Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000372684
Ethics application status
Approved
Date submitted
27/03/2023
Date registered
13/04/2023
Date last updated
21/05/2024
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of an adjunctive intervention for Debilitating Symptom Complexes Attributed to Ticks (DSCATT) – an Acceptance and Commitment Therapy (ACT) based transdiagnostic approach
Scientific title
Feasibility of an Acceptance and Commitment Therapy (ACT) based adjunctive intervention for Debilitating Symptom Complexes Attributed to Ticks (DSCATT) – a randomised, waitlist-controlled pilot and feasibility trial
Secondary ID [1] 309235 0
None
Universal Trial Number (UTN)
Trial acronym
FIND trial
Linked study record
Follow-up study to ACTRN12621001032842

Health condition
Health condition(s) or problem(s) studied:
Debilitating Symptom Complexes Attributed to Ticks (DSCATT) 329391 0
Condition category
Condition code
Other 326337 326337 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a 16-session treatment program based on principles of Acceptance and Commitment Therapy (ACT), guided by a purpose designed therapist manual and corresponding participant workbook. Manualized modules include (I) education on concepts of health and illness and the neurobiology of symptom experience in DSCATT, (ii) core principles of ACT, (iii) evaluating daily routines (iv) increasing levels of activity (v) identifying and connecting with values, (vi) setting goals (vii) addressing avoidant cognitions and behaviours through mindfulness skills (viii) strategies for managing the uncertainty of illness. Additional modules on self-compassion, improving sleep, addressing difficulties with thinking and memory, and navigating social relationships will be administered according to participant need. Trial clinicians will have the capacity to flexibly adapt individual sessions to suit the presenting needs of participants. Behaviour and/or cognitions that are the therapeutic focus will be patient-led, according to what the participants feels is the most pressing issue/problem for them. This will guide the order of delivery of modules between session 6 and 10, contingent on where the participant is currently at in their recovery. Participants will be provided with homework tasks each week via email, to be completed between sessions, in order to practice introduced skills and concepts. Participants will be asked to set aside up to 1 hour each week to complete recommended activities. Homework worksheets provided to the participants are included in the Participant workbook. A reminder email or SMS, based on the participants' communication preferences, will be delivered during the week to follow up on homework tasks. A review of homework tasks will be performed each session, including whether the participant completed the set homework and discussion of progress and any challenges experienced.

The intervention will be delivered via Telehealth, or face to face if participants are able to attend on site at the Austin Hospital in Heidelberg VIC. Therapy sessions will be provided to participants individually (one-to-one) by registered psychologists who have received training in this model of therapy (facilitated by Chief Investigators Prof Trudie Chalder and Prof Sarah Wilson). The first session will be 90 minutes, whereas follow-up sessions 60 minutes. Sessions will be offered once per week, however, participants will have 20-weeks to complete all 16-sessions to accommodate for cancellations/rescheduled appointments.

Treatment adherence (visits attended) will be recorded by the trial therapists. All sessions will be audio-recorded, and a proportion (10%) will be independently assessed for treatment fidelity (i.e., therapists’ adherence to the treatment manual) using a standardised schedule by Prof Chalder.
Intervention code [1] 325677 0
Treatment: Other
Comparator / control treatment
The study will be waitlist controlled. Participants will be randomly assigned to either the 16 session ACT-based intervention, or waitlisted (control participants) for 32-weeks. Control participants will continue their usual treatments/care, and then offered access to the intervention after they complete their Week-32 study questionnaires. Usual treatments/care may vary between participants depending on their presenting symptoms and illness severity. Treatments may include, but are not limited to, prescription medications, vitamins/supplements, herbal medicines, complementary and alternative therapies, allied health services.
Control group
Active

