Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001086752
Ethics application status
Approved
Date submitted
13/07/2022
Date registered
5/08/2022
Date last updated
27/08/2024
Date data sharing statement initially provided
5/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Direct to Psychology Insomnia and Stepped Care Models in a Sleep Disorders Service
Scientific title
Direct to Psychology and Stepped Care Innovations in Multidisciplinary Sleep Management in a Public Hospital Setting
Secondary ID [1] 307556 0
none
Universal Trial Number (UTN)
U1111-1280-3149
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia
 326996 0
Obstructive Sleep Apnoea 326997 0
Parasomnias 326998 0
Central Disorders of Hypersomnolence 326999 0
Nightmare Disorder 327000 0
Sleep Phase Disorders 327001 0
Condition category
Condition code
Mental Health 324183 324183 0 0
Other mental health disorders
Public Health 324184 324184 0 0
Health service research
Respiratory 324185 324185 0 0
Sleep apnoea
Neurological 324230 324230 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overarching aim of this project is to develop, refine, implement and report on two concurrent changes in the service model in the Sleep Disorders Centre at The Prince Charles Hospital (TPCH) to incorporate a “Direct to Psychology Insomnia” referral pathway, and a “Stepped Care” model of care within the TPCH Sleep Psychology Service, flexibly delivered across the continuum of care. The project will measure the impact of the service change in our target population. The service change will be compared to the current service models for key outcomes.

An implementation science approach will be used throughout this project. We propose to trial a “Direct to Psychology” Insomnia model, whereby new referrals to our Sleep Disorders service will be triaged initially by a Sleep Physician (as is currently the case) and directed to either Standard of Care and waitlisted for a Sleep Physician initial consultation, or to the NEW “Direct to Psychology” pathway. All patients entering the service will undergo this triage process. A key goal of the project is to refine our triage criteria for determining who should assigned to the Physician Initial consultation pathway (Standard Care) or to the Direct to Psychology pathway. However, we will be modelling this triage process based on criteria developed by Krebs & Ellender (2021), who published data from the Princess Alexandra Hospital Sleep Disorders Service (Queensland, Australia) evaluating their referrals between 2016-2019. In a retrospective cohort study capturing new cases, patients were categorised as either “suitable for direct to psychology” or “required medical review”.
The “direct to psychology” patients were defined as
i. referred for insomnia; or
ii. Insomnia Severity Index score (ISI) =15/28; or
iii. diagnosed with insomnia per ICSD-3 by treating specialist; or
iv. patients referred for sleep psychology.
Exclusion criteria were:
i. significant sleep disordered breathing (Epworth sleepiness scale >16, referral or identified significant sleep disordered breathing,
ii. highly co-morbid patients (neuromuscular weakness, COPD) and
iii. diagnosis of hypersomnia.
These patients were categorised as “requiring medical review”.

Krebs, L., & Ellender, C. (2021). Improving Patient Streaming for Chronic Insomnia: Single Centre Retrospective Cohort Study. Sleep Advances, 2 (S1), A43.

All patients referred to the Sleep Psychology service, either via the traditional Physician first route (Standard Care) or through the Direct to Psychology route, will undergo a specialist clinical assessment with an advanced clinical psychologist with training in the assessment and management of insomnia, as well as the skills to identify and refer patients requiring medical intervention back to the Sleep Physician. This assessment is 60-90 minutes in duration. This assessment will include a thorough sleep history, sleep diary, detailed medical, substance use, and psychiatric history (including suicide/self-harm risk assessments, particularly for patients presenting with depression). The sleep history will cover the history of and current details regarding the sleep complaints, pre-sleep conditions, sleep-wake patterns, other sleep-related symptoms, lifestyle factors, and daytime consequences. The history helps to establish the type and evolution of sleep difficulties, perpetuating factors, and identification of comorbid medical, substance, and/or psychiatric conditions. If another sleep disorder is suspected (e.g., Obstructive Sleep Apnoea (OSA); Periodic Limb Movements of sleep (PLMs), patients will be referred back to the Sleep Physician for concurrent assessment and management.

