Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000590662
Ethics application status
Approved
Date submitted
18/05/2023
Date registered
30/05/2023
Date last updated
21/06/2024
Date data sharing statement initially provided
30/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Single Session Intervention Helping Young Adults Cope with Strong Negative Emotions
Scientific title
The Efficacy of An Online Single Session Intervention Helping Young Adults Cope with Strong Negative Emotions on the Incidence of Self-Injurious Behaviour: A Randomised Control Trial
Secondary ID [1] 309681 0
None
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 330049 0
Depression 330050 0
Suicidal Ideation 330051 0
Self-harm 330140 0
Condition category
Condition code
Mental Health 326953 326953 0 0
Suicide
Mental Health 326954 326954 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive one of two brief 30-minute online single session interventions delivered through the Qualtrics survey software in a Power Point format. Participants will be able to engage with psychoeducational material by engaging in written activities, self-reflection exercises and providing their own feedback and sharing their experiences.
Participants in the intervention group will receive Project SAVE (Stopping Adolescent Violence Everywhere; Dobias et al., 2021) intervention, which focuses on normalising and de-stigmatising feelings of self hatred wit the aim of empowering young adults to select alternative coping strategies in the face of self-hatred. Alternative coping strategies discussed include Dialectical Behavioural Therapy (DBT) distress tolerance skills.
Participants adherence to the intervention will be monitored using website analytics, which will be derived from the Qualtrics software.
Intervention code [1] 326125 0
Treatment: Other
Comparator / control treatment
Participants in the active control group will also participate in a 30-minute online single session intervention delivered through the Qualtrics survey software in a Power Point format. Participants will receive the "Share your Feelings" intervention, which uses components of supportive therapy to encourage feelings sharing.
Control group
Active

Outcomes
Primary outcome [1] 334788 0
Change in the likelihood of future non-suicidal self-injurious behaviour measured by the Self-Injurious Thoughts and Behaviours Interview - Revised (Fox et al., 2020)
Timepoint [1] 334788 0
Baseline to end of treatment (at the end of the power point)
Primary outcome [2] 334789 0
Change in the frequency of non-suicidal self-injurious thoughts and behaviours measured by the Self-Injurious Thoughts and Behaviours Interview-Revised (Fox et al., 2020)
Timepoint [2] 334789 0
Baseline to 1-month follow-up
Primary outcome [3] 334790 0
Change in State Hope, measured by the State Hope Scale (Snyder et al., 1995), will be assessed.
Timepoint [3] 334790 0
Baseline to end of treatment (at the end of the powerpoint)
Secondary outcome [1] 422099 0
Depression, Anxiety and Stress measured by the Depression, Anxiety and Stress Scales (DASS; Lovibond & Lovibond, 1995);
Timepoint [1] 422099 0
Baseline to 1-month follow-up
Secondary outcome [2] 422354 0
Eating Disorder psychopathology measured by the 7-item Eating Disorder Examination Questionnaire (Grilo et al., 2015
Timepoint [2] 422354 0
Baseline to 1-month follow-up
Secondary outcome [3] 422355 0
Self-criticism/self-hatred will be assessed using the 22-item Forms of Self-Criticising/Attacking &Self-Reassuring Scale (FSCRS; Gilbert et al., 2004)
Timepoint [3] 422355 0
Baseline to 1-month follow-up
Secondary outcome [4] 422356 0
quality of life will be measured using the 12-item Assessment of Quality-of-Life 4D (AQoL 4-D; Richardson & Hawthorne, 1997)
Timepoint [4] 422356 0
Baseline to 1-month follow-up
Secondary outcome [5] 422357 0
health care utilization will be assessed using an adaptation of questions from the Treatment Inventory of Costs in Patients with psychiatric disorders Questionnaire (TIC-P; Bouwmans, et al., 2013).
Timepoint [5] 422357 0
Baseline to 1-month follow-up

