Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000158763
Ethics application status
Approved
Date submitted
19/01/2022
Date registered
31/01/2022
Date last updated
17/01/2024
Date data sharing statement initially provided
31/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Research on Insomnia, Stress & Emotions (ARISE): The effect of Cognitive Behavioural Therapy for Insomnia (CBTI) on rapid eye movement (REM) sleep, fear extinction, and safety signal recall in insomnia patients.
Scientific title
Australian Research on Insomnia, Stress & Emotions (ARISE): Examining the role of rapid eye movement (REM) sleep in trauma recovery mechanisms in Insomnia patients.
Secondary ID [1] 306138 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ARISE (Australian Research on Insomnia, Stress & Emotions)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 324832 0
Condition category
Condition code
Mental Health 322270 322270 0 0
Other mental health disorders
Neurological 322271 322271 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either an active treatment or waitlist control condition.

Participants randomised to the active treatment condition will immediately receive 7 weekly treatment sessions of Cognitive Behavioural Therapy for Insomnia (CBTI), following their pre-treatment testing phase. This will be delivered via telehealth (i.e., via Zoom) with a trained clinician. Each treatment session will last approx. 1 hour and will take the format of individual, one-on-one sessions (i.e., one clinician per client).

Throughout the 7-week intervention period, participants will be asked to wear an actigraph/fitbit 24-hours per day (except when engaged in activities that may damage the device). Participants will also be asked to complete a daily sleep diary throughout the treatment program and to practice 1-3 strategies learnt in session in between therapy sessions. Ideally, these strategies are used daily.

The Intervention:
CBTI is the current gold-standard treatment for insomnia, and a multicomponent intervention. Clinicians will work with clients to help them make changes to their sleep-wake patterns, to improve sleep. This includes setting regular sleep and wake times, getting out of bed when one is unable to sleep, sleep restriction and stimulus control. CBTi also addresses common misconceptions about sleep and unhelpful thought patterns, which may be perpetuating sleep problems. Finally, CBTi includes education about improving the sleep environment and relaxation techniques.

Clinicians:
Sleep clinicians will be registered provisional psychologists, trained by Chief Investigator, Prof Drummond, who has clinical expertise in treating behavioural sleep disorders such as Insomnia Disorder. Clinicians will be trained using methods based on those recommended by leading experts in the field.

Fidelity:
All clinicians will be regularly evaluated to ensure they are delivery the intervention properly. All treatment sessions will be recorded over Zoom. Every session from the first two cases of each treatment and 10% of all subsequent sessions will be evaluated by a registered psychologist trained in CBT-I for treatment fidelity (based on standardised check lists of session content). All recordings will be securely stored, kept highly confidential, and only accessed by the research team for the purpose of fidelity checks.

Adherence:
Adherence to treatment will be monitored throughout the intervention via the daily sleep diary, and a weekly adherence questionnaire administered by the clinician. This questionnaire was designed by the investigators to gauge the individual’s adherence to 7 specific CBT-I activities (e.g., completing sleep diaries, stimulus control etc.) each week.
Intervention code [1] 322543 0
Behaviour
Intervention code [2] 322544 0
Treatment: Other
Comparator / control treatment
Participants randomised to the waitlist control condition will be informed that they are placed on a waitlist for treatment. Instead of commencing treatment straight away, they will simply be asked to continue wearing the actigraph/fitbit and completing daily sleep diaries for the duration of the 7 weeks. Participants in this group will receive their 7 weeks of CBTI once completing the study.
Control group
Active

Outcomes
Primary outcome [1] 330034 0
Primary Outcome 1: Rapid Eye Movement (REM) sleep fragmentation.

The following REM variables will be measured using a portable polysomnography (PSG) device during both pre- and post-treatment testing phases:

1. REM % = REM sleep duration / total sleep duration.
2. REM Latency = Duration of non-REM sleep before the 1st REM onset.
3. REM Efficiency = Number of REM minutes / total duration of all REM periods.

