Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000078459
Ethics application status
Approved
Date submitted
19/12/2024
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Preliminary study of the SUicide IMagery REScripting (SUIMRES) treatment for adults experiencing mental images of suicide.
Scientific title
A Randomised-Controlled Feasibility Trial of SUicide IMagery REScripting (SUIMRES): A psychotherapy adjunct for mental images of suicide in adults
Secondary ID [1] 313597 0
None
Universal Trial Number (UTN)
U1111-1317-0093
Trial acronym
SUIMRES-FT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide ideation involving mental imagery (suicide imagery). 336140 0
Condition category
Condition code
Mental Health 332689 332689 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SUicide IMagery REScripting (SUIMRES) Intervention + Treatment As Usual (SUIMRES + TAU)
Participants allocated to this arm will continue TAU as per the control arm, with the addition of the SUicide IMagery REScripting (SUIMRES) intervention to be delivered via telehealth videoconferencing. SUIMRES is an adjunctive psychotherapy intervention delivered over 3-4 sessions in individual sessions with a qualified psychologist experienced in Imagery Rescripting and working with patients experiencing suicide ideation. The first two sessions are to be completed weekly to fortnightly, with timing of optional session 4 negotiated on a case-by-case basis (but this must be held within 6-8 weeks of starting SUIMRES). Thus, the total duration of the intervention will be between 3 (if only 3 sessions are completed and are completed weekly) and up to 8 weeks. Sessions are expected to last 90 minutes each but some may finish earlier (e.g., consolidation of imagery in Session 3 if the participant does not have additional imagery requiring rescripting).

SUIMRES covers seven topics: (A) Assessment, Psychoeducation, and Identifying Imagery Target, (B) Imagery Rescripting as Rehearsal of Implementation Intention, and (C) Consolidation of Rescripted Image, Troubleshooting, or Practice with Additional Images, (D) Addressing the Impact of Memory-Based Imagery, (E) Incorporating Ambivalence Imagery, (F) Imagery to Connect with Future Self, and (G) Relapse Prevention.

Sessions 1-3 include prescribed content that has been carefully designed to address key mechanisms through which suicide imagery may increase the risk of suicide behaviour.
1. Session 1 will cover Topic A (Assessment, Psychoeducation, and Identifying an Imagery Target)
2. Session 2 will cover Topic B (Imagery Rescripting as Rehearsal of Implementation Intention)
3. Session 3 will cover Topic C (Consolidation of Rescripted Image, Troubleshooting, or Practice with Additional Images) and if the final session should include Topic G Relapse prevention.

Session 4 is optional and somewhat flexible in content. It may include recapping of content from Topics A-C, content from Topics D-F, or other relevant strategies.

Adherence to the intervention will be assessed by requiring study therapists to complete a post-session questionnaire after each session. This questionnaire will require the therapists to select the intervention components have been utilised during that session, as well as indicating (a) whether other additional strategies were used (which therapists will be asked to describe), and (b) whether participants completed requested home practice tasks between sessions where applicable.