Outcomes
Primary outcome [1] 334189 0
Acceptability of the intervention informed by the number of participants who do NOT withdraw prematurely from the ACT-based intervention (retention rate). Participant completion and withdrawal rates will collated by the project coordinator and trial therapists and entered into the study 'recruitment and tracking' database.
Timepoint [1] 334189 0
These figures will be collated by the project coordinator and trial therapists as participants complete and withdraw from the intervention, up until conclusion of the trial.
Primary outcome [2] 334271 0
Participants satisfaction with treatment measured quantitatively by a participant self-report treatment satisfaction questionnaire developed by the researchers; and qualitatively by a one-on-one post treatment feedback interview
Timepoint [2] 334271 0
20-weeks post randomisation
Primary outcome [3] 334272 0
Demand for the trial informed quantitatively by the number of inquiries received about the trial via website/telephone/email whilst recruitment is open (inquiry rate), as well as the number of people who consent to participate (participation rate) whilst recruitment for the trial is open. The project coordinator will enter these figures in the study 'inquiry & pre-screening' log. In addition, field notes will be kept by the project coordinator detailing reasons why people decide NOT to participate (qualitative data).
Timepoint [3] 334272 0
These data will be recorded by the project coordinator whilst recruitment for the trial is open, and assessed at the conclusion of the study.
Secondary outcome [1] 419780 0
Quality of life measured by the Assessment of Quality of Life 8-dimension scale (AQoL 8D)
Timepoint [1] 419780 0
Baseline (prior to randomisation) and at all follow-up time points (10-weeks, 20-weeks & 32-weeks after randomisation)
Secondary outcome [2] 419781 0
Functioning, measured by the Work and Social Adjustment Scale (WSAS)
Timepoint [2] 419781 0
Baseline (prior to randomisation) and at all follow-up time points (10-weeks, 20-weeks & 32-weeks after randomisation)
Secondary outcome [3] 419782 0
Psychological flexibility measured by the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
Timepoint [3] 419782 0
Baseline (prior to randomisation), and 20 & 32-weeks after randomisation
Secondary outcome [4] 419783 0
Severity of physical symptoms, measured by a participant self-report DSCATT symptom and behaviour scale developed by our research group
Timepoint [4] 419783 0
Baseline (prior to randomisation) and at all follow-up time points (10-weeks, 20-weeks & 32-weeks after randomisation)
Secondary outcome [5] 419784 0
Depression symptoms measured by the 21-item Depression Anxiety Stress Scale (DASS-21) - depression subscale
Timepoint [5] 419784 0
Baseline (prior to randomisation) and at all follow-up time points (10-weeks, 20-weeks & 32-weeks after randomisation)
Secondary outcome [6] 419785 0
Severity of illness rated by the trial therapists via the transdiagnostic Clinical Global Impression (T-CGI) severity subscale
Timepoint [6] 419785 0
Completed by the trial therapist after the participant's initial session, and repeated after the participant's 16th treatment session.
Secondary outcome [7] 420087 0
Severity (PGI-S) of physical symptoms rated by the participant on the Patient Global Impression scale (PGI)
Timepoint [7] 420087 0
Baseline (prior to randomisation) and all follow-up time points (10, 20 & 32-weeks post randomisation)
Secondary outcome [8] 420088 0
Participant experiences of the treatment program (including perceived value and views regarding its effects on their illness, overall health and wellbeing) completed via a one-on-one semi-structured interview facilitated by study staff not involved in delivery of the intervention.
Timepoint [8] 420088 0
Completed 20-weeks post randomisation
Secondary outcome [9] 420089 0
Safety of the intervention measured by the Negative Effects Questionnaire (NEQ)
Timepoint [9] 420089 0
Completed by participants 20-weeks post randomisation
Secondary outcome [10] 420090 0
Safety of the intervention measured by the number of adverse events reported by participants, or observed by the trial clinicians, in the ACT-based group in comparison to waitlist controls
Timepoint [10] 420090 0
Adverse events will be reviewed by the trial clinician in each treatment session; waitlist control participants will be contacted by the project manager 10-weeks and 20-weeks post randomisation to review for the occurrence of adverse events.
Secondary outcome [11] 420096 0
Feasibility of collecting health service use via i) participant completion rates on a resource use questionnaire (RUQ) developed by the researchers and ii) the number of participants who consent to MBS/PBS data access for study purposes.
Timepoint [11] 420096 0
The RUQ will be provided to participants at baseline (prior to randomisation), and 20 & 32-weeks post randomisation. Participants will be asked to provide consent to MBS/PBS data access when they consent to study participation.
Secondary outcome [12] 420097 0
Feasibility of our screening process to identify suitable candidates for the trial informed by the number of participants who are screened and deemed eligible for the trial (eligibility rate). These figures will be recorded by the project coordinator in the study 'inquiry & pre-screening log' whilst recruitment for the trial is open.
Timepoint [12] 420097 0
The project manager will tabulate the number of people who are screened and deemed eligible for the trial whilst recruitment is open, up until conclusion of the study.
Secondary outcome [13] 420366 0
Change in symptom severity rated by the participant on the Patient Global Impression-Improvement scale (PGI-I)
Timepoint [13] 420366 0
All follow-up time points (10, 20 & 32-weeks post randomisation)
Secondary outcome [14] 420367 0
Change in illness severity rated by the trial therapist via the transdiagnostic Clinical Global Impression (T-CGI) improvement sub-scale
Timepoint [14] 420367 0
Completed by the trial therapist after the participant's 16th treatment session
Secondary outcome [15] 420368 0
Anxiety symptoms measured by the 21-item Depression Anxiety Stress Scale (DASS-21) - anxiety subscale
Timepoint [15] 420368 0
Baseline (prior to randomisation) and at all follow-up time points (10-weeks, 20-weeks & 32-weeks after randomisation)
Secondary outcome [16] 420369 0
Stress symptoms measured the 21-item Depression Anxiety Stress Scale (DASS-21) - stress subscale
Timepoint [16] 420369 0
Baseline (prior to randomisation) and at all follow-up time points (10-weeks, 20-weeks & 32-weeks after randomisation)

