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The Mental Imagery for Suicidality in Students Trial (MISST) (MISST)

Primary Purpose

Suicide, Attempted, Suicidal Ideation

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Broad-Minded Affective Coping Intervention
Risk Assessment and Signposting
Sponsored by
Greater Manchester Mental Health NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Greater Manchester Mental Health NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Broad-Minded Affective Coping Intervention + Risk assessment and signposting

Risk assessment and signposting + Treatment As Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%.
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%.
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%.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 11, 2022
Last Updated
September 12, 2023
Sponsor
Greater Manchester Mental Health NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05296538
Brief Title
The Mental Imagery for Suicidality in Students Trial (MISST)
Acronym
MISST
Official Title
The Mental Imagery for Suicidality in Students Trial (MISST): A Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
October 24, 2023 (Anticipated)
Study Completion Date
October 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Greater Manchester Mental Health NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The MISST study is a two-armed feasibility randomised controlled trial.
Masking
Outcomes Assessor
Masking Description
Researchers conducting assessments will be masked to treatment allocation
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Broad-Minded Affective Coping Intervention + Risk assessment and signposting
Arm Type
Experimental
Arm Description
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.
Arm Title
Risk assessment and signposting + Treatment As Usual
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Broad-Minded Affective Coping Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Risk Assessment and Signposting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rates
Description
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
Title
Adherence to treatment
Description
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
Title
Suitability of proposed primary outcome
Description
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
Title
Occurrence of Adverse Reactions
Description
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
Secondary Outcome Measure Information:
Title
Beck Scale of Suicidal Ideation (BSS)
Description
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
Title
Beck Hopelessness Scale (BHS)
Description
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
Title
Defeat and Entrapment Scale short-form (DES - short)
Description
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
Title
Generalised Anxiety Disorder Assessment (GAD-7)
Description
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
Title
Positive and Negative Affect Schedule (PANAS)
Description
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
Title
Perceived Control of Internal States Scale (PCISS)
Description
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
Title
Patient Health Questionnaire (PHQ9)
Description
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
Title
Perceived Stress Scale (PSS)
Description
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
Title
The Self-Injurious Thoughts and Behaviours Interview (SITBI) + Linehan Suicide Attempt-Self-Injury Interview (SASII)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Greater Manchester Mental Health NHS Trust
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Mental Imagery for Suicidality in Students Trial (MISST)

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