36932430 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers conducting assessments will be masked to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer

Model Details: The MISST study is a two-armed feasibility randomised controlled trial.

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 25, 2022
• Study Start: February 21, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

GB (1)