Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000415606
Ethics application status
Approved
Date submitted
3/04/2023
Date registered
26/04/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
26/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep Best-i: An online cognitive-behavioural intervention for the treatment of insomnia and nightmares in wildfire survivors
Scientific title
Sleep Best-i: An online cognitive-behavioural intervention for the treatment of insomnia and nightmares in wildfire survivors
Secondary ID [1] 308680 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 328605 0
Post-Traumatic Stress Disorder (PTSD) 328606 0
Nightmares 328607 0
Condition category
Condition code
Mental Health 325616 325616 0 0
Other mental health disorders
Public Health 325617 325617 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleep Best-i is an online self-guided treatment for insomnia, nightmares and PTSD. The intervention consists of 6 modules addressing the following topics: Module 1-Psychoeducation about sleep and insomnia, Module 2- Part 1-Cognitive restructuring and sleep hygiene, Part 2-Sleep scheduling and stimulus control, Module 3- Trauma, PTSD and flashbacks, Module 4- Nightmares, Module 5- Relapse prevention.

The intervention will be offered over a 4 week period and assessments will be carried out at the start of the trial, at week 4 and week 12 of the trial.

Sleep Best-i uses: a) animated videos, cognitive behavioural experiments and role play of therapeutic sessions. b) participants will be offered weekly modules (17 minutes in duration to watch at their own pace) over a 4-week period. On week 1 and week 4, participants will be given 2 modules instead of one module as they are related to the same topic. c) Adherence to Sleep Best-i will be monitored via participants' sign up on to platform and also through an assessment administered on week 4.

Method of allocation of participants to intervention and waitlist groups is alternating the first participants to intervention, the second to waitlist, third to intervention, fourth to waitlist and so on.
Intervention code [1] 325149 0
Behaviour
Intervention code [2] 325811 0
Treatment: Other
Comparator / control treatment
Wait-list group will be offered the same treatment as the intervention group after the 4-week intervention period. During the wait period, the waitlist group will receive "No treatment"
Control group
Active

Outcomes
Primary outcome [1] 333460 0
Insomnia assessed using the Insomnia Severity Index
Timepoint [1] 333460 0
For the intervention group, participants will complete a pre-assessment one week prior to the intervention, at week 4 end of treatment and week 12 follow-up post intervention.
For the primary outcomes, participants in the intervention group will complete the ISI one week prior to treatment, at week 4 post treatment and at week 12 follow -up post treatment.

For the waitlist group, participants will complete a pre-assessment at the very start of the trial, at one week prior to receiving intervention, at week 4 end of treatment and week 12 follow-up post intervention.

For the primary outcomes, participants in the waitlist group will complete the ISI at the beginning of the trial, at one week prior to receiving the treatment, at week 4 post treatment and at week 12 follow -up post treatment.
Primary outcome [2] 333461 0
Nightmares assessed using the Nightmare Disorder Index (NDI)
Timepoint [2] 333461 0
For the intervention group, participants will complete a pre-assessment one week prior to the intervention, at week 4 end of treatment and week 12 follow-up post intervention.

For the primary outcomes, participants in the intervention group will complete the NDI one week prior to treatment, at week 4 post treatment and at week 12 follow -up post treatment.

For the waitlist group, participants will complete a pre-assessment at the very start of the trial, at one week prior to receiving intervention, at week 4 end of treatment and week 12 follow-up post intervention.

For the primary outcomes, participants in the waitlist group will complete the NDI at the beginning of the trial, at one week prior to receiving the treatment, at week 4 post treatment and at week 12 follow -up post treatment.
Primary outcome [3] 333462 0
PTSD severity assessed using the PTSD CheckList – Civilian Version (PCL-5),
Timepoint [3] 333462 0
For the intervention group, participants will complete a pre-assessment one week prior to the intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the primary outcomes, participants in the intervention group will complete the PTSD CheckList – Civilian Version (PCL-5) one week prior to treatment, at week 4 post treatment and at week 12 follow -up post treatment. For the waitlist group, participants will complete a pre-assessment at the very start of the trial, at one week prior to receiving intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the primary outcomes, participants in the waitlist group will complete the PTSD CheckList – Civilian Version (PCL-5) the beginning of the trial, at one week prior to receiving the treatment, at week 4 post treatment and at week 12 follow -up post treatment.
Secondary outcome [1] 417157 0
Depression assessed using the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 417157 0
For the intervention group, participants will complete a pre-assessment one week prior to the intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the secondary outcomes, participants in the intervention group will complete the PHQ-9 one week prior to treatment, at week 4 post treatment and at week 12 follow -up post treatment. For the waitlist group, participants will complete a pre-assessment at the very start of the trial, at one week prior to receiving intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the secondary outcomes, participants in the waitlist group will complete the PHQ-9 at the beginning of the trial, at one week prior to receiving the treatment, at week 4 post treatment and at week 12 follow -up post treatment.
Secondary outcome [2] 417158 0
Anxiety assessed using the Generalized Anxiety Disorder 7-item (GAD-7)
Timepoint [2] 417158 0
For the intervention group, participants will complete a pre-assessment one week prior to the intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the secondary outcomes, participants in the intervention group will complete the GAD-7 one week prior to treatment, at week 4 post treatment and at week 12 follow -up post treatment. For the waitlist group, participants will complete a pre-assessment at the very start of the trial, at one week prior to receiving intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the secondary outcomes, participants in the waitlist group will complete the GAD-7 at the beginning of the trial, at one week prior to receiving the treatment, at week 4 post treatment and at week 12 follow -up post treatment.
Secondary outcome [3] 417159 0
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 417159 0
For the intervention group, participants will complete a pre-assessment one week prior to the intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the secondary outcomes, participants in the intervention group will complete the PSQI one week prior to treatment, at week 4 post treatment and at week 12 follow -up post treatment. For the waitlist group, participants will complete a pre-assessment at the very start of the trial, at one week prior to receiving intervention, at week 4 end of treatment and week 12 follow-up post intervention. For the secondary outcomes, participants in the waitlist group will complete the PSQI at the beginning of the trial, at one week prior to receiving the treatment, at week 4 post treatment and at week 12 follow -up post treatment.

