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Trial registered on ANZCTR


Registration number
ACTRN12621001032842
Ethics application status
Approved
Date submitted
8/06/2021
Date registered
5/08/2021
Date last updated
5/08/2021
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot testing a psychology-based treatment intervention for Debilitating Symptom Complexes Attributed to Ticks (DSCATT)
Scientific title
Feasibility and acceptability of an Acceptance and Commitment Therapy (ACT) informed intervention for Debilitating Symptom Complexes Attributed to Ticks (DSCATT)
Secondary ID [1] 304422 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Debilitating Symptom Complexes Attributed to Ticks (DSCATT) 322228 0
Condition category
Condition code
Other 319920 319920 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
A 12-week open label, single centre, pilot study exploring the feasibility and acceptability of a tailored psychology-based intervention (Acceptance and Commitment Therapy; ACT) in adults (18 years of age and over) who have Debilitating Symptom Complexes Attributed to Ticks (DSCATT). The treatment incorporates principles of ACT which has been shown to improve quality of life and well being in patients with Medically Unexplained Syndromes (MUS) and other chronic illnesses (e.g., cancer, acquired brain injury, chronic pain). It aims to equip patients with practical skills to manage the physical discomfort and psychological distress associated with DSCATT, so that they can take effective action to live according to their values even in the face of persistent illness. The treatment can be flexibly adapted to meet each participant's individual needs (as identified with the study clinician), and also includes modules for improving sleep, addressing difficulties with concentration and memory, as well as navigating social relationships.

The treatment intervention will be delivered, one-one-one (i.e. 1 patient with 1 therapist per session) by a clinical/health/neuropsychologist and/or allied health clinician (study clinician) trained in this model of ACT (training and supervision will be facilitated by investigators Prof Chalder, Kanaan & Wilson), and will be adjunctive to the participant’s current treatment/s. The participant will meet with the study clinician for an hour, once/week for 12 weeks and treatment will be guided by a purpose designed therapist manual and corresponding patient workbook (formulated by Prof Wilson & Prof Chalder & the study clinicians). Participants will be encouraged to engage with between-session tasks and practice of skills introduced in sessions, which is estimated to take an additional 1-2 hour per week. Treatment adherence (visits attended) will be recorded by the study clinicians and sessions will be audio recorded to assess fidelity and for training purposes.

The intervention will be individualised in the following ways - behaviour and/or cognitions that are the therapeutic focus will be patient led, therefore individualised according to what the participant feels is the most pressing issue/problem for them. This will ensure that the intervention is targeting the most pertinent issue/s the participant is facing and guide the order of delivery for each module within the intervention, i.e. contingent on where the participant is currently at in their recovery. This 'tailoring' will predominately occur between sessions 6-10 when more individualised modules (addressing particular domains of life or specific skills) are introduced.

The therapy will be offered face-to-face at the Austin Hospital, Melbourne, VIC (subject to DHHS/hospital restrictions), or via Telehealth to accommodate participants who live interstate or who are unable to travel on site.
Intervention code [1] 320778 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327795 0
Feasibility and acceptability of the study assessed using the number of participants who are consented and enrolled into the study.

These figures will be recorded by the project coordinator, who will liaise with the study clinicians where necessary.
Timepoint [1] 327795 0
Numbers will be tabulated at conclusion of the study
Primary outcome [2] 327796 0
Participant reported acceptability of the treatment.

Participant's experiences and attitudes towards treatment will be explored via a one-on-one, audio recorded, qualitative interview with the project coordinator. A semi-structured interview guide will be employed to facilitate the interview consisting of a broad, open-ended initial question, followed by targeted probes and general probes to be used thereafter as required.
Timepoint [2] 327796 0
Within one month of completing/exiting the treatment intervention
Primary outcome [3] 328087 0
Feasibility and acceptability of the study assessed using attendance rates to therapy (treatment) sessions, as well as the participants' willingness to use the strategies explored in therapy.
Timepoint [3] 328087 0
Explored and recorded by the study clinicians (therapists) from the participant's first session, and at each weekly session thereafter until treatment end-point (Week-12).
Secondary outcome [1] 396617 0
Assessment of Quality of Life 8 Dimension (AQoL-8D), a 35-item, self-reported measure which assess quality of life across the following domains: Independent Living, Happiness, Mental Health, Coping, Relationships, Self-Worth, Pain, Senses (e.g. vision, hearing).

