None listed
Conditions
Brief summary
The main purpose of the study is to see if the treatment improves physical functioning in people with functional neurological symptoms - in other words, reduces or eliminates their symptoms. The treatment starts with a session with a psychologist, who listens to the patient's situation, and then explains why their symptoms might have started in the first place, and why they are still there. The patient then receives physical therapy sessions, e.g. focusing on getting their affected limbs moving again. Patients are distracted at certain times (e.g. with music) to see if that helps start to reduce symptoms. They are encouraged to attempt more and more difficult physical tasks as they start to recover.
Interventions
The current intervention is based on the idea that functional neurological symptoms occur as the result of a nocebo effect. In other words, a subconscious belief/representation of being neurologically damaged produces symptoms.
The intervention is administered on an individual basis. It includes an explanation of the “nocebo hypothesis” to the patients within the context of a personalised psychosocial formulation of their symptoms by a clinical psychologist. Physical therapy then follows, incorp
The current intervention is based on the idea that functional neurological symptoms occur as the result of a nocebo effect. In other words, a subconscious belief/representation of being neurologically damaged produces symptoms. The intervention is administered on an individual basis. It includes an explanation of the “nocebo hypothesis” to the patients within the context of a personalised psychosocial formulation of their symptoms by a clinical psychologist. Physical therapy then follows, incorporating video recording and feedback to show the patient that their functioning can improve when they are distracted (e.g. by music). These therapy elements are designed in order to weaken people's belief that they are neurologically damaged, and give a clear alternative explanatory account of causation. The physical therapy elements of the treatment will be delivered by rehabilitation professional, including a physiotherapist. Patients will receive written information about their diagnosis and treatment, consistent with the education given to them. Dependent on individual patient need (e.g. type and severity of symptoms), the following equipment may potentially be used: mobility aids (e.g. walking frame), parallel bars, treadmill, portable electromyography biofeedback unit. The intervention will be delivered face to face over 8 weeks (minimum of 3 hours up to a maximum of 25 hours total duration, session duration 45 - 90 minutes). The frequency and scheduling will depend on the patient’s stamina and needs. Sessions will follow a standardized script/format and will be part of either an inpatient or outpatient treatment. All therapists in this trial have to study a therapy manual and receive a training in the treatment content and procedure. Therapists are required to attend supervision frequently with a licensed supervisor experienced in CBT for patients with functional neurological symptoms. All initial therapy sessions will be video-taped, and the first physical therapy session will also be audio-taped. We will design a rating scale to assess treatment fidelity and its two components, therapist adherence and treatment specificity, for both the NH-CBT and the control intervention. We will assess therapist competence with a validated rating scale. Session records of a randomly selected sample (30% of the intention-to-treat [ITT] sample) will be rated by an independent, blinded rater. The majority of sessions will occur at the ISIS (Rehabilitation) Centre, Wakari Hospital, Dunedin, for both inpatient and outpatient treatment, although some sessions will occur in community settings for some patients, predominantly when they are in the latter stages of treatment.
Sponsors
Dr Matt Richardson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients that will be included in our trial will have to meet the following criteria: • aged 18 or older • have been assessed by a neurologist including the appropriate medical investigation (e.g. imaging), and that assessment will have resulted in a formal diagnosis of FNSD (i.e. they meet DSM-V diagnostic criteria), or will have clearly identified functional neurological symptoms (according to Fahn-Williams / Gupta-Lang criteria). • have consented to participate
Exclusion criteria
Patients will be excluded from the trial if they meet the following criteria: • they have a diagnosis of complex regional pain syndrome (CRPS) • they have a diagnosis of Dissociative Identity Disorder (DID) • they have a diagnosis of Post-Traumatic Stress Disorder (PTSD) with high severity and significant dissociation. • they require inpatient mental health treatment during the trial. • they receive psychopharmacotherapy and change their treatment regimen from four weeks before baseline assessment until the final assessment. • according to the clinical judgement of the lead investigator, there are concerns about their ability to participate fully in the trial, e.g. they have active and extensive self-harm, or frequent admissions for inpatient mental health treatment in the last two months • they sustain significant physical trauma during the period of the trial (inside or outside of the treatment setting), and therefore cannot participate in the physical therapy. • their English language proficiency is low. • they do not have the capacity to consent to participating in the trial • they have previously received either NH-CBT or the active control treatment
Outcome results
None listed