Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001291673
Ethics application status
Approved
Date submitted
17/11/2023
Date registered
12/12/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
12/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Impact of Digital Cognitive Behavioural Therapy for Insomnia on Depression Symptoms and Processes in Young Adults.
Scientific title
Assessing the Impact of Digital Cognitive Behavioural Therapy for Insomnia on Depression Symptoms and Processes in Young Adults.
Secondary ID [1] 310983 0
Nil
Universal Trial Number (UTN)
U1111-1300-1169
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 332083 0
Condition category
Condition code
Mental Health 328806 328806 0 0
Depression
Mental Health 328931 328931 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Digital Cognitive Behavioural Therapy for Insomnia (Digital CBTI).

Rationale: Digital CBTI (i.e., CBTI delivered in a digital format) is a well validated treatment for Insomnia. CBTI programs are known to effectively reduce symptoms of depression without directly targeting non-sleep symptoms. However, the mechanisms which underlie the association between improvement in insomnia and improvements in depression are not well understood. Many candidate mechanisms have been proposed (e.g., cognitive biases), yet, there is a lack of research which investigates these possible mechanisms, and data from treatment studies is greatly needed to investigate the causal role of these mechanisms in the association between insomnia and depression.

Type: Non-drug, online, interactive

Setting/location: Online, any location in Australia

Duration: 5 x 20 minute online sessions, delivered over 5 consecutive weeks

Protocol: This program is based on CBTI, the recommended treatment for insomnia (e.g. Qaseem et al., 2016, Ann Intern Med, DOI: 10.7326/M15-2175). It is based on a digitised version of a brief CBTI protocol described in a scientific article in the Australian Journal of General Practice (Sweetman et al., 2021, AJGP, doi: 10.31128/AJGP-04-20-5391).

Content: Each session will be administered online (computer or mobile phone). Each session will contain videos, text, and images. Participants will be asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants will receive tailored therapy recommendations (e.g., prescribed time in bed) during each weekly session, determined by an in-built algorithm and participants' entered data (see Sweetman et al., 2021, Aus J General Practice for tailored therapy recommendations). Immediately after each session is completed, participants will receive an automated follow-up email with session-specific 'follow-up' information and tailored therapy recommendations including recommended bedtime window (approximate reading time: 15 minutes). Participants will receive another automated email one week later with a link to start each subsequent session. Videos are presented by researchers, psychologists, and sleep technicians, each with extensive experience (>8 years) in the management of insomnia.

Tailoring / personalisation: Therapy recommendations will be tailored to participant's insomnia symptoms at baseline and weekly changes in symptoms throughout the program. Bedtime Restriction Therapy (initial restriction of time in bed to consolidate sleep, and subsequent gradual extension of time in bed) is a core component of CBTI. Bedtime restriction recommendations will be tailored to the specific sleep/wake information that participants provide.

Primary therapeutic components: Psychoeducation about sleep, Bedtime restriction therapy, Stimulus Control Therapy, Relaxation Therapy, Cognitive Refocusing, Relapse Prevention.

Adherence assessment: Adherence will be defined as the number of participants commencing each of the 5 online sessions. This information is automatically collected through the online system.
Intervention code [1] 327422 0
Treatment: Other
Intervention code [2] 327423 0
Behaviour
Comparator / control treatment
Waitlist control for 8 weeks before commencing digital CBTI.

Participants in the waitlist condition will receive weekly emails with written information about insomnia and sleep health for the first 5 weeks of the trial. This includes information about;

- 'sleep hygiene' (healthy sleep behaviours)

- sleep myths and facts

- Information about caffeine and sleep

- depression and sleep

- chronic insomnia (symptoms, diagnosis, treatment options)

Each weekly information packet takes approximately 4 minutes to read and is sourced from the Sleep Health Foundation.
Control group
Active

Outcomes
Primary outcome [1] 336608 0
Between-group change in self-reported depression symptoms on the Patient Health Questionnaire (PHQ-9).
Timepoint [1] 336608 0
Between-group change in PHQ-9 scores from baseline to 8-week follow-up post-randomisation (primary timepoint).

