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

Not Applicable

• Conditions: Suicidal thinking and/or behaviour; Mental and Behavioural Disorders

• Registration Number: ISRCTN13621293
• Lead Sponsor: Greater Manchester Mental Health NHS Foundation Trust

Brief Summary

2023 Protocol article in https://doi.org/10.1186/s40814-023-01273-7 (added 20/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-17
• Last Update Posted: 16 October 2023
• Study Completion: 2023-10-24

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 66

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility outcomes measured using participant records: 1. Recruitment rates: Ability to randomise 66 participants in an 11-month recruitment window2. Adherence to treatment: Percentage of participants receiving the minimum dose of therapy (=2 sessions) within eight-week treatment window3. Retention to follow-up: Percentage of participants completing the 24-week assessment as potential primary outcome timepoint4. Suitability of proposed primary outcome: Informed by qualitative workstream plus percentage of participants completing the Beck Scale for Suicidal ideation at all timepoints5. Safety of trial participation: Monitoring and review of research related serious adverse events (SAEs).

Secondary Outcome Measures

Name	Time	Method
Measured at baseline, 8, 16 and 24 weeks:1. Beck Scale for Suicidal Ideation2. Linehan Suicide-Attempt Self-Injury Interview items3. Self-injurious Thoughts and Behaviours Interview items4. General health measured using the Patient Health Questionnaire 9 5. Anxiety measured using the Generalised Anxiety Scale 76. Hopelessness measured using Beck Hopelessness Scale7. Defeat and entrapment measured using Defeat and Entrapment scales8. Perceived Stress Scale9. Emotion measured using the Positive and Negative Affect Schedule10. Perceived Control of Internal States Scale