Timepoint [1] 396617 0
Baseline, and every 4-weeks since commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
Secondary outcome [2] 397543 0
Cognitive Behavioural Responses Questionnaire – short version (CBRQ-S), an 18-item self-reported measure which captures patient’s cognitive and behavioural responses regarding their illness and physical symptoms.
Timepoint [2] 397543 0
Baseline, and 12-weeks after commencing treatment at treatment end-point (Week-12)
Secondary outcome [3] 397550 0
Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT), a 23-item self-reported measure used to assess Acceptance and Commitment Therapy (ACT) processes related to psychological flexibility.
Timepoint [3] 397550 0
Baseline, and 12-weeks after commencing treatment at treatment end-point (Week-12)
Secondary outcome [4] 397554 0
Credibility/Expectancy Questionnaire (CEQ), a brief, 6-item, self-reported instrument designed to capture a person’s “beliefs” about treatment, including cognitive and affective components of their belief systems.
Timepoint [4] 397554 0
Baseline only
Secondary outcome [5] 397556 0
The Horowitz Multiple Systemic Infectious Disease Syndrome (MSIDS) Questionnaire (HMQ), a self-reported measure which assesses the presence and severity of symptoms commonly seen in tick borne illness and other chronic diseases.
Timepoint [5] 397556 0
Baseline, and every 4-weeks after commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
Secondary outcome [6] 397558 0
The Hospital Anxiety And Depression Scale (HADS), a 14-item, self-reported measure which assesses the severity of different symptoms consistent in depressive and anxiety disorders.
Timepoint [6] 397558 0
Baseline, and every 4-weeks after commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
Secondary outcome [7] 397564 0
Patient Global Impression (PGI) scale, a brief, self-reported measure which asks participants to rate the severity of their illness and perceived improvement during the treatment intervention.
Timepoint [7] 397564 0
Baseline (severity sub-scale only), and every 4-weeks since commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12).
Secondary outcome [8] 397565 0
A purpose designed Resource Use Questionnaire (Deakin University) which captures healthcare services used within the previous 3 months. The questionnaire also explores absenteeism (e.g. from work, studies, other responsibilities) and impaired functioning due to the participant's illness.
Timepoint [8] 397565 0
Baseline, and 12-weeks after commencing treatment at treatment end-point (Week-12)
Secondary outcome [9] 397566 0
Work and Social Adjustment Scale (WSAS), a brief, 5-item, self-reported measure which captures perceived impact of illness on functioning in terms of work, home management, social leisure and private leisure activities, family and other relationships
Timepoint [9] 397566 0
Baseline, and every 4-weeks since commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
Secondary outcome [10] 397571 0
Clinical Global Impression (CGI) scale, a brief, clinician rated instrument which assess the severity of the participant's illness, and perceived improvement during the treatment intervention period.
Timepoint [10] 397571 0
The CGI will be rated by the project coordinator at baseline (severity sub-scale only) and post treatment intervention after completion of the qualitative interview.
Secondary outcome [11] 397575 0
*Primary outcome (4)* Number of participants who withdraw from the study (retention rates after baseline)
Timepoint [11] 397575 0
Recorded by the project coordinator/therapists as withdrawals occur during the study
Secondary outcome [12] 397576 0
*Primary outcome (5)* Feasibility of the study assessed using the number of inquiries for study participation (pre-enrolment).

All inquires regarding study participation (e.g. emails, phone calls) will be recorded by the project coordinator.
Timepoint [12] 397576 0
Numbers will be tabulated at conclusion of the study
Secondary outcome [13] 397849 0
Completion rates of study questionnaires (i.e. HMQ, PGI, WSAS, AQoL-8D etc.)
Timepoint [13] 397849 0
The project coordinator will record the number of participants who complete study questionnaires (sent electronically via REDCap software) at Baseline, and every 4-weeks since commencing treatment until treatment endpoint (i.e. Week-4, Week-8 and Week-12)

