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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]

None

Universal Trial Number (UTN)

Trial acronym

ET-FND

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Functional Neurological Disorders

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

Clinician-Rated Global Assessment of Functioning (GAF-C)

Timepoint [1]

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]

Participant rated quality of life assessed via the EQ-5D

Timepoint [1]