Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000337572
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
26/03/2024
Date last updated
25/07/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Project SAIL: Supporting Adolescents in Loss.
Scientific title
Unguided internet cognitive behaviour therapy for grief in adolescents.
Secondary ID [1] 311569 0
Project SAIL
Universal Trial Number (UTN)
Trial acronym
SAIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grief 332940 0
Anxiety 332942 0
Depression 332943 0
Condition category
Condition code
Mental Health 329655 329655 0 0
Other mental health disorders
Mental Health 329657 329657 0 0
Anxiety
Mental Health 329658 329658 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All changes to interventions were completed prior to data collection.

A co-designed internet intervention for grief, of 8 modules over 4 weeks aims to reduce symptoms of anxiety, depression, prolonged grief and post-traumatic stress-disorder and improve well-being in adolescents aged 13-18 years residing in Australia.

The 8 modules were chosen to be a brief, but also with enough material to improve wellbeing. The modules will include psychoeducation about grief and mental health, reframing loss, challenging self-blame and increasing pleasant events to improve mood.

Content:
The eight modules in the online grief intervention include; 1) psychoeducation about normalising grief and loss, 2) cognitive formulation of maintaining processes, 3) behavioural activation, improving self-care (eating/sleeping routines), and cognitive strategies of responsibility pie charts to challenge self-blame, 4) cognitive strategies through behavioural experiments to challenge negative thinking and predictions, 5) thought records and continuums to challenge all or nothing thinking and other negative thinking styles, 6) exposure to avoid triggers, memories, and mages including writing a letter, 7) imagery rescripting and memory updating, and problem solving, and 8) relapse prevention.

Each module contains between 6 to 9 webpages, and completing two modules per week over four weeks will be suggested. Each module is predicted to take between 30 and 60 minutes.

Outcomes.
We will assess anxiety, depression, wellbeing, grief and post-traumatic stress disorder through self-report questionnaires. Participants will be screened online prior to acceptance into the trial for the intervention, those with high suicide risk will not be accepted into the trial and will be referred elsewhere.
Intervention code [1] 328023 0
Treatment: Other
Intervention code [2] 328159 0
Treatment: Other
Intervention code [3] 328160 0
Behaviour
Comparator / control treatment
There will be 64 participants in total, 32 who receive immediate treatment and 32 randomised to 4 week wait-list control. The wait-list control participants will not receive any intervention during the 4 weeks but will be offered the intervention at the end of the wait-list period.
Control group
Active

Outcomes
Primary outcome [1] 337443 0
Depression
Timepoint [1] 337443 0
Administered online at pre-intervention, immediately post-intervention, and four-week follow-up compared to wait-list control.
Primary outcome [2] 337444 0
Anxiety
Timepoint [2] 337444 0
Administered online at pre-intervention, immediately post-intervention and four-week follow-up compared to wait-list control.
Secondary outcome [1] 431875 0
Well-being.
Timepoint [1] 431875 0
Administered online at pre-intervention, immediately post-intervention and four-week follow-up compared to wait-list control.
Secondary outcome [2] 432582 0
Acceptability of the intervention.
Timepoint [2] 432582 0
The online questions will be administered immediately post-intervention, the semi-structured interview will be conducted on MS Teams within 2 weeks of treatment completion.
Secondary outcome [3] 433115 0
Grief
Timepoint [3] 433115 0
Administered online at pre-intervention, immediately post-intervention and four-week follow-up compared to wait-list control.
Secondary outcome [4] 433116 0
Post-Traumatic Stress Disorder
Timepoint [4] 433116 0
Administered online at pre-intervention, immediately post-intervention, and four-week follow-up compared to wait-list control.
Secondary outcome [5] 433221 0
Feasibility
Timepoint [5] 433221 0
Baseline time 1 assessment at pre-intervention and post-intervention time 2 assessment, immediately after the intervention.

Eligibility
Key inclusion criteria
(1) age 13-17 years, (2) residing in Australia, (3) a self-reported experience of grief or loss.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criterion is high suicide risk on the Columbia Suicide Screening Scale.

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)
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of adolescents (n = 64 in total, with n = 32 intervention, n = 32 control) is based on the recommendations of Hedecker et al. (1999) for power analysis with longitudinal designs, with three timepoints (pre, post, follow-up), p = .05, power = .80, and an attrition rate of 25%. The research outcomes we predict for the intervention study is that the intervention group will have significantly lower scores compared to waitlist control on outcomes of symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) and significantly higher wellbeing scores. These outcomes will be analysed through Generalised Linear Mixed Modelling (GLMM) in SPSS. Clinical significance analysis will also be used to assess for outcomes on prolonged grief and any negative effects of the intervention i.e., a clinically significant deterioration at post-intervention from pre-intervention scores on symptoms of anxiety, depression and/or PTSD. We also predict that there will be high acceptability through positive feedback on post-intervention online open-ended ended questions and a semi-structured interview. Acceptability will be assessed via qualitative techniques of conventional content analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/03/2024
Actual
26/03/2024
Date of last participant enrolment
Anticipated
3/06/2024
Actual
4/05/2024
Date of last data collection
Anticipated
30/06/2024
Actual
1/07/2024
Sample size
Target
64
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315870 0
Charities/Societies/Foundations
Name [1] 315870 0
Channel 7 Telethon Trust
Country [1] 315870 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 318297 0
Charities/Societies/Foundations
Name [1] 318297 0
Grief Australia
Address [1] 318297 0
Country [1] 318297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314718 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 314718 0
Ethics committee country [1] 314718 0
Australia
Date submitted for ethics approval [1] 314718 0
21/12/2023
Approval date [1] 314718 0
26/02/2024
Ethics approval number [1] 314718 0
HRE2024-0722

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

Contacts
Principal investigator
Name 132506 0
Prof Sarah Egan
Address 132506 0
Curtin University, 208 Kent Street, Bentley WA 6102
Country 132506 0
Australia
Phone 132506 0
+61 8 9266 9266
Fax 132506 0
Email 132506 0
[email protected]
Contact person for public queries
Name 132507 0
Sarah Egan
Address 132507 0
Curtin University, 208 Kent Street, Bentley WA 6102
Country 132507 0
Australia
Phone 132507 0
+61 8 9266 9266
Fax 132507 0
Email 132507 0
[email protected]
Contact person for scientific queries
Name 132508 0
Sarah Egan
Address 132508 0
Curtin University, 208 Kent Street, Bentley WA 6102
Country 132508 0
Australia
Phone 132508 0
+61 8 9266 9266
Fax 132508 0
Email 132508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21915Study protocol  [email protected]
21916Informed consent form  [email protected]
21917Ethical approval  [email protected]
21918Statistical analysis plan  [email protected]



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.