This study will include assessment of the feasibility of the evaluation protocol used in this study and proposed for use in a future fully powered efficacy trial. The evaluation protocol includes the collection of data from people experiencing suicide imagery who enrol in the trial (primary participants), their usual-care therapists (secondary participants), and the trial clinicians who administer the intervention. The evaluation protocol includes questionnaires that are administered to primary participants at baseline, post-treatment (after their final session), and at follow-up (4 weeks after their final session). At this time the primary participants also complete a research participation feedback survey. After every therapy session the trial clinicians also complete a session summary form outlining the content of the session and patient engagement, as well as other relevant clinical information (e.g., risk assessments). The evaluation protocol also includes an online survey administered to secondary participants regarding the primary participants' therapeutic engagement in usual care, observations of the primary participants' engagement with SUIMRES (for those in the SUIMRES arm), and the secondary participants' experiences of communication and engagement with the trial team. After each trial clinician's final participant has completed all therapy sessions the trial clinicians also complete a survey regarding their experiences of both the SUIMRES intervention and of the trial protocol.
Intervention code [1] 330194 0
Treatment: Other
Intervention code [2] 330195 0
Behaviour
Comparator / control treatment
Treatment As Usual (TAU) Control
Participants allocated to this arm will continue with Treatment as Usual (TAU) as determined by their usual-care therapist. This may include continuance with their regular medications and/or psychotherapy, without the additional intervention described for the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 340214 0
Feasibility of the intervention.
Timepoint [1] 340214 0
The Session Summary Form will be completed after every therapy session, while the Trial Therapist Feedback Survey will be completed as each therapist’s final patient completes treatment.
Primary outcome [2] 340215 0
Safety of the intervention.
Timepoint [2] 340215 0
Baseline, post-treatment, 4 weeks post-treatment (primary timepoint).
Primary outcome [3] 340216 0
Acceptability of the intervention.
Timepoint [3] 340216 0
4 weeks post-treatment
Secondary outcome [1] 443344 0
Acceptability of the intervention to participants’ usual-care therapists.
Timepoint [1] 443344 0
4 weeks post-treatment.
Secondary outcome [2] 443345 0
Feasibility of the trial evaluation protocol for use in subsequent full-scale efficacy trial - recruitment.
Timepoint [2] 443345 0
At the conclusion of participant recruitment for the trial (either after the final participant has been enrolled and randomised, or if the trial is terminated without recruiting all intended participants, at that time).
Secondary outcome [3] 443346 0
Feasibility of the trial evaluation protocol for use in subsequent full-scale efficacy trial.
Timepoint [3] 443346 0
Baseline, post-treatment, 4 weeks post-treatment.
Secondary outcome [4] 443347 0
Feasibility of the trial evaluation protocol for use in subsequent full-scale efficacy trial.
Timepoint [4] 443347 0
4 weeks post-treatment.
Secondary outcome [5] 443348 0
Acceptability of research procedures to participants.
Timepoint [5] 443348 0
4 weeks post-treatment.
Secondary outcome [6] 443349 0
Suicide imagery severity.
Timepoint [6] 443349 0
Baseline, post-treatment, 4 weeks post-treatment (primary timepoint).
Secondary outcome [7] 443350 0
Use of adaptive coping and safety plan skills.
Timepoint [7] 443350 0
Baseline, post-treatment, 4 weeks post-treatment (primary timepoint).
Secondary outcome [8] 443351 0
Metacognitions about suicide imagery.
Timepoint [8] 443351 0
Baseline, post-treatment, 4 weeks post-treatment (primary timepoint).
Secondary outcome [9] 443352 0
Characteristics of Treatment As Usual.
Timepoint [9] 443352 0
4 weeks post-treatment.

Eligibility
Key inclusion criteria
Individuals will be eligible to participate if they:
- Currently (in the past month) experience suicide ideation that consists of mental images (mentally picturing or imagining suicide or the impacts of suicide on yourself or other people)
- have an existing AHPRA-registered therapist (e.g. psychologist, psychiatrist) whom they see regularly (or have access to if required) for treatment within Australia, who agrees to referring the patient to the trial, and who also consents to act as a secondary participant (i.e., complete a short survey after the trial),
- have a written safety plan created in partnership with this therapist that will be shared with the trial team (e.g., BeyondNow Safety Plan),
- have existing coping strategies for managing periods of distress that will be shared with the trial team. The imagery intervention may enhance the application of coping skills, but should not serve as a foundational introduction to coping skills,
- consent to communication between their usual-care therapist and the trial team regarding their care, progress, and risk issues.
- are an adult aged over 18 years who can read and speak English Fluently,
- reside in Australia and will do so for the duration of the trial,
- can access the internet in a private location on a device suitable for attending telehealth consultations, AND
- can attend telehealth consultations during Monday to Friday business hours NSW or WA time (09:00-17:00).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be ineligible to participate if they:
- feel as though their mental imagery of suicide is helpful and protective against suicide (this intervention will seek to treat suicide imagery that is unhelpful or not protective).
- have experienced active intention to suicide or taken behavioural steps to prepare to suicide in the past three months, OR
- have experienced a significant mental health crisis over the past three months (requiring emergency department attendance, inpatient admission, or engagement with acute care team services), unless this was in relation to a specific external event (e.g., redundancy, bereavement) which has been resolved to the extent that the patient, usual-care therapist, and trial intake psychologist agree that the patient is stable and ready to participate OR
- based on the clinical judgement of (a) their usual-care therapist or (b) the trial team, are deemed to not be suitable for the trial at this time (e.g., require further practice with coping strategies or stabilisation, presence of higher priority symptoms that are more important to address prior to the imagery or might interfere with engagement in the trial or trial involvement might compromise treatment of such, or therapy-interfering behaviours), OR
- have a usual-care therapist that does not consent to referral or participation in the trial as a secondary participant (i.e., completing the post-trial questionnaire), OR
- are current patients of a member of the trial research team.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes - admission to trial to temporally precede random allocation to trial arms. Randomisation to be undertaken by third party not involved in the Trial using Minimpy2 software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomly allocated to SUIMRES + TAU vs TAU alone via minimisation in a 1:1 ratio using Minimpy2. Variables to be balanced in minimisation include gender (man, woman, other gender responses) and lifetime persistence of suicide ideation indexed as a percentage of years lived (<51% of life have experienced suicide ideation vs >50% of life have experienced suicide ideation) calculated by: current age – age of suicide ideation onset)/current age. When a participant is ready to be allocated, the list holder will be contacted, and the allocation provided. Participants and their usual-care therapists will be informed which arm the participant has been assigned via email.
Note that the Cochrane Handbook and Risk of Bias 2 Guidelines both acknowledge that minimisation involving a random component (as incorporated in Minimpy2) is considered to be random.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The plan is to enrol 40 participants to complete the trial who will be allocated across two conditions (SUIMRES intervention vs treatment as usual control) via minimisation. As the project is a feasibility pilot trial, it is not powered to detect efficacy. Instead, the primary aim is to assess the feasibility and acceptability of the intervention and evaluation protocol for future upscaling to a larger randomised controlled efficacy trial. A total sample size of 40 participants (20 per group) was chosen based on guidance that 12-35 participants per group is generally sufficient for pilot studies evaluating feasibility metrics (Kunselman, 2024) and as an adequate size to allow for inclusion of a range of genders in the sample. Note that participants will be allocated to groups using minimisation which will include gender as a variable to be balanced between groups (man, woman, and other gender responses). The sample size will allow us to evaluate key feasibility metrics such as recruitment rates and success of recruitment (including for different genders, noting that male participants have been historically difficult to recruit in studies of suicidality conducted by our group), and retention (including attrition) rates. This information will inform decision-making regarding recruitment strategies and the sample sizes required for a future efficacy randomised controlled trial when using these methods for recruitment with this population.