These REM measures will also be used to calculate a REM consolidation index as a measure of fragmentation (lower consolidation = greater fragmentation). Lower REM%, shorter REM latency, and lower REM efficiency will serve as indices of reduced REM consolidation and thus, greater REM fragmentation. The calculation of this latent variable will be based on the model developed in our seminal studies showing REM fragmentation is negatively associated with recall of both safety and extinction.
Timepoint [1] 330034 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Primary outcome [2] 330035 0
Primary Outcome 2: Fear inhibition
This will be assessed via participants' extinction and safety signal recall performance in the fear potentiated startle task (greater extinction and safety retention = greater fear inhibition).
Timepoint [2] 330035 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [1] 404694 0
Secondary outcome 1: Insomnia symptom severity

This is operationalised by scores on the Insomnia Severity Index (ISI).
Timepoint [1] 404694 0
Time point 1: Pre-treatment/baseline
Time point 2: During treatment in weeks 1-7
Time point 3: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [2] 404695 0
Secondary outcome 2: Psychiatric symptoms - Anxiety

This is operationalised by scores on the PROMIS Anxiety 8a scale.
Timepoint [2] 404695 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [3] 404714 0
Secondary outcome 3: Psychiatric symptoms - Depression

This is operationalised by scores on the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [3] 404714 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [4] 404715 0
Secondary outcome 4: Quality of life/wellbeing

This is operationalised by scores on the PROMIS satisfaction scale and the Warwick Edinburgh Mental Wellbeing Scale (WEMWS).
Timepoint [4] 404715 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [5] 404716 0
Secondary outcome 5: Cognition

This is operationalised by scores on the British Columbia Cognitive Complaints Inventory (BC-CCI).
Timepoint [5] 404716 0
Time point 1: Pre-treatment/baseline
Time point 2: During treatment in week 4
Time point 3: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [6] 404717 0
Secondary outcome 6: Pre-sleep arousal

This is operationalised by scores on the Presleep Arousal Scale (PSAS).
Timepoint [6] 404717 0
Time point 1: Pre-treatment/baseline
Time point 2: During treatment in week 4
Time point 3: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [7] 404719 0
Secondary outcome 7: Fatigue

This is operationalised by scores on the Flinders Fatigue Scale (FFS).
Timepoint [7] 404719 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [8] 405620 0
Secondary outcome 8: Sleep-related impairment

This is operationalised by scores on the PROMIS sleep related impairment scale
Timepoint [8] 405620 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [9] 405621 0
Secondary outcome 9: Sleepiness

This is operationalised by scores on the Epworth Sleepiness Scale (ESS).
- Ford Insomnia Response to Stress Test (FIRST)
Timepoint [9] 405621 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [10] 405622 0
Secondary outcome 10: Stress-related sleep reactivity

This is operationalised by scores on the Ford Insomnia Response to Stress Test (FIRST).
Timepoint [10] 405622 0
Time point 1: Pre-treatment/baseline
Time point 2: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [11] 405623 0
Secondary outcome 11: Dysfunctional beliefs about sleep

This is operationalised by scores on the Dysfunctional Beliefs About Sleep (DBAS) scale.
Timepoint [11] 405623 0
Time point 1: Pre-treatment/baseline
Time point 2: During treatment in week 6
Times point 3: Post-treatment (1-2 weeks following final treatment session)
Secondary outcome [12] 405624 0
Secondary outcome 11: State anxiety

This is operationalised by scores on the state version of the State Trait Anxiety Inventory (STAI).
Timepoint [12] 405624 0
Time point 1: Pre-treatment/baseline (at bedtime during pre-treatment in-lab sleep study)
Time point 2: Pre-treatment/baseline (before fear potentiated startle task during pre-treatment testing)
Time point 3: 1-2 weeks post-treatment (at bedtime during post-treatment in-lab sleep study)
Time point 4: 1-2 weeks post-treatment (before fear potentiated startle task during post-treatment testing)