Eligibility
Key inclusion criteria
i. Able to consent to the study
ii. Possess English sufficient to understand and engage with the therapy
iii. Access to Telehealth facilities, or able to attend on site at the Austin Hospital
iv. >17 years of age
v. Able to pause any existing psychological therapies during the treatment intervention
vi. Meet the following case definition for DSCATT:
a) DSCATT requires evidence of a tick bite which must be either:
i. subject report of an observed tick bite (though symptoms may not develop for several months afterwards) OR
ii. serological results from a NATA-accredited laboratory consistent with previous infection (i.e. detection of pathogen-specific IgG) with a tick-transmitted pathogen, for example, Rickettsia, Q-fever, Babesia, Anaplasma, Borrelia, or tick-borne encephalitis virus
b) DSCATT can be acquired in Australia or overseas
c) DSCATT must involve symptoms in three or more systems (cardiovascular, musculoskeletal, neurological, etc.), which must include fatigue and a cognitive symptom
d) DSCATT symptoms can be mild, but must be present for at least six months, including relapse and remission, and must impact everyday activities
e) DSCATT can develop following one or more diagnosed infections, or without diagnosed infection
f) DSCATT is excluded by other medical conditions which better explain the symptoms, but not by abnormal tests in isolation, nor by other medically unexplained syndromes

Note, this case definition was developed in 2022 and updated in 2024 following a modified Delphi process facilitated by our research group involving patient representatives, clinicians and scientists familiar with DSCATT (N = 11).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Current psychotic disorder
ii. Diagnosis of a medical condition which better explains the participant’s symptoms (excluding medically unexplained syndromes/functional disorders)

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)
Participants will be individually randomised 1:1 to the ACT-based therapy or the waitlist control arm. A randomly permuted block randomisation list will be computer-generated by an independent statistician, stratified by female/male.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A detailed statistical analysis plan describing the analysis of the feasibility and clinical outcomes will be prepared prior to unblinding the database for analysis. All outcomes will be summarised overall or by treatment arm. Descriptive statistics will consist of numbers and percentages for categorical variables. Mean and standard deviation (SD) or median and interquartile range (IQR) will be reported for continuous variables. The frequency and percentage of participants with missing data will be provided for all outcomes. Following a mixed-methods convergent parallel design, quantitative data and qualitative data will be analysed separately and results compared to identify how they confirm, contradict or expand upon each other.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/07/2023
Actual
26/07/2023
Date of last participant enrolment
Anticipated
26/11/2024
Actual
Date of last data collection
Anticipated
29/07/2025
Actual
Sample size
Target
120
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 24305 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 39857 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 313424 0
Government body
Name [1] 313424 0
National Health and Medical Research Council (NHRMC)
Country [1] 313424 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 315191 0
None
Name [1] 315191 0
None
Address [1] 315191 0
Country [1] 315191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312637 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 312637 0
Ethics committee country [1] 312637 0
Australia
Date submitted for ethics approval [1] 312637 0
13/02/2023
Approval date [1] 312637 0
11/05/2023
Ethics approval number [1] 312637 0

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

Contacts
Principal investigator
Name 125374 0
Prof Richard Kanaan
Address 125374 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 125374 0
Australia
Phone 125374 0
+61 3 9496 3351
Fax 125374 0
Email 125374 0
[email protected]
Contact person for public queries
Name 125375 0
Georgina Oliver
Address 125375 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 125375 0
Australia
Phone 125375 0
+61 3 8344 0189
Fax 125375 0
Email 125375 0
[email protected]
Contact person for scientific queries
Name 125376 0
Richard Kanaan
Address 125376 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 125376 0
Australia
Phone 125376 0
+61 3 9496 3351
Fax 125376 0
Email 125376 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?
De-identified data from participants who have provided extended consent for data sharing as per the study Participant Information & Consent Form (PICF)
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Available for projects which are "(i) an extension of, or closely related to, the original project; or (ii) in the same general area of research” that have received approval from a registered HREC committee
Available for what types of analyses?
Any purpose
How or where can data be obtained?
A metadata listing will be created in The University of Melbourne’s Melbourne Academic Centre for Health (MACH) figshare repository outlining the type of data available and requirements to follow before it can be shared (e.g. receipt of HREC approval letter to conduct the project).


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.