Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000637549
Ethics application status
Approved
Date submitted
1/05/2024
Date registered
16/05/2024
Date last updated
1/09/2024
Date data sharing statement initially provided
16/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Cognitive Behavioral Therapy (CBT)-Insomnia be enhanced with clinical-grade, at-home sleep monitoring?: A Pilot study
Scientific title
The feasibility, acceptability, and effectiveness of enhancing CBT for insomnia with a digital platform incorporating home-based EEG and electronic sleep diary: A pilot study in adult participants aged 18-65
Secondary ID [1] 312061 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Insomnia 333670 0
Condition category
Condition code
Mental Health 330358 330358 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
4-8, weekly or fortnightly, 60 minute sessions of individually administered CBT-Insomnia (mostly in person, but telehealth sessions will be provided if required) that will be augmented with the use of a clinical grade, at-home sleep monitoring device (Somfit - see below). Participants can attend sessions weekly or fortnightly depending on convenience and clinical need as discussed with the treating clinician.
Sessions will be held at two clinic urban locations in Perth, Western Australia: one university psychology training clinic, and one private behavioural sleep medicine clinic. Number of sessions will be determined by clinician's discretion of when appropriate CBT-Insomnia material has been delivered.
-Therapy will be administered by clinical psychologists and supervised clinical psychology trainees.
- number of sessions attended and dates of attendance will be recorded.
- within the Somfit-CBT-I software, clinicians can indicate key CBT-Insomnia strategies that they have covered in each session.
-Participation at the university trial site involves no cost to participants. Usual fees apply for participation at the private clinic.
-Participants will be asked to complete questionnaire assessment measures at baseline, post-treatment and 3-month follow-up. These will take approximately 30minutes and include sleep log, Insomnia Severity Index, Depression Anxiety Stress Scales, and the Fatigue Assessment Scale.
-Participants will be asked to wear the Somfit device for 5-7 nights at the above timepoints in order to gain an objective measurement of their sleep.
-clinicians and participants will decide together how frequently to wear the Somfit device during the CBT-Insomnia treatment.


CBT-Insomnia: Description of sessions:
Clinicians can use their discretion in spending more or less time on particular therapy components, or changes in the ordering of content.

Session 1-2
Therapist checks in on the participant’s experience of 7 nights Somfit recording
At each therapist’s discretion and timing, they can share with each participant their sleep recording data.
Assessment of insomnia history and maintaining factors via semi-structured clinical interview
Participant goal setting and motivation for treatment
Sleep education: myths and facts
Regulation of Sleep – Sleep drive; Body clock; Are you an owl or lark?
What is Insomnia?
Strategies for improving sleep by changing behaviour – Wind down before bed; Stimulus control; Winding up
Plan for the week ahead, including completing the sleep diary daily
Therapist to decide whether more sleep studies to be done

Session 2-4:
Imagery exercise
Review plan from last week and sleep diary
Time in bed restriction
Strategies for managing a busy mind vicious cycle of insomnia; Managing negative thoughts;
Review and plan for the week ahead, including completing the sleep diary daily
Therapist to decide whether more sleep studies need to be done

Session 3-5:
Beliefs About Sleep Scale (complete in session)
Mindfulness exercise
Weekly review of plan and sleep diary
Introduction to defusion exercises
Beliefs about sleep
Daytime tiredness
Insomnia cycle for the day
Link between tiredness and sleep
Maximising daytime energy
Review and plan for the week ahead, including completing the sleep diary daily
Therapist to decide whether more sleep studies need to be done

Session 4-6:
Weekly review and sleep diary
Life balance and values
Keeping your progress going: Blueprint for my sleep; Bad night sleep vs a relapse
Planning for setbacks
Review and plan for the future
Encourage continuation of sleep diary if required in follow-up period

Up to 2 additional therapy sessions can be added to consolidate the above content if the participant and therapist agree that this would be helpful for clinical outcomes.


