Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000433808
Ethics application status
Approved
Date submitted
26/02/2021
Date registered
16/04/2021
Date last updated
16/04/2021
Date data sharing statement initially provided
16/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The TIRED trial - Transdiagnostic Intervention for Remote Ex-military and first-responDers study
Scientific title
A pilot randomised controlled trial of telehealth delivered Transdiagnostic Intervention for Sleep Disorders and Circadian Rhythms (TRANS-C) among ex-military personnel and first responders
Secondary ID [1] 302327 0
None
Universal Trial Number (UTN)
U1111-1258-3419
Trial acronym
TIRED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disorders 319091 0
Posttraumatic Stress Disorder 319092 0
Condition category
Condition code
Mental Health 317045 317045 0 0
Other mental health disorders
Neurological 319274 319274 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary intervention in this trial is the Transdiagnostic Intervention for Sleep Disorders and Circadian Rhythms (TranS-C). Trans-C is a module driven approach incorporating aspects of all evidence based psychological approaches to the treatment of sleep problems. Trans-C is a module driven approach incorporating aspects of all evidence based psychological approaches to the treatment of sleep problems. The TranS-C intervention consists of four cross-cutting models, four core modules and seven optional modules delivered over 4-10 sessions depending on the complexity of the presentation (Harvey & Buysse, 2018).
Participants will be with individual participants, who will receive between 4 – 10 weekly 50-minute sessions. This intervention will be delivered by registered psychologists and the mode of delivery will be via telehealth (specifically, videoconferencing). The intervention is a manualised modular treatment and treatment sessions vary depending on presentation of sleep disorder symptoms. The location of treatment will be in the participants' own homes using video and audio enabled devices. The therapy will be delivered by psychologists within the Phoenix Australia Traumatic Stress Clinic. Treatment will be delivered according to the Transdiagnostic Sleep and Circadian Intervention clinician manual (Harvey et al. 2018). Sessions will be audio recorded for the purposes of fidelity testing. ten percent of audio recordings will be accessed by senior members of trial team for purpose of fidelity testing. A key component of treatment involves the completion of daily sleep diary entries to track/monitor sleep habits. Using an ecological-momentary-assessment framework, a digitised version of the TranS-C sleep diary is utilised in this trial to enable participants to complete daily diary entries on their personal smartphone devices.
Intervention code [1] 318617 0
Treatment: Other
Comparator / control treatment
The control group in this trial is a waitlist control group (delayed treatment).
The wait listed participants will be offered Trans-C treatment after the 12 weeks waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 325143 0
Severity of sleep symptoms--assessed using the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [1] 325143 0
posttreatment - 2 weeks after treatment completion
Primary outcome [2] 325145 0
Satisfaction with the TranS-C treatment--assessed using the Client Satisfaction Questionnaire
Timepoint [2] 325145 0
posttreatment - 2 weeks after treatment completion
Primary outcome [3] 325146 0
Satisfaction of telehealth treatment delivery--assessed using the Teleneuropsychology Patient Experience Survey
Timepoint [3] 325146 0
Posttreatment - 2 weeks after treatment completion
Secondary outcome [1] 386987 0
Posttraumatic Stress Disorder severity-assessed using the PTSD Checklist for DSM-5 (PCL-5)
Timepoint [1] 386987 0
posttreatment, follow-up (3-months posttreatment)
Secondary outcome [2] 386988 0
Symptoms of depression--assessed using the Patient Health Questionnaire-9 (PHQ9)
Timepoint [2] 386988 0
posttreatment, follow-up (3-months posttreatment)
Secondary outcome [3] 386992 0
Symptoms of Anxiety--assessed using the Generalized Anxiety Disorder 7-item scale (GAD7)
Timepoint [3] 386992 0
posttreatment, follow-up (3-months posttreatment)
Secondary outcome [4] 393985 0
Posttraumatic Stress Disorder diagnosis- assessed with PTSD module of the Mini International Neuropsychiatric Interview (MINI)
Timepoint [4] 393985 0
posttreatment, follow-up (3-months posttreatment)
Secondary outcome [5] 393986 0
Sleep disorder diagnosis - assessed using The Structured Clinical Interview for DSM-5 Sleep Disorders - Revised
Timepoint [5] 393986 0
posttreatment, follow-up (3-months posttreatment)
Secondary outcome [6] 393987 0
Alcohol use severity - assessed with Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [6] 393987 0
posttreatment, follow-up (3-months posttreatment)

Eligibility
Key inclusion criteria
1) Aged 18 years or older.
2) Are a Victorian-based veteran or first responder
3) Have access to an electronic device offering audio-visual connectivity to Zoom.
4) Meet criteria for diagnosable sleep disorder.
5) Are able to maintain a stable dose throughout the assessment and treatment period if on a pre-existing medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current serving members of the ADF.
• Participants residing outside of state of Victoria (excluding residents of towns on the Victorian border)
• Participants who meet criteria for a current diagnosis of severe Alcohol or other Substance Use disorder.
• Participants who are actively psychotic or manic, or acutely suicidal or pose another form of risk to self or other warranting alternative, immediate intervention.
• Participants who are enrolled in another service offering sleep treatment.
• Participants who report persistent, poorly controlled pain interfering with sleep.
• Participants who report serious medical condition, interfering with sleep.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a pilot RCT,
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power was estimated via an apriori power analysis using the “pwr” package in Program R. Using the “pwr.f2.test” function, the power analysis indicated that, a sample size of approximately 40 participants, produced 80% power to detect a medium to large effect size (f2 = .25), given an alpha level of 0.05. We expected dropout rate of 30% (Harvey et al., 2016), and thus aim to recruit 58 participants in total.

