ABSTRACT
It is increasingly recognised that many people with intellectual disabilities suffer from post-traumatic stress disorder (PTSD). Eye-movement desensitisation and reprocessing (EMDR) has been proposed as a potentially helpful intervention that is less reliant on verbal skills than other effective treatments for PTSD and therefore could be more effective than verbal interventions for people with intellectual disabilities. The Trauma-AID project is a randomised clinical trial (RCT) evaluating the effectiveness of a bespoke EMDR protocol for adults with intellectual disability and PTSD, which incorporates a prolonged phase of Psycho-Education and Stabilisation (PES) prior to the trauma confrontation phase of EMDR. The COVID-19 pandemic struck during the feasibility phase of the Trauma-AID project, necessitating a second feasibility study to evaluate the acceptability and feasibility of remote or hybrid delivery of the PES + EMDR protocol. To this end, we conducted two online surveys of therapists followed by interviews with clients, carers and senior therapists. The surveys were analysed descriptively. Content analysis was used for client and carer interviews, and framework analysis for therapist interviews. All stakeholders reported positive experiences of EMDR;however, some challenges were identified. The majority of clients, carers and therapists interviewed reported that the intervention, whether PES alone or the full PES-EMDR package, had improved symptoms of PTSD and psychological well-being, and carers also reported decreases in challenging behaviour. A full account of the data is provided in four Supplementary Digital files. PES-EMDR therapy appears both feasible and acceptable for clients with intellectual disabilities and therapists, whether delivered face-to-face or in a remote or hybrid mode, though remote working appears easier for the PES phase than the EMDR phase of the intervention. © 2023 The Authors. Journal of Policy and Practice in Intellectual Disabilities published by International Association for the Scientific Study of Intellectual and Developmental Disabilities and Wiley Periodicals LLC.
ABSTRACT
Introduction At present, vaccines form the only mode of prophylaxis against COVID-19. The time needed to achieve mass global vaccination and the emergence of new variants warrants continued research into other COVID-19 prevention strategies. The severity of COVID-19 infection is thought to be associated with the initial viral load, and for infection to occur, viruses including SARS-CoV-2 must first penetrate the respiratory mucus and attach to the host cell surface receptors. Carrageenan, a sulphated polysaccharide extracted from red edible seaweed, has shown efficacy against a wide range of viruses in clinical trials through the prevention of viral entry into respiratory host cells. Carrageenan has also demonstrated in vitro activity against SARS-CoV-2. Methods and analysis A single-centre, randomised, double-blinded, placebo-controlled phase III trial was designed. Participants randomised in a 1:1 allocation to either the treatment arm, verum Coldamaris plus (1.2 mg iota-carrageenan (Carragelose®), 0.4 mg kappa-carrageenan, 0.5% sodium chloride and purified water), or placebo arm, Coldamaris sine (0.5% sodium chloride) spray applied daily to their nose and throat for 8 weeks, while completing a daily symptom tracker questionnaire for a total of 10 weeks. Primary outcome Acquisition of COVID-19 infection as confirmed by a positive PCR swab taken at symptom onset or seroconversion during the study. Secondary outcomes include symptom type, severity and duration, subsequent familial/household COVID-19 infection and infection with non-COVID-19 upper respiratory tract infections. A within-trial economic evaluation will be undertaken, with effects expressed as quality-adjusted life years. Discussion This is a single-centre, phase III, double-blind, randomised placebo-controlled clinical trial to assess whether carrageenan nasal and throat spray reduces the risk of development and severity of COVID-19. If proven effective, the self-administered prophylactic spray would have wider utility for key workers and the general population. Trial registration NCT04590365;ClinicalTrials.gov NCT04590365. Registered on 19 October 2020. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-022-06685-z.