SOMFIT
The Somfit device is not associated with any risk or harm. Somfit is a wearable, low voltage, battery operated device about the size of a 50c piece. Somfit collects signals such as EEG, heart rate, blood oxygen level, movement, body position, light, and noise. The Somfit device is attached to the participant's forehead through a self-adhesive and disposable skin electrode patch. Wearing the device may take a little getting used to, but most people adjust fairly quickly.
Intervention code [1] 328505 0
Treatment: Devices
Intervention code [2] 328506 0
Behaviour
Comparator / control treatment
nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338127 0
Insomnia Symptom Severity
Timepoint [1] 338127 0
Immediately post treatment is the primary timepoint. This is between 0-7 days following the final CBT-Insomnia session.
ISI will be measured at baseline, post treatment and follow-up (3 months following the final CBT-Insomnia session).
Secondary outcome [1] 434610 0
Clinician experience survey
Timepoint [1] 434610 0
On completion of treatment delivery by each clinician (post treatment) 0-7 days following the final treatment session.
Secondary outcome [2] 434622 0
Client experience survey
Timepoint [2] 434622 0
Immediately post treatment (0-7 days after the final treatment session)
Secondary outcome [3] 434623 0
Fatigue symptoms
Timepoint [3] 434623 0
Immediately post treatment (0-7 days after the final treatment session)
Secondary outcome [4] 434624 0
Mood, anxiety and stress symptoms as assessed by the Depression Anxiety Stress Scale composite score.
Timepoint [4] 434624 0
Post treatment (0-7 days following the final treatment session)

Eligibility
Key inclusion criteria

Prospective participants will need to be aged 18-65, be available to attend four to eight, weekly (or fortnightly) therapy sessions, and have an Insomnia Severity Index (ISI) score of 10 or above.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are:
(i) any co-morbid pre-diagnosed, non-treated sleep disorder (e.g.,
obstructive sleep apnoea, sleep-wake cycle disorders);
(ii) the regular (3+nights per week) use of sleep
related medication;
(iii) any CBT-based treatment for insomnia in the previous 12-month period;
(iv) women who are pregnant, breastfeeding or parents with infants who need to need caregive overnight;
(v) any condition that is likely to impair the ability to participate in the treatment/study (e.g., severe mood difficulties; psychoses; neurological conditions; medical conditions requiring nursing care at night; alcohol/substance dependence; previous reaction to skin preparation, tapes and electrode gels used during PSG) ;

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study evaluating initial feasibility and effectiveness.
Treatment effects will be calculated as effect sizes and compared with existing literature on CBT-Insomnia.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
30/05/2024
Date of last participant enrolment
Anticipated
2/12/2024
Actual
Date of last data collection
Anticipated
13/05/2025
Actual
Sample size
Target
30
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316417 0
Government body
Name [1] 316417 0
An Innovation Connection Grant by the Federal Department of Industry, Science and Resources
Country [1] 316417 0
Australia
Funding source category [2] 316420 0
Commercial sector/Industry
Name [2] 316420 0
Compumedics Limited
Country [2] 316420 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Compumedics Limited
Address
Country
Australia
Secondary sponsor category [1] 318589 0
None
Name [1] 318589 0
Address [1] 318589 0
Country [1] 318589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315213 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 315213 0
Ethics committee country [1] 315213 0
Australia
Date submitted for ethics approval [1] 315213 0
Approval date [1] 315213 0
17/04/2024
Ethics approval number [1] 315213 0
2024/ET000105

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

Contacts
Principal investigator
Name 133998 0
Dr Melissa Ree
Address 133998 0
Psychological Science, The University of Western Australia, M309, 10-12 Parkway, Nedlands, Perth WA 6009 Australia
Country 133998 0
Australia
Phone 133998 0
+61 8 6488 8693
Fax 133998 0
Email 133998 0
[email protected]
Contact person for public queries
Name 133999 0
Nick Ramondo
Address 133999 0
Psychological Science, The University of Western Australia, M309, 10-12 Parkway, Nedlands, Perth WA 6009 Australia
Country 133999 0
Australia
Phone 133999 0
+61 433 786 134
Fax 133999 0
Email 133999 0
[email protected]
Contact person for scientific queries
Name 134000 0
Nick Ramondo
Address 134000 0
Psychological Science, The University of Western Australia, M309, 10-12 Parkway, Nedlands, Perth WA 6009 Australia
Country 134000 0
Australia
Phone 134000 0
+61 433 786 134
Fax 134000 0
Email 134000 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
Data may contain commercial in confidence information


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.