Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001141235
Ethics application status
Approved
Date submitted
20/06/2018
Date registered
11/07/2018
Date last updated
15/02/2022
Date data sharing statement initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet cognitive behavioural therapy for insomnia versus internet cognitive behavioural therapy for anxiety in a comorbid sample
Scientific title
A comparison of internet-based cognitive behavioural therapy for insomnia versus internet-based cognitive behavioural therapy for anxiety in a comorbid sample
Secondary ID [1] 295265 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia
 308444 0
anxiety 308580 0
depression 308581 0
Condition category
Condition code
Mental Health 307424 307424 0 0
Anxiety
Mental Health 307425 307425 0 0
Depression
Mental Health 307426 307426 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants that apply for the study will be randomised in equal proportions to one of two active treatment groups:
1. Internet cognitive behavioural therapy for insomnia (iCBT-I)
2. Internet cognitive behavioural therapy for anxiety (iCBT-A)

iCBT-I
Group 1 will receive the online insomnia CBT program (iCBT-I), which is a 4-lesson program that includes psycho-education about insomnia and how it is maintained, as well as specific strategies to manage insomnia (e.g., changing unhelpful behaviours, managing worries about sleep and catastrophic thinking about the consequences of poor sleep, and monitoring sleep schedules). The program comprises online lessons/modules, supplemented with homework activities to complete between lessons to consolidate the key skills taught in the program. In addition, this program includes a sleep diary for participants to keep track of their sleep schedules and monitor progress throughout the program.

iCBT-A
Group 2 will receive the online anxiety CBT program (iCBT-A), which is a 4-lesson program including psycho-education about anxiety and how it is maintained, and specific anxiety management strategies including relaxation (controlled breathing), cognitive therapy techniques to challenge worries and catastrophic thinking styles, and graded exposure to overcome behavioural avoidance and safety behaviours that maintain anxiety. Similar to the insomnia program. The program comprises online lessons/modules, supplemented with homework activities to complete between lessons to consolidate the key skills taught in the program.

The groups will be matched on the length, style, and format, but the key differences will be the content of the program, and targeted symptoms (i.e., insomnia or anxiety). Both groups will have access to the 4 online lessons for up to 8 weeks, and will be encouraged to complete one lesson every 5-10 days. Each lesson is estimated to take 3-4 hours, including lesson slides and homework activities over the week. Homework activities build on the skills taught in the lesson slides, including stimulus control exercises, creating a wind down routine, and relaxation (for the iCBT-I group) and thought challenging, problem solving, and exposure step ladders (for the iCBT-A group). Adherence to the program is assessed by how many lessons a participant completes, where a lesson is marked as complete when the homework activities for that lesson are downloaded.
Intervention code [1] 301600 0
Treatment: Other
Intervention code [2] 301601 0
Behaviour
Comparator / control treatment
COMPARATOR GROUP: cognitive behavioural therapy for anxiety (iCBT-A). These participants will complete the same sets of questionnaires and number of program sessions as the iCBT-I condition.
Control group
Active

Outcomes
Primary outcome [1] 306395 0
Insomnia Severity Index (ISI; Morin, 1993) - a brief self-report instrument measuring the symptoms of insomnia.
Timepoint [1] 306395 0
Immediately pre-treatment, mid-treatment (before lesson 3), post-treatment (primary endpoint; 1 week after the final lesson), and 3-month follow-up (3-months after the completion of the post-treatment questionnaires).
Primary outcome [2] 306396 0
Generalized Anxiety Disorder 7-point Scale (GAD-7; Spitzer et al., 2006) – a validated measure to assess generalized anxiety symptoms.
Timepoint [2] 306396 0
Immediately pre-treatment, mid-treatment (before lesson 3), post-treatment (primary endpoint; 1 week after the final lesson), and 3-month follow-up (3-months after the completion of the post-treatment questionnaires).
Secondary outcome [1] 348344 0
Patient Health Questionnaire 9-item version (PHQ-9; Kroenke et al., 2001) – a validated measure of depressive symptoms.
Timepoint [1] 348344 0
Immediately pre-treatment, mid-treatment (before lesson 3), post-treatment, and 3-month follow-up (3-months after the completion of the post-treatment questionnaires).
Secondary outcome [2] 348345 0
Kessler-10 (K10; Kessler et al., 2002) –a validated measure of general psychological distress.
Timepoint [2] 348345 0
Immediately pre-treatment, mid-treatment (before lesson 3), post-treatment, and 3-month follow-up (3-months after the completion of the post-treatment questionnaires)..
Secondary outcome [3] 348346 0
Sleep parameters based on sleep diary input from participant (composite outcomes including sleep onset latency, sleep efficiency, time spent in bed).
Timepoint [3] 348346 0
Immediately pre-treatment and immediately post-treatment once daily for two weeks.
Secondary outcome [4] 348734 0
Dysfunctional Beliefs and Attitudes about Sleep (DBAS; Morin, 1994) – a validated measure of an individual’s beliefs and attitudes about sleep.
Timepoint [4] 348734 0
Immediately pre-treatment, mid treatment (before lesson 3), post-treatment (1 week after the final lesson), and 3-month follow-up (3-months after the completion of the post-treatment questionnaires).
Secondary outcome [5] 365548 0
Repetitive Thinking Questionnaire (RTQ: McEvoy et al., 2010) - a validated mesaure to assess the frequency of negative repetitive thinking.
Timepoint [5] 365548 0
Immediately pre-treatment, mid-treatment (before Lesson 3), post treatment and 3 month follow-up.
Secondary outcome [6] 365549 0
Pre-Sleep Arousal Scale (PSAS: Nicassio et al., 1995) - a validated instrument to assess cognitive arousal related to worry.
Timepoint [6] 365549 0
Immediately pre-treatment, mid-point (prior to Lesson 3), post-treatment, and 3 month follow-up.
Secondary outcome [7] 365550 0
APS - measure of common behaiours and self-perceptions.
Timepoint [7] 365550 0
Immediately prior to treatment, mid-point (Lesson 3), post-treatment, and 3 month follow-up.
Secondary outcome [8] 365551 0
Glasgow Sleep Effort Scale (GSES; Broomfield & Espie, 2003) - a validated measure of sleep effort during night-time sleep patterns.
Timepoint [8] 365551 0
Immediately prior to treatment, mid-point (prior to Lesson 3), post-treatment, 3 month follow-up.
Secondary outcome [9] 365552 0
Acceptability of the intervention: Change scores from baseline on the Credibility/Expectancy Questionnaire (CEQ) and Treatment Satisfaction Questionnaire (TSQ)
Timepoint [9] 365552 0
Post-treatment