To assess the efficacy of the Trans-C treatment, a standard pre-treatment (Time 1), post-treatment (Time 2) assessment design is used, as is common in randomised controlled trials. Assessing symptoms at these time points allows for analysis of symptom change across time, while controlling for baseline differences in initial symptoms, between the two groups (treatment vs control[delayed treatment]).
In addition to this, a 3-month follow up assessment period (Time 3) is included in the assessment protocol to determine the extent to which treatment effects persist after treatment completion.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2020
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
58
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306750 0
Government body
Name [1] 306750 0
Department of Premier and Cabinet - Victorian Government
Country [1] 306750 0
Australia
Funding source category [2] 306754 0
Other Collaborative groups
Name [2] 306754 0
Canadian Centre of Excellence on PTSD
Country [2] 306754 0
Canada
Primary sponsor type
University
Name
Phoenix Australia - Centre for Posttraumatic Mental Health, Department of Psychiatry, University of Melbourne
Address
3/161 Barry St, Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 307310 0
None
Name [1] 307310 0
None
Address [1] 307310 0
None
Country [1] 307310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306922 0
The Departments of Defence and Veterans' Affairs Human Research Ethics Committee
Ethics committee address [1] 306922 0
Campbell Park Offices, Canberra, ACT 2610
Ethics committee country [1] 306922 0
Australia
Date submitted for ethics approval [1] 306922 0
20/05/2020
Approval date [1] 306922 0
09/09/2020
Ethics approval number [1] 306922 0
263-20

Summary
Brief summary
By the nature of their work, veterans and first-responders are vulnerable to developing difficulties with sleep (e.g. insomnia), and these problems can sometimes affect mental health and vice versa.

The aim of this clinical trial is to investigate the effectiveness of a new treatment for sleep disorders called the Transdiagnostic Sleep and Circadian Intervention (Trans-C), and its efficacy when delivered using tele-health (via videoconferencing).

In this trial, the Trans-C treatment is provided to veterans and first responders who meet the trial eligibility criteria. Eligible participants will be randomly allocated into one of two conditions: 1) an immediate treatment condition or 2) a wait-list delayed treatment condition (individuals who receive treatment after 12 weeks waiting period). Participation also involves completing a number of clinical interviews and self-report questionnaires over the duration of the trial. Additional daily assessments of sleep quality is also collected using a smartphone app, and objective sleep quality data is collected via a provided actigraph (i.e., watch) worn for the duration of treatment.

Early studies using TranS-C intervention are showing that sleep can be improved, as well as benefits gained in mental health and overall well being, and this trial is examining whether similar benefits can be seen when treatment is delivered via telehealth, and if improvements can also be seen in high risk exposed populations such as veterans and first responders.

We expect that participants who receive the TranS-C intervention, will demonstrate significant improvements in sleep, as well as other mental health symptoms (e.g., PTSD, depression, anxiety). In addition to this, we expect that participants will be satisfied with the TranS-C treatment, as well as the delivery of the treatment via tele-health.
Trial website
https://www.phoenixaustralia.org/expertise/research/current-treatment-trials/the-tired-trial/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105458 0
Prof Meaghan O'Donnell
Address 105458 0
Phoenix Australia - Centre for Posttraumatic Mental Health,
Department of Psychiatry,
University of Melbourne
3/161 Barry St, Carlton VIC 3053
Country 105458 0
Australia
Phone 105458 0
+61 3 9035 3593
Fax 105458 0
Email 105458 0
[email protected]
Contact person for public queries
Name 105459 0
Dr Dzenana Kartal
Address 105459 0
Phoenix Australia - Centre for Posttraumatic Mental Health,
Department of Psychiatry,
University of Melbourne
3/161 Barry St, Carlton VIC 3053
Country 105459 0
Australia
Phone 105459 0
+61 3 9035 9722
Fax 105459 0
Email 105459 0
[email protected]
Contact person for scientific queries
Name 105460 0
Dr Winnie Lau
Address 105460 0
Phoenix Australia - Centre for Posttraumatic Mental Health,
Department of Psychiatry,
University of Melbourne
3/161 Barry St, Carlton VIC 3053
Country 105460 0
Australia
Phone 105460 0
+61 3 9035 3593
Fax 105460 0
Email 105460 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


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.