A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol.

BACKGROUND: Coronavirus disease 2019 (COVID-19) results in debilitating long-term symptoms, often referred to as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), in a substantial subgroup of patients. One of the most prevalent symptoms following COVID-19 is severe fatigue. Prompt delivery of cognitive behavioural therapy (CBT), an evidence-based treatment that has shown benefit in reducing severe fatigue in other conditions, may reduce post-COVID-19 fatigue. Based on an existing CBT protocol, a blended intervention of 17 weeks, Fit after COVID, was developed to treat severe fatigue after the acute phase of infection with SARS-CoV-2. METHOD: The ReCOVer study is a multicentre 2-arm randomised controlled trial (RCT) to test the efficacy of Fit after COVID on severe post-infectious fatigue. Participants are eligible if they report severe fatigue 3 up to and including 12 months following COVID-19. One hundred and fourteen participants will be randomised to either Fit after COVID or care as usual (ratio 1:1). The primary outcome, the fatigue severity subscale of the Checklist Individual Strength (CIS-fatigue), is assessed in both groups before randomisation (T0), directly post CBT or following care as usual (T1), and at follow-up 6 months after the second assessment (T2). In addition, a long-term follow-up (T3), 12 months after the second assessment, is performed in the CBT group only. The primary objective is to investigate whether CBT will lead to a significantly lower mean fatigue severity score measured with the CIS-fatigue across the first two follow-up assessments (T1 and T2) as compared to care as usual. Secondary objectives are to determine the proportion of participants no longer being severely fatigued (operationalised in different ways) at T1 and T2 and to investigate changes in physical and social functioning, in the number and severity of somatic symptoms and in problems concentrating across T1 and T2. DISCUSSION: This is the first trial testing a cognitive behavioural intervention targeting severe fatigue after COVID-19. If Fit after COVID is effective in reducing fatigue severity following COVID-19, this intervention could contribute to alleviating the long-term health consequences of COVID-19 by relieving one of its most prevalent and distressing long-term symptoms. TRIAL REGISTRATION: Netherlands Trial Register NL8947 . Registered on 14 October 2020.

Shared Individual Formulation Therapy (SIFT): an open-label trial of a new therapy accommodating patient heterogeneity in functional neurological disorder.

BACKGROUND: Functional Neurological Disorder (FND) is a complex neuropsychiatric condition with a multifactorial aetiology. The heterogeneity of patients with FND is rarely considered in psychotherapy trials, which may contribute to variable outcomes. Shared Individual Formulation Therapy (SIFT) is a new, brief (four session) psychotherapy that aims to accommodate heterogeneity by providing a personalised, trans-theoretical formulation of the person's difficulties and accompanying management plan. METHODS: An open-label, prospective trial of outpatient SIFT for adults with FND was conducted, using health-related quality of life (SF-12) as the principal outcome measure, with secondary measures of mental health, dissociation, health care use and attitude to the FND diagnosis. Measures were collected at baseline, end of treatment and 6- and 12-month follow-ups. RESULTS: Twenty-nine participants with various FND symptoms enrolled. Twenty-four completed all four sessions and 25 completed follow-up measures at 12 months. SF-12 scores improved significantly at end of treatment and were sustained throughout follow-up with moderate effect sizes (0.39-0.47; all p < 0.001). Most secondary outcomes also improved significantly at all time points. The intervention was highly acceptable and tolerable to patients and perceived as beneficial. CONCLUSION: This trial provides preliminary evidence for initial and sustained benefit from SIFT for adults with FND. Further study is needed to validate these findings.

Freud's hysteria and its legacy.

Though Freud was himself interested in neurologic disorders, the model of hysteria he developed - of the repression of painful experiences, and their conversion into physical symptoms - made the disorder psychiatric, as the increasingly complex explanations came to rely on the "meaning" of events, which could not easily be understood neurologically. This evolved to become a prototype for psychiatric illness more broadly, a model which, though challenged by the First World War, enjoyed great success, notably in the USA, dominating psychiatric thinking for most of the 20th century. Concerns about the empiric basis for his ideas latterly led to a rapid decline in their importance, however, exemplified by 1980's "etiologically neutral" DSM-III. Hysteria, now renamed conversion disorder, retained its Freudian explanation for another 30 years, but as psychiatry lost its faith in Freud, so psychiatrists stopped seeing the disorder he had made theirs, and returned it once more to neurology.

Life events and escape in conversion disorder.

BACKGROUND: Psychological models of conversion disorder (CD) traditionally assume that psychosocial stressors are identifiable around symptom onset. In the face of limited supportive evidence such models are being challenged. METHOD: Forty-three motor CD patients, 28 depression patients and 28 healthy controls were assessed using the Life Events and Difficulties Schedule in the year before symptom onset. A novel 'escape' rating for events was developed to test the Freudian theory that physical symptoms of CD could provide escape from stressors, a form of 'secondary gain'. RESULTS: CD patients had significantly more severe life events and 'escape' events than controls. In the month before symptom onset at least one severe event was identified in 56% of CD patients - significantly more than 21% of depression patients [odds ratio (OR) 4.63, 95% confidence interval (CI) 1.56-13.70] and healthy controls (OR 5.81, 95% CI 1.86-18.2). In the same time period 53% of CD patients had at least one 'high escape' event - again significantly higher than 14% in depression patients (OR 6.90, 95% CI 2.05-23.6) and 0% in healthy controls. Previous sexual abuse was more commonly reported in CD than controls, and in one third of female patients was contextually relevant to life events at symptom onset. The majority (88%) of life events of potential aetiological relevance were not identified by routine clinical assessments. Nine per cent of CD patients had no identifiable severe life events. CONCLUSIONS: Evidence was found supporting the psychological model of CD, the Freudian notion of escape and the potential aetiological relevance of childhood traumas in some patients. Uncovering stressors of potential aetiological relevance requires thorough psychosocial evaluation.

A structural MRI study of motor conversion disorder: evidence of reduction in thalamic volume.

OBJECTIVE: To investigate potential abnormalities in subcortical brain structures in conversion disorder (CD) compared with controls using a region of interest (ROI) approach. METHODS: Fourteen patients with motor CD were compared with 31 healthy controls using high-resolution MRI scans with an ROI approach focusing on the basal ganglia, thalamus and amygdala. Brain volumes were measured using Freesurfer, a validated segmentation algorithm. RESULTS: Significantly smaller left thalamic volumes were found in patients compared with controls when corrected for intracranial volume. These reductions did not vary with handedness, laterality, duration or severity of symptoms. CONCLUSIONS: These differences may reflect a primary disease process in this area or be secondary effects of the disorder, for example, resulting from limb disuse. Larger, longitudinal structural imaging studies will be required to confirm the findings and explore whether they are primary or secondary to CD.