Eligibility
Key inclusion criteria
a) Insomnia Disorder
b) 18-70 years of age
c) Fluent in English
d) Full vaccination status (COVID-19)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Unmanaged sleep disorders other than insomnia and extreme chronotypes
b) History of night or early morning shift work in the past 3 months or transmeridian travel (greater or equal to 2 time zones) in the past 2 months
c) Current behavioural treatment for insomnia (or within past month)
d) Major mental health condition(s) known to affect REM sleep or fear inhibition
e) Major physical health condition(s)
f) Current Substance Use Disorder (including Alcohol Abuse), frequent cannabis use or other recreational drug use
g) Current use or recent discontinuation of medications known to affect REM sleep or fear inhibition. These include, SSRIs/SNRIs, tricyclic antidepressants, opiates, orexin antagonists, benzodiazepines, hypnotics, corticosteroids and ADHD medication (methylphenidate, amphetamine etc). Participants may be eligible to participate if the drug has been safely discontinued for a minimum duration equivalent to 5 half-lives of the drug.
h) Failure to exhibit a consistent startle response on day of screening (i.e., over 75% discernible response to six 108-dB 20ms startle pulses), as a normal startle response is necessary to measure fear inhibition via the fear potentiated startle task we will use.
i) Failure to respond to a 35 dB pulse at 500, 1000 and 3000 Hz in both ears when tested via an audiometer.
j) Age above 70 years, as this group has been shown to exhibit diminished startle responses and fear conditioning rates. Normal startle responding and fear conditioning rates are required for the paradigm used to test one of the main outcomes of interest (i.e., fear and safety recall in the fear-potentiated startle task).
k) Living with a children under 1 year of age, as they impact sleep.
l) Currently pregnant or breastfeeding, or actively trying to conceive. Major changes in sex hormones during these stages are likely to affect fear conditioning and extinction measures.
m) Any current treatments involving sex hormones (e.g., gender-affirming hormone treatments, fertility treatments), with the exception of birth control and hormone replacement therapies (e.g., estrogen replacement therapy in peri/postmenopausal women) if the participant has been on a stable dose for at least 3 months. If the participant has just come off hormone replacement therapy, a period of 3 months for hormones to re-stabilise is required before study participation.
n) Hot flashes which are frequent or cause significant interference with sleep
o) Any other factor that the researcher determines will affect study outcome.

In-treatment exclusions:
a) Hospitalisation
b) Taking >10 weeks to complete the 7-week treatment program.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
7/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310481 0
Government body
Name [1] 310481 0
National Health and Medical Research Council
Country [1] 310481 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,
Clayton Campus, Wellington Road,
Clayton, Victoria 3800
Country
Australia
Secondary sponsor category [1] 311642 0
None
Name [1] 311642 0
Address [1] 311642 0
Country [1] 311642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310111 0
Monash University Human Research Ethics Committees (MUHREC)
Ethics committee address [1] 310111 0
Ethics committee country [1] 310111 0
Australia
Date submitted for ethics approval [1] 310111 0
18/11/2021
Approval date [1] 310111 0
01/12/2021
Ethics approval number [1] 310111 0

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

Contacts
Principal investigator
Name 116514 0
Prof Sean P. A. Drummond
Address 116514 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk, Room 542
Clayton, VIC 3800
Country 116514 0
Australia
Phone 116514 0
+61 3 9905 3956
Fax 116514 0
Email 116514 0
[email protected]
Contact person for public queries
Name 116515 0
Alix Mellor
Address 116515 0
Sleep and Circadian Medicine Laboratory
Be Active Sleep Eat Facility
264 Ferntree Gully Road
Monash University
Notting Hill VIC 3168
Australia
Country 116515 0
Australia
Phone 116515 0
+61 3 99055912
Fax 116515 0
Email 116515 0
[email protected]
Contact person for scientific queries
Name 116516 0
Sean P. A. Drummond
Address 116516 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk, Room 542
Clayton, VIC 3800
Country 116516 0
Australia
Phone 116516 0
+61 3 9905 3956
Fax 116516 0
Email 116516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic information, questionnaire data collected during baseline symptoms and post-treatment assessments, and weekly data collected during treatment. All data will be de-identified.
When will data be available (start and end dates)?
Data underlying each manuscript will be made available following publication of that manuscript. All other data will be made available 36 months after the end of the trial. No end date is yet determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
No limits
How or where can data be obtained?
Access subject to approvals by Principal Investigator. The data will be placed on a Monash University sponsored data repository.

Principal Investigator Prof Sean Drummond can contacted via email ([email protected]) or phone (+61 3 9905 3956).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14597Ethical approval    383364-(Uploaded-06-01-2022-12-28-16)-Study-related document.pdf



Results publications and other study-related documents

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