None listed
Conditions
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”. They described this patient group as having Debilitating Symptom Complexes Attributed to Ticks (DSCATT). The precise scale of DSCATT is at present unknown, though it is believed there are large numbers affected, and that their morbidity is profound. After extensive medical investigations, individuals with DSCATT are often left without a clear explanation for their illness, nor do they feel that their symptoms and level of impairment are believed by many healthcare providers. Collectively, this can lead to further distress and perpetuate their disease process and disability. There are no recognised treatments for DSCATT at present, however, there has been much research into treatments for other medically unexplained and contested illnesses. An increasing body of evidence shows that psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life in such conditions. This project will explore the feasibility of an ACT informed intervention which has been tailored to suit the needs of this patient group. We have elected to complete a feasibility trial given there are no published clinical trials or cases reports which investigate potential treatments for DSCATT at present, including psychology-based approaches. As such, there is uncertainty surrounding the demand for, and acceptability of this type of treatment approach for DSCATT. Therefore, we wish to assess if our therapy is acceptable, practical, and in demand for patients with DSCATT before a larger scale, treatment efficacy trial is conducted. Completion of this feasibility trial may also assist in identifying an appropriate primary outcome measure by exploring the therapy’s potential mechanism of actions and perceived value to participants. The study will utilise quantitative and qualitative data collection methods to address its study aims (feasibility, effects on health-related outcomes, and safety and tolerability) following a mixed-methods, parallel convergent design.
Interventions
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 (v
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.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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)
Outcome results
None listed