Eligibility
Key inclusion criteria
Individuals aged over 18 years old with online questionnaire scores indicating a clinical level of anxiety on the GAD-7 (> 9) and insomnia on the ISI (> 14).

Participants must be prepared to provide their own name, phone number and address, and details of their general practitioner (GP). Participants are also required to have English language skills equivalent to a School Certificate level, access to a phone and computer with a printer, and must provide electronic informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mental health exclusion criteria will include self-reported diagnosis of psychosis, bipolar disorder, substance abuse or dependence, current PTSD, severe depression (PHQ-9 >23), current suicidality, and/or a PHQ-9 Item 9 score above 1, and/or BDI Item 9 score above 1. Additional exclusion criteria will include presence of untreated sleep disorder other than insomnia, engagement in shift work/presence of commitments that interfere with regular night-time sleep patterns, bed times outside of 8pm-2am more than twice a week not primarily due to insomnia, previous participation in a This Way Up course for insomnia or anxiety, and changes in/initiation of psychological or pharmacological treatment in the previous 2 months to application. Participants who do not complete 7 sleep diaries within a 10-day period will not be eligible to participate.

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)
Patients who meet inclusion criteria for the study will be randomly allocated to one of the two groups (Group 1 iCBT-I; Group 2 iCBT-A).
Allocation concealment will occur in the following way: participants will be randomly allocated to each group via the virtualclinic software, without research staff member involvement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation generated via software
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
In a related study, which compared iCBT for insomnia to iCBT for depression in a co-morbid sample, the between group effect size was 0.6 (Blom et al., 2015). An n of 44 per group is required to detect an effect size of this magnitude. Given predicted attrition, we will recruit a total sample of 100 participants (N=100).

All analyses will be undertaken using intention to treat mixed model and linear analyses. Relationships between observations at different occasions will be modelled with the appropriate covariance matrix. Planned contrasts will be used to compare changes between pre-treatment and post-treatment, and 3-month follow-up. Planned pairwise comparisons will be used to compare between-groups at post-treatment and follow-up, and effect sizes will be calculated (Hedges g) to measure the size of the between-group difference on primary and secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2019
Actual
11/03/2019
Date of last participant enrolment
Anticipated
1/06/2020
Actual
22/06/2020
Date of last data collection
Anticipated
24/12/2020
Actual
14/01/2021
Sample size
Target
100
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 11201 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 23063 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299853 0
Hospital
Name [1] 299853 0
St Vincent's Hospital, Sydney
Country [1] 299853 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 299207 0
None
Name [1] 299207 0
Address [1] 299207 0
Country [1] 299207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300729 0
St Vincent's Hospital Research Ethics Committee [EC00140]
Ethics committee address [1] 300729 0
Ethics committee country [1] 300729 0
Australia
Date submitted for ethics approval [1] 300729 0
15/05/2018
Approval date [1] 300729 0
23/10/2018
Ethics approval number [1] 300729 0
2018/ETH00086

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

Contacts
Principal investigator
Name 84626 0
Dr Elizabeth Mason
Address 84626 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4 The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 84626 0
Australia
Phone 84626 0
+61283821400
Fax 84626 0
Email 84626 0
[email protected]
Contact person for public queries
Name 84627 0
Ashlee Grierson
Address 84627 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4 The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 84627 0
Australia
Phone 84627 0
+61283821400
Fax 84627 0
Email 84627 0
[email protected]
Contact person for scientific queries
Name 84628 0
Ashlee Grierson
Address 84628 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4 The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 84628 0
Australia
Phone 84628 0
+61283821400
Fax 84628 0
Email 84628 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
Have not sought ethical approval for sharing individual patient 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.