After the clinical assessment with the Clinical Psychologist, all patients (regardless of pathway into the Sleep Psychology service) will be assigned to a new Stepped Care Model pathway and. We propose that there will be 4 levels of the Stepped Care Model associated with increasing complexity, however an aim of the project is to refine these "Steps" as part of our project. At the time of clinical assessment, participants will be assigned by the Clinical Psychologist to the level most relevant to their needs upon entry to the pathway. We expect that most patients will be assessed as suitable for entry to first-line manualised and online treatment programs, increasing to progressively more time, cost and expertise intensive levels ‘upstream’ where there is an incomplete therapeutic response to a first-line intervention. Determinations of where patients should enter into the Stepped Care model, is determined by the specialist clinical psychologist at initial clinical evaluation, and reassessed throughout the treatment journey.
The proposed Levels of the Stepped Care model are based on Espie's (2009) Cognitive Behaviour Therapy for Insomnia (CBTi) Stepped Care model utilised in the National Health Service (NHS).

Espie, C. (2009), "Stepped care": a health technology solution for delivering cognitive behavioral therapy as a first line insomnia treatment. Sleep 32 (12): 1549-1558.

A description of our proposed Levels/Steps in our Stepped Care Model are below:

- Level 1: Online insomnia program - "Managing Insomnia" by "This Way Up".
https://thiswayup.org.au/programs/insomnia-program/

This program is an evidence-based insomnia intervention, free by Clinician prescription, developed by "This Way Up" - a digital therapies service through St Vincent's Hospital, Sydney, Australia. This therapy consists of 4 sessions, which the client guides themselves through at their own pace. Each session takes about one hour to complete and is designed to be completed at one session per week. However, participants have up to 90 days to complete the program once they start. The sessions are presented in a comic-book like format, and patients are prompted to complete questionnaires and sleep diaries throughout the sessions to facilitate engagement with the material. The referring Clinical Psychologist is able to track the progress of the patient, including their commencement of the program and completion of each session, as well as their outcome measures collected at each session (insomnia severity index and K-10 score). If the patient has not engaged with the digital therapy within 4 weeks of being prescribed the intervention, reasons for this will be discussed and options for discharge, on-referral and/or entry to another intervention level will be provided.

Level 2: Group program and sleep manual facilitated by experienced Clinical Psychologist;
Our insomnia group intervention and sleep manual was developed by our Sleep Psychology team from evidence-based insomnia treatment developed at Flinders University, Adelaide, Australia. The intervention is 4 sessions and covers the key components of insomnia treatment - sleep restriction therapy, stimulus control, cognitive therapy, relaxation training and sleep hygiene. Each session is 90 minutes, and there are a maximum of 6 participants in each group session. On engagement with this treatment Level, the Clinical Psychologist, with Psychology Intern co-facilitating, will monitor participation and clinical outcomes during the group program (4 sessions of group CBTi with up to 6 participants). Depending on patient engagement and participation with the program, as well as clinical outcomes on key assessment measures; discharge, on-referral and/or entry to another intervention level will be provided.

Sweetman, A., McEvoy, D., Smith, S., Catheside, P., Antic, N., Chai-Coetzer, C., Douglas, J., O’Grady, A., Dunn, N., Robinson, J., Paul, D., Williamson, P., & Lack, L. (2020). The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial. Sleep, 43:zsaa002.

Level 3: 1:1 and sleep manual with Sleep Psychology Intern.
Patients assigned to this level will undergo treatment 1:1 with the Psychology Intern under supervision from the Clinical Psychologist. We will monitor participation and clinical outcomes during the 1:1 intervention program (minimum 4 sessions of CBTi as described above for Level 2) with additional evidence-based strategies depending on sleep or mental health comorbidities such as CBT for depression/anxiety, dream rescripting for nightmares, Motivational Interviewing for Continuous Positive Airway Pressure (CPAP) adherence for those with comorbid OSA). Each of these additional sessions will be 60 minutes in duration, and will be delivered at a weekly to fortnightly interval between sessions. The number of sessions will depend on how many sessions the patient requires to achieve adequate symptom relief based on ongoing assessment and monitoring. Depending on patient engagement and participation with the intervention, as well as clinical outcomes on key assessment measures; discharge, on-referral and/or entry to another intervention level will be provided.

Level 4: 1:1 and sleep manual with Advanced/Senior Clinical Psychologist.
On engagement with this treatment Level, the Clinical Psychologist will monitor participation and clinical outcomes during the 1:1 intervention program (CBTi program described above), and provide additional evidence -based strategies depending on sleep or mental health comorbidities (as described in Level 3 above).