Change in PHQ-9 scores from baseline to 16-week and 24-week follow-up.
Secondary outcome [1] 428963 0
Between-group change in self-reported insomnia severity.
Timepoint [1] 428963 0
Between-group change in ISI scores from baseline to 8-week follow-up post-randomisation.

Change in ISI from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [2] 428993 0
Between-group change in self-reported anxiety symptoms on the Generalised Anxiety Disorder Questionnaire-7 (GAD-7).
Timepoint [2] 428993 0
Between-group change in GAD-7 scores from baseline to 8-week follow-up post-randomisation.

Change in GAD-7 scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [3] 428994 0
Between-group change in self-reported approach-related behaviour on the Behavioural Inhibition System and Behavioural Activation System Scales (BIS/BAS)
Timepoint [3] 428994 0
Between-group change in BAS scores from baseline to 8-week follow-up post-randomisation.

Change in BAS scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [4] 428995 0
Between-group change in self-reported emotion regulation ability on the Perth Emotion Regulation Competency Inventory (PERCI)
Timepoint [4] 428995 0
Between-group change in PERCI scores from baseline to 8-week follow-up post-randomisation.

Change in PERCI scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [5] 428996 0
Between-group change in self-reported emotion reactivity on the Perth Emotional Reactivity Scale Short-Form (PERS-S).
Timepoint [5] 428996 0
Between-group change in PERS-S scores from baseline to 8-week follow-up post-randomisation.

Change in PERS-S scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [6] 428997 0
Between-group change in self-reported emotion expressivity on the Emotional Expressivity Scale (EES).
Timepoint [6] 428997 0
Between-group change in EES scores from baseline to 8-week follow-up post-randomisation.

Change in EES scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [7] 428998 0
Between-group change in self-reported repetitive negative thinking on the Persistent and Intrusive Negative Thoughts Scale (PINTS).
Timepoint [7] 428998 0
Between-group change in PINTS scores from baseline to 8-week follow-up post-randomisation.

Change in PINTS scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [8] 428999 0
Between-group change in self-reported friendship, isolation, negative and positive attitudes to solitude on the Perth A-Loneness Scale (PALs).
Timepoint [8] 428999 0
Between-group change in PALs scores from baseline to 8-week follow-up post-randomisation.

Change in PALs scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [9] 429000 0
Between-group change in emotion recognition on a computerised version of the Penn Emotion Recognition-40 test.
Timepoint [9] 429000 0
Between-group change in the Penn Emotion Recognition-40 test from baseline to 8-week follow-up post-randomisation.

Change in the Penn Emotion Recognition-40 test from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [10] 429001 0
Between-group change in executive functioning on a computerised version of the Wisconsin Card Sorting Task (WCST)
Timepoint [10] 429001 0
Between-group change on the WCST from baseline to 8-week follow-up post-randomisation.

Change on the WCST from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [11] 429002 0
Between-group change in working memory on a computerised version of the Digit Span Backwards Task (DSB)
Timepoint [11] 429002 0
Between-group change on the DSB from baseline to 8-week follow-up post-randomisation.

Change on the DSB from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [12] 429003 0
Between-group change in attentional control on a computerised version of the Anti-saccade Task (AS Task)
Timepoint [12] 429003 0
Between-group change on the AS Task from baseline to 8-week follow-up post-randomisation.

Change on the AS Task from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [13] 429004 0
Between-group change in sleep-related and depression-related attention bias on a computerised Dual-Probe Attention-Bias task.
Timepoint [13] 429004 0
Between-group change on the Dual-Probe Attention-Bias Task from baseline to 8-week follow-up post-randomisation.

Change on the Dual-Probe Attention-Bias Task from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [14] 429005 0
Between-group change in sleep-related and depression-related interpretation bias on an Ambiguous Scenarios Test.
Timepoint [14] 429005 0
Between-group change on an Ambiguous Scenarios Test from baseline to 8-week follow-up post-randomisation.

Change on an Ambiguous Scenarios Test from baseline to 16-week and 24-week follow-up. post-randomisation
Secondary outcome [15] 429497 0
Change in daytime sleepiness.
Timepoint [15] 429497 0
Between-group change in ESS from baseline to 8-week follow-up post-randomisation.

