Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000639527
Ethics application status
Approved
Date submitted
2/05/2024
Date registered
17/05/2024
Date last updated
26/07/2024
Date data sharing statement initially provided
17/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mental images of suicide imagery rescripting study
Scientific title
Imagery rescripting of mental images of suicide, a feasibility study of young people aged 16-25 years
Secondary ID [1] 311814 0
None
Universal Trial Number (UTN)
Trial acronym
MISO-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 333335 0
Suicide 333337 0
mental health 333692 0
Condition category
Condition code
Mental Health 330024 330024 0 0
Depression
Mental Health 330432 330432 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test the acceptability, feasibility and safety of a novel intervention (Imagery Rescripting) in a small pilot study of 25 young people with mood disorders and suicidal ideation from the Youth Mood Clinic (YMC), at Orygen Specialist Programs. Young people with Depression will receive Imagery Rescripting treatment following the study protocol for treating mental images of suicide in youth with mood disorders.
Study clinicians are experienced psychologists in the YMC and are trained and supported by an expert in imagery rescripting. Training is comprised of a combination of face-to-face workshops and online videos to support the content. All clinicians are trained at least one month prior to conducting the intervention. Complementing the training is a study intervention manual. Clinicians adhere to the manual which outlines the steps for identifying the image/s to be rescripted and for supportive and safety procedures to scaffold the clinical implementation.
The first clinician session focuses on psychoeducation about mental imagery and mental images of suicide or death, development of safe space imagery (which can be used in later sessions to lower distress if necessary), confirming the selection of an appropriate mental image to rescript and conducting the Suicidal Cognitions and Flashforward Interview.
The next session focuses on rescripting this image. The client and therapist together select the mental image of suicide which will be rescripted. Only current images (experienced in the past two weeks) will be selected for rescripting. It is important to determine whether the image increases risk for suicidal behaviour, or decreases risk for suicidal behaviour (i.e., is protective). Only images that the young person indicates increase risk for suicidal behaviour are the focus of intervention for the current study.
The third session (the second rescripting session) may be omitted if the client is adamant that they do not want to rescript again, or they can choose a second image to rescript (replacing the 4th session).
An optional fourth session can be planned to rescript an additional mental image of death or suicide.
Study participants therefore will receive weekly, face-to-face therapy sessions of 60 minutes duration, between 2-4 sessions in total (session number determined by clinician and patient discussion and response to treatment).
Study clinicians will be supported in adhering to the intervention with fortnightly supervision sessions.
Intervention code [1] 328262 0
Behaviour
Comparator / control treatment
No control group. This is a feasibility and acceptability study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338113 0
Acceptability
Timepoint [1] 338113 0
Final assessment - week 7 post enrolment /conclusion of intervention
Primary outcome [2] 338114 0
Feasibility
Timepoint [2] 338114 0
Conclusion of recruitment period, 2 years
Primary outcome [3] 338115 0
Safety
Timepoint [3] 338115 0
Baseline, each imagery rescripting session (weekly from week 2 up to week 6), Final assessment at Week 7/conclusion of intervention.
Secondary outcome [1] 434570 0
Suicidal ideation
Timepoint [1] 434570 0
Baseline, each imagery rescripting session (weekly as indicated) and at Final assessment week 7 / conclusion of the intervention.
Secondary outcome [2] 434847 0
Symptoms of depression
Timepoint [2] 434847 0
Baseline, each imagery rescripting session (weekly as indicated) and at Final assessment week 7 / conclusion of the intervention.
Secondary outcome [3] 434848 0
Symptoms of anxiety
Timepoint [3] 434848 0
Baseline, each imagery rescripting session (weekly as indicated) and at Final assessment week 7 / conclusion of the intervention.
Secondary outcome [4] 434849 0
Symptoms of mania
Timepoint [4] 434849 0
Baseline, each imagery rescripting session (weekly as indicated) and at Final assessment week 7 / conclusion of the intervention.

Eligibility
Key inclusion criteria
1. Young people aged 16 to 25 inclusive;
2. Current or recent suicidal ideation (within last 4 weeks);
3. Engagement with Orygen Specialist Program’s Youth Mood Clinic treatment as determined by the treating clinician;
4. Familiarity with, and willingness to use available crisis supports in context of suicide risk determined by patient report and clinical information;
5. Ability to provide informed consent and comply with study procedures;
6. Willingness to nominate an emergency contact;
7. Reporting one or more mental images of suicide, which increases risk for suicide, in the past 14 days;
8. Willingness to dedicate two treatment sessions to imagery rescripting therapy to treat the suicidal mental image (with an optional third and fourth session).
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of an intellectual disability as documented on their medical record;
2. Not able to converse in, or read in English;
3. Poorly engaged in face-to-face treatment or approaching discharge as determined by the treating clinician;
4. Currently at acute risk of suicide requiring acute risk management;
5. Actively manic or psychotic (assessed by treating clinician) as assessed by the treating clinician;
6. Active mania or psychosis as assessed by the treating clinician;
7. Has not experienced mental images of suicide;
8. Presence of organic brain disease or severe neurological impairment, as documented in medical record;
9. Experience of only mental image(s) of suicide which decreases the risk of suicidal behaviour (i.e. a protective image) as reported by participant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/06/2023
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
15/01/2025
Actual
Sample size
Target
25
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316151 0
Charities/Societies/Foundations
Name [1] 316151 0
Suicide Prevention Australia
Country [1] 316151 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
Country
Australia
Secondary sponsor category [1] 318330 0
None
Name [1] 318330 0
Address [1] 318330 0
Country [1] 318330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314980 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314980 0
Ethics committee country [1] 314980 0
Australia
Date submitted for ethics approval [1] 314980 0
21/04/2022
Approval date [1] 314980 0
30/11/2022
Ethics approval number [1] 314980 0
2022.042RMH82363

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

Contacts
Principal investigator
Name 133306 0
Prof Lianne Schmaal
Address 133306 0
Orygen, 35 Poplar Road, Parkville VIC 3052
Country 133306 0
Australia
Phone 133306 0
+61 3 9966 9524
Fax 133306 0
Email 133306 0
lianne.schmaal@orygen.org.au
Contact person for public queries
Name 133307 0
Ms Connie Markulev
Address 133307 0
Orygen, 35 Poplar Road, Parkville VIC 3052
Country 133307 0
Australia
Phone 133307 0
+61 399669100
Fax 133307 0
Email 133307 0
connie.markulev@orygen.org.au
Contact person for scientific queries
Name 133308 0
Prof Lianne Schmaal
Address 133308 0
Orygen, 35 Poplar Road, Parkville VIC 3052
Country 133308 0
Australia
Phone 133308 0
+61 399669100
Fax 133308 0
Email 133308 0
lianne.schmaal@orygen.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data, anonymised.
When will data be available (start and end dates)?
Data are currently embargoed. They will be available after the main results have been published for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal.
Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis.
Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ANZCTRN number in the catalogue to find datasets associated with this trial.


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.