Eligibility
Key inclusion criteria
(i) Are greater than or equal to 18 years of age
(ii) Identify as having DSCATT (a chronic illness, >6 months, attributed to tick bite/s, which cannot be better explained by another medical condition)
(iii) Able to provide written informed consent
(iv) Can speak and read English at a level adequate for participation in therapy
(v) Have adequate internet connection to facilitate telehealth appointments where necessary
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) active psychosis (as per The Mini International Neuropsychiatric Interview, MINI, V7 and/or clinician assessment);
(ii) drug or alcohol abuse (as per MINI v7);
(iii) current benzodiazepine use exceeding the equivalent of 10mg diazepam/day;
(iv) are at imminent risk of suicide or self-harm to self or others (as per MINI v7 and/or clinician assessment)
(v) A serious and/or unstable medical condition/s that may interfere with participating in the study, to be determined on a case-by-case basis by the medical investigators

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Descriptive statistics will be used to analyse the outcome measures (enrollment rates, retention rates, attendance etc.). The Revised Illness Perception Questionnaire (IPQ-R), provided to participants at baseline, will be used to assess if views regarding illness influence response to treatment. Regarding qualitative data (post treatment interviews), interviews will be audio-recorded, transcribed and analysed using NVIVO software. The project coordinator will listen to the recordings, transcribe them verbatim, and read the transcripts – data collection and analysis proceeding concurrently. Transcripts will be coded by question, and, iteratively, by emerging themes, consistent with a grounded theory approach. Themes will be inductively reviewed with the other investigators on an ongoing basis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 19653 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 34285 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 308787 0
Government body
Name [1] 308787 0
National Health and Medical Research Council (NHMRC)
Address [1] 308787 0
414 La Trobe St, Melbourne VIC 3000
Country [1] 308787 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 309703 0
None
Name [1] 309703 0
Address [1] 309703 0
Country [1] 309703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308699 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 308699 0
Austin Hospital, 145 Studley Rd, Heidelberg, VIC, 3084
Ethics committee country [1] 308699 0
Australia
Date submitted for ethics approval [1] 308699 0
01/10/2020
Approval date [1] 308699 0
26/02/2021
Ethics approval number [1] 308699 0
HREC/69382/Austin-2020

Summary
Brief summary
After a senate inquiry into Australian Lyme-like illness in 2016, the Australian Government released a position statement specifying that “there is a group of Australian patients suffering from the symptoms of a chronic debilitating illness, which many associate with a tick bite” and described this patient group as having Debilitating Symptom Complexes Attributed to Ticks (DSCATT). Following extensive investigations, individuals with DSCATT are usually left without a clear explanation for their illness which can lead to further distress and potentially perpetuate their disease process. Thus, DSCATT is considered a medically unexplained syndrome (MUS), and one, at current, without recognised effective treatments. There has, however, been much research into treatments for other MUS and other chronic illnesses, including specific psychology-based interventions.

The aims of this pilot study are to assess the feasibility and acceptability of a tailored, 12-week, psychology-based intervention (informed by Acceptance & Commitment Therapy; ACT) for patients with DSCATT. Specifically, we aim to explore DSCATT patients’:
a) willingness to participate in the study (e.g. inquiry, enrolment & retention rates);
b) willingness to be consented and enrolled;
c) willingness to use the strategies explored in therapy;
d) attendance of patients at therapy sessions;
e) follow-up and response rates to questionnaires (data collection measures)
f) explore their experiences and attitudes towards treatment, post intervention
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111602 0
Prof Richard Kanaan
Address 111602 0
Level 10, Lance Townsend Building
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Country 111602 0
Australia
Phone 111602 0
+61394963351
Fax 111602 0
Email 111602 0
richard.kanaan@unimelb.edu.au
Contact person for public queries
Name 111603 0
Ms Georgina Oliver
Address 111603 0
Level 10, Lance Townsend Building
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 111603 0
Australia
Phone 111603 0
+61 3 83440189
Fax 111603 0
Email 111603 0
georgina.oliver@unimelb.edu.au
Contact person for scientific queries
Name 111604 0
Ms Georgina Oliver
Address 111604 0
Level 10, Lance Townsend Building
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 111604 0
Australia
Phone 111604 0
+61 3 83440189
Fax 111604 0
Email 111604 0
georgina.oliver@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For participants who provide extended consent, non-identifiable data obtained from participant self-reporting questionnaires will be available to other researchers investigating DSCATT and/or related conditions.
When will data be available (start and end dates)?
After the primary paper from this study has been published, date to be determined. Data will be available in perpetuity.
Available to whom?
Other researchers who are investigating DSCATT and/or related conditions
Available for what types of analyses?
Analyses which have been approved by a registered HREC.
How or where can data be obtained?
Please contact the Principal Investigator via email richard.kanaan@unimelb.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results