Change in ESS from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [16] 429498 0
Change in fatigue.
Timepoint [16] 429498 0
Between-group change FFS from baseline to 8-week follow-up post-randomisation.

Change in FFS from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [17] 429499 0
Change in Dysfunctional Beliefs about Sleep
Timepoint [17] 429499 0
Between-group change in DBAS-16 scores from baseline to 8-week follow-up post-randomisation.

Change in DBAS-16 scores from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [18] 429500 0
Change in self-reported sleep.
Timepoint [18] 429500 0
Between-group change in Sleep Diary metrics from baseline to 8-week follow-up post-randomisation.

Change in Sleep Diary metrics from baseline to 16-week and 24-week follow-up post-randomisation.
Secondary outcome [19] 429501 0
Between-group change in self-reported withdrawal-related behaviour on the Behavioural Inhibition System and Behavioural Activation System Scales (BIS/BAS)
Timepoint [19] 429501 0
Between-group change in BIS scores from baseline to 8-week follow-up post-randomisation.

Change in BIS scores from baseline to 16-week and 24-week follow-up post-randomisation.

Eligibility
Key inclusion criteria
Young adults aged 18 – 24 years.

PHQ-9 score of 10 or above (i.e., moderate depression symptoms)

Reliable access to computer, tablet or smartphone, with internet access

Basic English language comprehension as required for digital CBTI program
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychiatric condition (Bipolar disorder, schizophrenia)

Epilepsy

Currently pregnant

Moderate daytime sleepiness (Epworth Sleepiness Scale score equal to or more than 16)

People who are commercial drivers or operate heavy machinery for work

People with a cognitive impairment

Shift workers

Previous diagnosis of a narcolepsy or REM sleep disorder

Previous sleepiness-related motor-vehicle accident

In all cases where individuals are excluded from the study, an appropriate onward referral will be made.

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)
Computer generated block randomisation, with block sizes of 2 and 4. 
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To detect small-to-moderate (f=0.175) between group effects between the two groups from pre-treatment to the 8 week follow-up, a minimum of 196 participants need to be recruited. Therefore, approximately 200 participants will be recruited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
6/03/2024
Date of last participant enrolment
Anticipated
1/02/2029
Actual
Date of last data collection
Anticipated
1/08/2029
Actual
Sample size
Target
200
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315242 0
University
Name [1] 315242 0
University of Western Australia
Country [1] 315242 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 317281 0
None
Name [1] 317281 0
Address [1] 317281 0
Country [1] 317281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314165 0
UWA Human Research Ethics Committee
Ethics committee address [1] 314165 0
Ethics committee country [1] 314165 0
Australia
Date submitted for ethics approval [1] 314165 0
30/03/2023
Approval date [1] 314165 0
11/07/2023
Ethics approval number [1] 314165 0
2023/ET000230

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

Contacts
Principal investigator
Name 130646 0
Dr Cele Richardson
Address 130646 0
University of Western Australia, 35 Stirling Highway Crawley WA 6009
Country 130646 0
Australia
Phone 130646 0
+61 8 6488 3141
Fax 130646 0
Email 130646 0
cele.richardson@uwa.edu.au
Contact person for public queries
Name 130647 0
Cele Richardson
Address 130647 0
University of Western Australia, 35 Stirling Highway Crawley WA 6009
Country 130647 0
Australia
Phone 130647 0
+61 8 6488 3141
Fax 130647 0
Email 130647 0
cele.richardson@uwa.edu.au
Contact person for scientific queries
Name 130648 0
Cele Richardson
Address 130648 0
University of Western Australia 35 Stirling Highway Crawley WA 6009
Country 130648 0
Australia
Phone 130648 0
+61 8 6488 3141
Fax 130648 0
Email 130648 0
cele.richardson@uwa.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?
Data will be shared after de-identification only. Participant data of published results and other available data will be shared upon reasonable request.
When will data be available (start and end dates)?
Data will be made available following publication of outcomes, and will remain available as long as data is stored (in compliance with retention policies).
Available to whom?
Only research who provide a methodologically sound proposal will have access to the data.
Available for what types of analyses?
Methodologically sound projects and meta-analysis
How or where can data be obtained?
By contacting the principle investigator at cele.richardson@uwa.edu.au


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.