Quantitative acceptability and feasibility data will be evaluated through the calculation of descriptive statistics which will be compared to progression criteria following a traffic light system as recommended by Avery et al. (2017):
Red (stop)
• Safety: Identification of adverse reactions that are not able to be mitigated via amendment to protocol.
Amber (amend before progressing)
• Recruitment: inadequate recruitment (<5 referrals per month).
• Adherence: >50% allocated to SIUMRES not complete 2 sessions.
• Satisfaction: >50% of those receiving intervention report treatment satisfaction <3/5, or >50% of those participating in the trial overall report <3/5 satisfaction in the research trial.
• Outcome data: <50% provide 4-week follow-up data.
Green (continue)
• No concerning issues noted that threaten the success of the trial.

Qualitative acceptability and feasibility data will be analysed using reflexive thematic analysis (Braun & Clarke, 2020) underpinned by an inductive approach wherein themes will be derived from the content of the responses.

Continuous quantitative outcomes (DASS-21, continuous SITBI-R items, USIS, SIMQ) will be compared across groups across pre-treatment, post-treatment and follow-up using linear mixed models (LMM), with Time as a fixed within-group factor (pre-, post-, follow-up) and Group as a fixed between-group factor (TAU vs. TAU+SUIMRES).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
22/09/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318068 0
Government body
Name [1] 318068 0
Suicide Prevention Australia
Country [1] 318068 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 320423 0
None
Name [1] 320423 0
Address [1] 320423 0
Country [1] 320423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316717 0
The University of New South Wales Committee C
Ethics committee address [1] 316717 0
Ethics committee country [1] 316717 0
Australia
Date submitted for ethics approval [1] 316717 0
01/10/2024
Approval date [1] 316717 0
09/12/2024
Ethics approval number [1] 316717 0
irecs7131

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138770 0
Dr Ann Martin
Address 138770 0
Black Dog Institute, University of New South Wales, Sydney Hospital Rd, Randwick NSW 2031 Australia
Country 138770 0
Australia
Phone 138770 0
+61 2 9348 0183
Fax 138770 0
Email 138770 0
[email protected]
Contact person for public queries
Name 138771 0
Ann Martin
Address 138771 0
Black Dog Institute, University of New South Wales, Sydney Hospital Rd, Randwick NSW 2031 Australia
Country 138771 0
Australia
Phone 138771 0
+61 2 9348 0183
Fax 138771 0
Email 138771 0
[email protected]
Contact person for scientific queries
Name 138772 0
Ann Martin
Address 138772 0
Black Dog Institute, University of New South Wales, Sydney Hospital Rd, Randwick NSW 2031 Australia
Country 138772 0
Australia
Phone 138772 0
+61 2 9348 0183
Fax 138772 0
Email 138772 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This will not be available as per the conditions of our ethical approval.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.