For Levels 2 to 4 - sessions will be delivered flexibly either face-to-face or telehealth
Intervention code [1] 324017 0
Treatment: Other
Intervention code [2] 324018 0
Diagnosis / Prognosis
Intervention code [3] 324019 0
Behaviour
Comparator / control treatment
Baseline data from our existing (standard care) model will be collected prior to implementation of our service changes as a comparator to our interventions. The baseline data will be collected from 1 January 2021 to 30 June 2023
Control group
Historical

Outcomes
Primary outcome [1] 331998 0
primary service evaluation end-point:

Time from referral to treatment commencement and discharge. This data will be collected via audit of the patient medical record, which collects data on date of referral, date of first patient contact (assessment session) and date of final session (discharge)
Timepoint [1] 331998 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Primary outcome [2] 331999 0
primary patient outcomes end-point:

Change score on key clinical outcome measure Insomnia Severity Index (ISI) from pre to post clinical intervention provided at the relevant 'step/steps' of the Stepped Care Model.
Timepoint [2] 331999 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Primary outcome [3] 332052 0
primary patient outcomes end-point:

Change score on key clinical outcome measure Depression, Anxiety and Stress Scale (DASS-21) from pre to post clinical intervention provided at the relevant 'step/steps' of the Stepped Care Model.
Timepoint [3] 332052 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Secondary outcome [1] 411860 0
Service Evaluation end-point:
New Patient activity for sleep psychology service as measured by clinical audit of number of referrals to the service over the project time frame
Timepoint [1] 411860 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Secondary outcome [2] 411861 0
Patient Outcomes end-point:
% patients treated adequately at each step of the Stepped Care Model as measured by comparing the number of patients discharged from the service by the treating clinician as 'treatment complete' (this is a composite measure of subjective clinician judgement as well as outcome measures indicating reliable clinical change from pre- to post- intervention on the DASS21, K10 and ISI), to the number of patients who were discharged without 'treatment complete' (eg, withdrew prematurely, did not achieve symptom resolution).
Timepoint [2] 411861 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.
Secondary outcome [3] 411987 0
(primary) patient outcomes end-point:

Change score on Health Related Quality of Life Measure EuroQol (EQ-5D-5L) from pre to post clinical intervention provided at the relevant 'step/steps' of the Stepped Care Model.
Timepoint [3] 411987 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Secondary outcome [4] 411989 0
Occasions of Service within Sleep Psychology service as measured by clinical audit of number of appointments attended by patients with a clinician from assessment to discharge

Timepoint [4] 411989 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Secondary outcome [5] 411990 0
Number of patients assigned to each level of the Stepped Care model as measured by a clinical audit of assigned treatment pathway.
Timepoint [5] 411990 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.
Secondary outcome [6] 411991 0
New patient activity for patients seen by Sleep Physicians or Clinical Nurse Consultant (CNC) (if this is the first point of contact) as measured by clinical audit of number of referrals to the service over the project time frame
Timepoint [6] 411991 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Secondary outcome [7] 411992 0
Average wait time data to access first appointment with Sleep Physicians or CNC (if this is the first point of contact) from date of referral as measured by clinical audit of number of referrals to the service over the project time frame
Timepoint [7] 411992 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Secondary outcome [8] 411993 0
Engagement with the online therapy (if assigned to this intervention) as measured by a composite (via regression analysis) of two key outcome variables :
time to start the online program from date of prescription of the online therapy to date of signing up to the treatment
and number of sessions completed
These data will be collected by assessing the website analytics for the online program
Timepoint [8] 411993 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.
Secondary outcome [9] 412000 0
(primary) patient outcomes end-point:

Change score on key clinical outcome measure Kessler-10 (K-10) from pre to post clinical intervention provided at the relevant 'step/steps' of the Stepped Care Model.
Timepoint [9] 412000 0
comparing between the period of 1 January 2021-30 June 2023 as a pre-measure; to those participating in the (NEW) service initiatives planned to commence July 2023 until the end of the project.
Secondary outcome [10] 412007 0
Sleep Disorders Centre staff refinement and feedback on the proposed Direct to Psychology and Stepped Care Models, as by measured Clinician feedback during Consensus groups utilising the nominal group approach.
Workshops will be facilitated by an experienced Clinical Psychologist clinician (SW). The outcomes of this process will determine the criteria for the Direct to Psychology and Stepped Care Models.
Timepoint [10] 412007 0
Group sessions to be held between 1 August 2022 to 30 June 2023 prior to implementation of the service changes.
Secondary outcome [11] 412008 0
Feedback from GPs on their acceptability of digital therapies for treatment of their patients, as measured by composite data obtained from a specifically designed service evaluation questionnaire asking about their experience with prescribing online therapies and their likelihood of recommending the 'Managing Insomnia' online therapy to their colleagues
Timepoint [11] 412008 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.
Secondary outcome [12] 412009 0
Feedback from Sleep Disorders Centre staff on their acceptability of digital therapies for treatment of their patients, as measured by composite data obtained from a specifically designed service evaluation questionnaire asking about their experience with prescribing online therapies and their likelihood of recommending the 'Managing Insomnia' online therapy to their colleagues
Timepoint [12] 412009 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.
Secondary outcome [13] 412010 0
Feedback from patients on their acceptability of the digital therapy for treating their sleep problem, as measured by composite data obtained from a specifically designed service evaluation questionnaire asking about their experience with the 'Managing Insomnia' online therapy, and whether it resolved their sleep problem
Timepoint [13] 412010 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.
Secondary outcome [14] 412537 0
Motivation to access online insomnia treatment as measured by a 5 point Likert scale from Extremely motivated to Not at all motivated
Timepoint [14] 412537 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.
Secondary outcome [15] 412538 0
Perceived change in understanding of insomnia management as measured by a 5 point Likert scale from A tremendous amount to Not at all
Timepoint [15] 412538 0
period of July 2023 onwards from the time of implementation of the (NEW) service initiatives until the end of the project.

Eligibility
Key inclusion criteria
Patients: All NEW referrals to the Sleep Disorders Service at the Prince Charles Hospital who then are referred to Sleep Psychology at some point in their patient journey from 1 January 2021 will be eligible for inclusion

GPs: All GPs linked to patients included in the project, who respond to our surveys

Staff: Sleep Disorders Centre clinicians/team members, who agree to participate in our surveys and consensus groups
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients: New referrals prior to 1 January 2021

GPs: GPs linked to patients referred prior to 1 January 2021

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Single site, multiphase, retrospective (pre-service change 1 January 2021 to 30 June 2023) and prospective (from 1 July 2023), mixed methods pre-post evaluation (post-service change 1 July 2023 to (est.) 31 December 2025) to of a Direct to Psychology and Stepped Care Sleep Psychology Service change aligning to Standards for intervention Reporting Implementation Studies (StaRI) (Pinnock et al. 2017). The StaRI framework will be used to guide the development, implementation and reporting of this service change. With Re-AIM being the implementation framework. Sample Size: During 2021 there were 118 new referrals to sleep psychology. It is anticipated that numbers will be similar for the evaluation period. Based on the PAH study (Krebs et al., 2021) we expect about 57% will be suitable for the Direct to Psychology pathway. Allowing for some incomplete data, we expect to have data for about 110 participants from each time period; Of these we expect 63 to follow the direct path post-intervention and 63 to satisfy eligibility criteria for the pathway and 47 from each period to access sleep psychology services after following the traditional pathway. Differences in wait time will be compared between these four groups. In a one-way ANOVA study, a sample of 220 subjects, divided among 4 groups (with numbers as above), achieves 80% power with a significance level of 0.05 to detect a moderate-large effect size (Cohen’s f) of 0.25.

For differences in patient outcome measures pre- and post- intervention when comparing pre- and post- service change, the mean between-group difference and 95% confidence interval (CI) will be calculated. As this aspect of the evaluation is a non-inferiority trial (that is, we expect clinical outcomes to not be reduced due to the service change), the criteria adopted to determine non-inferiority will be if the upper bound 95%CI on each clinical outcome measure was less than the minimal clinical important difference (MCID).

Quantitative data measuring pre- and post- service change outcomes on key indices of patient patient service satisfaction, service characteristics (eg occasions of service); as well as GP and SDC clinician service satisfaction and engagement with digital therapies will be evaluated via univariate statistical tests where indicated such as independent samples t-test (or non-parametric equivalent), and categorical comparisons will be evaluated using Pearson’s chi-square. The distribution of outcome measures will be assessed and appropriate transformations will be applied for use in modelling. Differences between group means will be tested using generalised linear regression modelling.

