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Trial registered on ANZCTR


Registration number
ACTRN12622001464752
Ethics application status
Approved
Date submitted
1/11/2022
Date registered
18/11/2022
Date last updated
18/11/2022
Date data sharing statement initially provided
18/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exposure Therapy for Functional Neurological Disorders
Scientific title
Exposure Therapy for Functional Neurological Disorders - an open-label, prospective, randomised, wait-list controlled, feasibility pilot study
Secondary ID [1] 308282 0
None
Universal Trial Number (UTN)
Trial acronym
ET-FND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Neurological Disorders 328067 0
Condition category
Condition code
Neurological 325127 325127 0 0
Other neurological disorders
Mental Health 325270 325270 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot trial will assess the efficacy of Skills Training in Affective and Interpersonal Regulation (STAIR) in Functional Neurological Disorders (FND). STAIR is an established psychological treatment for Posttraumatic Stress Disorder (PTSD). STAIR Therapy consists of two separate phases: the skills-focused STAIR phase (8 sessions) and the trauma exposure phase (8 sessions). The STAIR phase of treatment is dedicated to interventions designed to target emotional regulation and social impairments. Specifically, skills aimed to enhance emotion regulation capacities and improve interpersonal effectiveness are taught and fostered over the course of eight sessions. The second phase of treatment introduces the creation of a series of narratives where clients are asked to provide a description of traumatic experiences out loud in a detailed, organized and emotionally engaged fashion. This phase of treatment is implemented in the individual format. Skills practice continues throughout the second phase and successes in day-to-day events are discussed to highlight differences between traumatic events being described and life in the “here and now.” Emotion regulation skills are employed during the narrative work as needed. Successful progression through treatment allows for the meaningful reorganization of traumatic memories and reinforces the emotion regulation skills work completed in the initial STAIR phase. The treatment goals and associated interventions in the STAIR phase include (1) promoting emotional awareness through the identification and labeling of feelings and their triggers as they emerge in daily life; (2) teaching emotion regulation strategies to modulate negative feelings and tolerate distress via adaptive affective expression through actions, words and thoughts; (3) fostering the adaptive use of emotions and distress tolerance to facilitate achievement of social goals; (4) encouraging the identification and modification of maladaptive interpersonal schemas that are influencing interpersonal functioning; (5) facilitating the identification of adaptive and achievable social goals in the context of different types of relationships and interpersonal situations; and (6) attaining a sense of emotional and social self-efficacy that facilitates living in the world with compassion and empathy. Participants will be encouraged to complete 'homework' tasks each week. This includes breathing retraining taught in the first session of STAIR (target practice 5 minutes, twice daily); completion of a 'feelings monitoring form' (completed minimum twice daily for minimum 1-week, 2-3 minutes per completion), interpersonal schema worksheet (completed over two weeks, 20-30 mins in total); listening to a recording of an exposure narrative completed with the therapist in a treatment session (listen to recording once daily for 1-week).

In this study, treatment will involve 16, one hour sessions completed over 16-weeks. All sessions will take place face-to-face at the Neuropsychology East Melbourne clinic located in Victoria, or via Telehealth so people from regional areas and interstate can participate. All 16 sessions (including those in the STAIR phase) will be conducted one-to-one by a psychologist trained in this model of therapy following a therapist manual (resource adapted from Cloitre M et al., 2002, Skills training in affective and interpersonal regulation followed by exposure). Clinical supervision will be overseen by Prof Sarah Wilson and Prof Kim Felmingham who collectively are highly experienced working with this patient group and in STAIR Therapy.

Therapist adherence to the intervention will gauged via 1) completion of a session checklist (completed by the trial therapist) to ensure treatment targets are met; and 2) independent assessment of audio recordings of each treatment session completed with participants.
Intervention code [1] 324735 0
Treatment: Other
Intervention code [2] 324871 0
Behaviour
Comparator / control treatment
Wait-list control group. The control group involves FND patients who will be randomly allocated to a 16-week wait list and continue their standard care as usual. After this time, they will then be offered the same intervention as the treatment group.
Control group
Active

