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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
2/06/2023
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)
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Scientific title
Feasibility and acceptability of an Acceptance and Commitment Therapy (ACT) informed intervention for Debilitating Symptom Complexes Attributed to Ticks (DSCATT)
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Secondary ID [1]
304422
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Debilitating Symptom Complexes Attributed to Ticks (DSCATT)
322228
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Condition category
Condition code
Other
319920
319920
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
320778
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Numbers will be tabulated at conclusion of the study
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Primary outcome [2]
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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.
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Assessment method [2]
327796
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Timepoint [2]
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Within one month of completing/exiting the treatment intervention
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Primary outcome [3]
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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.
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Assessment method [3]
328087
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Timepoint [3]
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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).
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Secondary outcome [1]
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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).
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Assessment method [1]
396617
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Timepoint [1]
396617
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Baseline, and every 4-weeks since commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
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Secondary outcome [2]
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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.
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Assessment method [2]
397543
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Timepoint [2]
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Baseline, and 12-weeks after commencing treatment at treatment end-point (Week-12)
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Secondary outcome [3]
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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.
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Assessment method [3]
397550
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Timepoint [3]
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Baseline, and 12-weeks after commencing treatment at treatment end-point (Week-12)
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Secondary outcome [4]
397554
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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.
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Assessment method [4]
397554
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Timepoint [4]
397554
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Baseline only
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Secondary outcome [5]
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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.
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Assessment method [5]
397556
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Timepoint [5]
397556
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Baseline, and every 4-weeks after commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
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Secondary outcome [6]
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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.
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Assessment method [6]
397558
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Timepoint [6]
397558
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Baseline, and every 4-weeks after commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
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Secondary outcome [7]
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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.
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Assessment method [7]
397564
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Timepoint [7]
397564
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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).
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Secondary outcome [8]
397565
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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.
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Assessment method [8]
397565
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Timepoint [8]
397565
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Baseline, and 12-weeks after commencing treatment at treatment end-point (Week-12)
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Secondary outcome [9]
397566
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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
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Assessment method [9]
397566
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Timepoint [9]
397566
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Baseline, and every 4-weeks since commencing treatment until treatment end-point (i.e. Week-4, Week-8 and Week-12)
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Secondary outcome [10]
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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.
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Assessment method [10]
397571
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Timepoint [10]
397571
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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.
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Secondary outcome [11]
397575
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*Primary outcome (4)* Number of participants who withdraw from the study (retention rates after baseline)
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Assessment method [11]
397575
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Timepoint [11]
397575
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Recorded by the project coordinator/therapists as withdrawals occur during the study
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Secondary outcome [12]
397576
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*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.
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Assessment method [12]
397576
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Timepoint [12]
397576
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Numbers will be tabulated at conclusion of the study
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Secondary outcome [13]
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Completion rates of study questionnaires (i.e. HMQ, PGI, WSAS, AQoL-8D etc.)
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Assessment method [13]
397849
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Timepoint [13]
397849
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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)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/08/2021
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Actual
4/10/2021
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Date of last participant enrolment
Anticipated
19/10/2021
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Actual
22/03/2022
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Date of last data collection
Anticipated
28/06/2022
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Actual
30/06/2022
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Sample size
Target
12
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
19653
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
34285
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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414 La Trobe St, Melbourne VIC 3000
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Country [1]
308787
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
145 Studley Rd, Heidelberg VIC 3084
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Country
Australia
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Secondary sponsor category [1]
309703
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None
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Name [1]
309703
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Address [1]
309703
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Country [1]
309703
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308699
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
308699
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Austin Hospital, 145 Studley Rd, Heidelberg, VIC, 3084
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Ethics committee country [1]
308699
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Australia
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Date submitted for ethics approval [1]
308699
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01/10/2020
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Approval date [1]
308699
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26/02/2021
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Ethics approval number [1]
308699
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HREC/69382/Austin-2020
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Richard Kanaan
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Address
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Level 10, Lance Townsend Building
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
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Country
111602
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Australia
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Phone
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+61394963351
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Fax
111602
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Email
111602
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[email protected]
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Contact person for public queries
Name
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Georgina Oliver
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Address
111603
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Level 10, Lance Townsend Building
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
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Country
111603
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Australia
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Phone
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+61 3 83440189
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Fax
111603
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Email
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[email protected]
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Contact person for scientific queries
Name
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Georgina Oliver
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Address
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Level 10, Lance Townsend Building
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
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Country
111604
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Australia
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Phone
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+61 3 83440189
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Fax
111604
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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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.
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Available to whom?
Other researchers who are investigating DSCATT and/or related conditions
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Available for what types of analyses?
Analyses which have been approved by a registered HREC.
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How or where can data be obtained?
Please contact the Principal Investigator via email
[email protected]
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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.
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