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Exposure Therapy for Functional Neurological Disorders

Exposure Therapy for Functional Neurological Disorders - an open-label, prospective, randomised, wait-list controlled, feasibility pilot study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001464752
Acronym
ET-FND
Enrollment
12
Registered
2022-11-18
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Functional Neurological Disorders (FND) are neurological problems that are thought to have a psychiatric cause. Though they are very common - the commonest reason for a referral to a neurologist – and very disabling, we know very little about how to treat them. This study would try out a new treatment – or rather, try out a very old treatment that has never been tested for FND before. Sigmund Freud proposed, 120 years ago, that FND (then known as hysteria) were a post-traumatic disorder - an abnormal reaction to stressful life events - and that the way to treat them was by getting patients to fully experience their traumatic memories, rather than avoiding them. This proved to be the best way to treat post-traumatic stress disorder (PTSD), in what is known as ‘prolonged exposure therapy’. However, it has never really been tested for FND, probably because deciding what the traumas are is difficult. In PTSD it is easy, because the traumas are life-threatening events, such as those that occur in warfare; in FND it is hard, because the traumas are less dramatic, such as a fight with a spouse or being bullied by your boss. We have developed a method for identifying these traumas in FND, and have confirmed that FND is a post-traumatic disorder – symptoms began following a traumatic life event in over 90% of cases. The next step is to see if the treatment that works so well for PTSD will work in FND. We propose to adapt the standard therapy by incorporating our method of identifying the traumas in FND, and then performing exposure therapy on those traumas. We will recruit patients from FND services at Austin Health, and then randomly allocate them to 16 sessions of exposure therapy, or a waiting list control. We will then compare the symptoms and quality of life in our patients at the beginning and end of the therapy to see if it has made a difference, when compared to the controls. We will then offer the same therapy to those on the waiting list. If successful, it will form the pilot for a larger grant for a full-scale trial of the therapy, and would represent an historic breakthrough in the management of this ancient condition.

Interventions

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 impairment

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.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026