Eligibility
Key inclusion criteria
Inclusion criteria include being aged 18-25, endorsing past month non-suicidal self-injurious (NSSI) thoughts or behaviour
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes suicide attempt in the previous month, diagnosis of bipolar disorder or psychosis. This exclusion criteria were chosen to ensure that the research team can safely manage trial participation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The results of power analysis indicate that to detect an effect size of 0.40 with a 40% attrition rate from post-intervention to 1-month follow-up, a minimum sample size of 82 participants per group would be required, thus a minimum of 164 participants will be recruited. Data will be analysed using linear mixed models (LMM) using the Statistical Package for the Social Sciences Software. LMM will be performed to evaluate between group changes in clinical outcomes from baseline to end of treatment and 1-month follow up. LMM analyses are robust in handling missing data and unbalanced designs in repeated-measures research, (Nich & Carroll, 1997), offering the benefits of estimation maximization (EM), which provides joint linear modelling for each individual for observed and missing data based on maximizing likelihood for population parameters as a function of observed data (Norusis, 2007). Thus, all participants (regardless of missing data at one or more assessment time points) can be included in the data analyses and linear estimates are obtained, as opposed to missing cases being omitted as is the case with traditional ANOVA techniques (Gueorguieva & Krystal, 2004). Time will be entered as a fixed effect in the model

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
1/08/2023
Date of last participant enrolment
Anticipated
20/06/2025
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
164
Accrual to date
72
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313875 0
Charities/Societies/Foundations
Name [1] 313875 0
Breakthrough Mental Health Foundation
Country [1] 313875 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University, Sturt Rd, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 315721 0
None
Name [1] 315721 0
Address [1] 315721 0
Country [1] 315721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313022 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 313022 0
Flinders University, Sturt Road, South Australia, SA 5042
Ethics committee country [1] 313022 0
Australia
Date submitted for ethics approval [1] 313022 0
11/05/2023
Approval date [1] 313022 0
06/07/2023
Ethics approval number [1] 313022 0
Flinders University HREC 6153

Summary
Brief summary
The current randomised control trial (RCT) aims to investigate the impact of a single session online intervention aiming to reduce self-harm cognitions and behaviours in young adults aged 18-25. The online intervention (Project SAVE: Stopping Adolescent Violence Everywhere; Dobias et al., 2021) has been previously evaluated with adolescents in the United States, whereby participants are invited to take part in a 30-minute self-administered psychoeducation intervention presented online using Qualtrics software. The online intervention aims to normalise and de-stigmatise feelings of self-hatred and aims to empower young adults to select alternative coping strategies in the face of self-hatred. Participants are randomised to either receive the project SAVE intervention or an alternative online single session intervention called “Share your feelings”, which is a 30-minute self-administered program that uses components of supportive therapy to encourage feelings sharing (Dobias et al., 2021). The current study aims to expand on previous work conducted with adolescents to investigate the impact of project SAVE on decreasing the frequency and likelihood of non-suicidal self-injurious behaviours in young adults, who either report previous month self-harm behaviours and/or cognitions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126714 0
Miss Marcela Radunz
Address 126714 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 126714 0
Australia
Phone 126714 0
+61882015870
Fax 126714 0
Email 126714 0
marcela.radunz@flinders.edu.au
Contact person for public queries
Name 126715 0
Miss Marcela Radunz
Address 126715 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 126715 0
Australia
Phone 126715 0
+61882015870
Fax 126715 0
Email 126715 0
marcela.radunz@flinders.edu.au
Contact person for scientific queries
Name 126716 0
Miss Marcela Radunz
Address 126716 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 126716 0
Australia
Phone 126716 0
+61882015870
Fax 126716 0
Email 126716 0
marcela.radunz@flinders.edu.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?
The de-identified participant data on the primary and secondary outcomes of this trial will be stored in Open Science platform
When will data be available (start and end dates)?
The data will be available from completion of the trial (i.e., early 2025) and will be stored in the long term in Open Science Platform
Available to whom?
Anyone can access the Open science framework using the link, which will be reported in the peer-reviewed publications reporting on the outcomes of this trial
Available for what types of analyses?
Data will be made available for replication purposes, as well as meta-analytic strategies.
How or where can data be obtained?
The deidentified data will be stored long term on Professor Tracey Wade's Open Science platform: osf.io/rtzv3


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.