Outcomes
Primary outcome [1] 332944 0
Clinician-Rated Global Assessment of Functioning (GAF-C)
Timepoint [1] 332944 0
Completed by the treating clinician (psychologist) at Baseline and 16-weeks later (coinciding with the end of the intervention/wait-list control)
Secondary outcome [1] 415256 0
Participant rated quality of life assessed via the EQ-5D
Timepoint [1] 415256 0
Baseline (just prior to randomisation into the treatment/waitlist control group) and 4, 8, 12 and 16 weeks after baseline
Secondary outcome [2] 415257 0
Depression and anxiety symptoms assessed via participant self report on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 415257 0
Baseline (just prior to randomisation into the treatment/waitlist control group) and 4, 8, 12 and 16 weeks after baseline
Secondary outcome [3] 415259 0
Quality of life assessed via participant self-report on the Short-form 36 Health Survey (SF36)
Timepoint [3] 415259 0
Baseline (just prior to randomisation into the treatment/waitlist control group) and 4, 8, 12 and 16 weeks after baseline
Secondary outcome [4] 415260 0
Participant self-rated Global Assessment of Functioning (GAF)
Timepoint [4] 415260 0
Baseline (just prior to randomisation into the treatment/waitlist control group) and 4, 8, 12 and 16 weeks after baseline
Secondary outcome [5] 415261 0
Self reported seizure frequency (for individuals who experience seizures as part of their FND)
Timepoint [5] 415261 0
Baseline (just prior to randomisation into the treatment/waitlist control group) and 4, 8, 12 and 16 weeks after baseline
Secondary outcome [6] 415322 0
Feasibility of the trial measured by a composite of:
a) Proportion of patients who are screened and deemed eligible to participate
b) Willingness of patients to be consented and randomised
c) Number of therapy sessions attended by participants

Timepoint [6] 415322 0
a) A research assistant, in conjunction with the chief investigator, will collate these figures whilst the trial is recruiting
b) A research assistant, in conjunction with the chief investigator, will collate the number of participants who consent and are randomised into the trial
c) the trial psychologist will record attendance rates to the sessions throughout the
intervention period

Eligibility
Key inclusion criteria
• A diagnosis of FND by DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria
• Identified trauma preceding symptom onset within the last 5 years – this will be determined by the use of the Life Events and Difficulties Schedule (LEDS) administered by study staff prior to participant randomisation into the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not fluent in English
• Unable to give informed consent
• Under 18 years of age
• Cognitive impairment
• Drug or Alcohol use disorder
• Currently undertaking psychological therapy

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1-1 at the point of recruitment by the chief investigator to intervention or waiting list followed by the intervention. A randomisation table created by computer software (i.e. computerised sequence generation) will be used to develop the sequence generation (simple randomisation method).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis plan will be agreed before unblinding of the database based on the study protocol. All analyses for all the outcomes will include all randomised patients. The feasibility parameters will be estimated by relevant summary statistics. For example, the proportion of eligible patients who agree to be randomised will be estimated by the relative frequency of patients agreeing to randomisation once confirmed eligible. Feasibility parameter estimates will be accompanied by 95% CIs. Treatment differences between the intervention and control will be explored. For continuous outcomes, mean differences between the intervention and treatment as usual will be estimated (including 95% CI) at week 16 and at follow-up using a linear regression model that accounts for baseline. Outcomes with a right skewed distribution will be log transformed first before fitting this model. For binary outcomes, we will use log-binomial regression to estimate risk ratios (including 95% CIs) at week 16 and follow-up. Missing scale item data will be handled as per questionnaire specific recommendations. Missing data reasons and the proportion of missing data in the outcomes will be compared between arms. The number and proportion of patients with (serious) adverse events will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23466 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 38870 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 312531 0
Hospital
Name [1] 312531 0
Austin Health (Austin Medical Research Fund)
Country [1] 312531 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 314130 0
None
Name [1] 314130 0
Address [1] 314130 0
Country [1] 314130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311864 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 311864 0
Ethics committee country [1] 311864 0
Australia
Date submitted for ethics approval [1] 311864 0
Approval date [1] 311864 0
28/07/2021
Ethics approval number [1] 311864 0
HREC/69935/Austin-2020

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

Contacts
Principal investigator
Name 122642 0
Prof Richard Kanaan
Address 122642 0
Level 10, Lance Townsend Building
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Country 122642 0
Australia
Phone 122642 0
+61394963351
Fax 122642 0
Email 122642 0
richard.kanaan@unimelb.edu.au
Contact person for public queries
Name 122643 0
Richard Kanaan
Address 122643 0
Level 10, Lance Townsend Building
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Country 122643 0
Australia
Phone 122643 0
+61394963351
Fax 122643 0
Email 122643 0
richard.kanaan@unimelb.edu.au
Contact person for scientific queries
Name 122644 0
Richard Kanaan
Address 122644 0
Level 10, Lance Townsend Building
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Country 122644 0
Australia
Phone 122644 0
+61394963351
Fax 122644 0
Email 122644 0
richard.kanaan@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not provided consent for data sharing


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.