Eligibility
Key inclusion criteria
Inclusion criteria:

• Participants have to be wildfire/bushfire survivors

• Participants have to meet clinical cut off points on one of the following scales to be included in the study: (1) The Insomnia Severity Index (ISI, participants have to score 8 or greater to be included in the study), and/or (2) The Nightmare Disorder Index (NDI, participants have to score 3 or greater on the scale to be included in the study), and/or (3) PTSD CheckList – Civilian Version (PCL-5) (participants have to score 31 or greater on the scale to be included in the study)

• Participants who are on antidepressants and sleeping medications will be allowed to participate given that treatment is stable throughout the study

• Males and females aged 18+

• Internet and email access

fluency in the English language


Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

• Not wildfire/bushfire survivors.
• Diagnosis of bipolar or psychotic disorders as assessed by the online questions and/or the clinical interview.
• Suicidal risk if assessed by a clinical interview.
• Unmanaged alcohol or drug abuse in the last 12 months as assessed by the online questions or the clinical interview.
• Previous diagnosis of sleep apnoea or restless legs syndrome.
• Current use of medications that are known to cause insomnia such as steroids.
• Safety concerns (unmanaged physical or mental health issues).
• Attending psychotherapy for sleep or PTSD.

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
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess the effectiveness of Sleep Best-i, a mixed design will be used. A repeated measures t-test statistics (quantitative design using SPSS 26) will be used on the data collected before and after the treatment to compare the effectiveness of the treatment.

Participants will also provide their feedback on Sleep Best-i at week 2, week 3 and week 4, Inductive thematic analysis will be performed on the feedback collected and themes will be extracted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2023
Actual
1/05/2023
Date of last participant enrolment
Anticipated
3/11/2023
Actual
9/12/2023
Date of last data collection
Anticipated
3/02/2024
Actual
19/02/2024
Sample size
Target
50
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25192 0
Canada
State/province [1] 25192 0
British Columbia
Country [2] 25193 0
United States of America
State/province [2] 25193 0
California

Funding & Sponsors
Funding source category [1] 312744 0
University
Name [1] 312744 0
Federation University
Country [1] 312744 0
Australia
Primary sponsor type
University
Name
Federation University
Address
PO Box 663
Ballarat VIC 3353
Country
Australia
Secondary sponsor category [1] 314365 0
Government body
Name [1] 314365 0
Natural Hazards Research Australia
Address [1] 314365 0
Building 76, RMIT University, 56 Cardigan St, Carlton South, VIC 3053
Country [1] 314365 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312049 0
Federation University Human Research Ethics Committee
Ethics committee address [1] 312049 0
Ethics committee country [1] 312049 0
Australia
Date submitted for ethics approval [1] 312049 0
Approval date [1] 312049 0
23/08/2022
Ethics approval number [1] 312049 0
2022-153

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

Contacts
Principal investigator
Name 123274 0
Prof Gerard Kennedy
Address 123274 0
Federation University | Office 211 | Building HP | Mt Helen Campus

PO Box 663 Ballarat VIC 3353
Country 123274 0
Australia
Phone 123274 0
+61 3 5327 6651
Fax 123274 0
Email 123274 0
[email protected]
Contact person for public queries
Name 123275 0
Fadia Isaac
Address 123275 0
Federation University | Office 211 | Building HP | Mt Helen Campus

PO Box 663 Ballarat VIC 3353
Country 123275 0
Australia
Phone 123275 0
+61 3 5327 6651
Fax 123275 0
Email 123275 0
[email protected]
Contact person for scientific queries
Name 123276 0
Fadia Isaac
Address 123276 0
Federation University | Office 211 | Building HP | Mt Helen Campus

PO Box 663 Ballarat VIC 3353
Country 123276 0
Australia
Phone 123276 0
+61 3 5327 6651
Fax 123276 0
Email 123276 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
We do not have ethics approval to share related data


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.