To assess wait times, participants will be categorised into 4 groups based on the time-period (pre/post implementation) and whether they (would have) met eligibility criteria for the pathway. Differences between groups will be assessed using linear regression modelling. The effects of other variables of interest and potential confounders (patient characteristics, diagnosis,) will be tested in multivariable models.

Quantitative data collected via the Consensus Group and in open question feedback measures will be evaluated utilising Thematic Analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2022
Actual
31/08/2022
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
220
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22801 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 38087 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 311831 0
Hospital
Name [1] 311831 0
The Prince Charles Hospital
Country [1] 311831 0
Australia
Funding source category [2] 317265 0
Government body
Name [2] 317265 0
Queensland Health
Country [2] 317265 0
Australia
Primary sponsor type
Individual
Name
Dr Sara Winter
Address
Department of Psychology
Prince Charles Hospital
Rode Rd,
CHERMSIDE QLD 4032
Country
Australia
Secondary sponsor category [1] 313304 0
Individual
Name [1] 313304 0
Dr Tricia Rolls
Address [1] 313304 0
Department of Psychology
Prince Charles Hospital
Rode Rd,
CHERMSIDE QLD 4032
Country [1] 313304 0
Australia
Secondary sponsor category [2] 313305 0
Individual
Name [2] 313305 0
Dr Deanne Curtin
Address [2] 313305 0
Sleep Disorders Centre
Prince Charles Hospital
Rode Rd,
CHERMSIDE QLD 4032
Country [2] 313305 0
Australia
Secondary sponsor category [3] 313306 0
Individual
Name [3] 313306 0
Dr Irene Szollosi
Address [3] 313306 0
Sleep Disorders Centre
Prince Charles Hospital
Rode Rd,
CHERMSIDE QLD 4032
Country [3] 313306 0
Australia
Secondary sponsor category [4] 313307 0
Individual
Name [4] 313307 0
Dr Jessica Haratsis
Address [4] 313307 0
Department of Psychology
Prince Charles Hospital
Rode Rd,
CHERMSIDE QLD 4032
Country [4] 313307 0
Australia
Secondary sponsor category [5] 313463 0
Individual
Name [5] 313463 0
Dr Tamlyn Rautenberg
Address [5] 313463 0
Campbell Place Building 2 - Lobby 4 Level 2
The University of Queensland
St Lucia
Queensland, 4067
Country [5] 313463 0
Australia
Other collaborator category [1] 283147 0
Individual
Name [1] 283147 0
Dr Daniel Sullivan
Address [1] 283147 0
Country [1] 283147 0
Australia
Other collaborator category [2] 283148 0
Individual
Name [2] 283148 0
Ms Sara Crocker
Address [2] 283148 0
Country [2] 283148 0
Australia
Other collaborator category [3] 283149 0
Individual
Name [3] 283149 0
Ms Elena Bild
Address [3] 283149 0
Country [3] 283149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311273 0
Darling Downs HREC
Ethics committee address [1] 311273 0
Ethics committee country [1] 311273 0
Australia
Date submitted for ethics approval [1] 311273 0
27/07/2022
Approval date [1] 311273 0
24/08/2022
Ethics approval number [1] 311273 0
HREC/2022/QTDD/88350

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

Contacts
Principal investigator
Name 120530 0
Dr Sara Winter
Address 120530 0
Department of Psychology
The Prince Charles Hospital
Rode Rd
CHERMSIDE QLD 4032
Country 120530 0
Australia
Phone 120530 0
+61 7 31396387
Fax 120530 0
Email 120530 0
[email protected]
Contact person for public queries
Name 120531 0
Sara Winter
Address 120531 0
Department of Psychology
The Prince Charles Hospital
Rode Rd
CHERMSIDE QLD 4032
Country 120531 0
Australia
Phone 120531 0
+61 7 31396387
Fax 120531 0
Email 120531 0
[email protected]
Contact person for scientific queries
Name 120532 0
Sara Winter
Address 120532 0
Department of Psychology
The Prince Charles Hospital
Rode Rd
CHERMSIDE QLD 4032
Country 120532 0
Australia
Phone 120532 0
+61 7 31396387
Fax 120532 0
Email 120532 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
Only aggregate data will be available for publication/dissemination to the public


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.