Group problem management plus (PM+) to decrease psychological distress among Syrian refugees in Turkey: a pilot randomised controlled trial

Background Syrian refugees resettled in Turkey show a high prevalence of symptoms of mental disorders. Problem Management Plus (PM+) is an effective psychological intervention delivered by non-specialist health care providers which has shown to decrease psychological distress among people exposed to adversity. In this single-blind pilot randomised controlled trial, we examined the methodological trial procedures of Group PM+ (gPM+) among Syrian refugees with psychological distress in Istanbul, Turkey, and assessed feasibility, acceptability, perceived impact and the potential cost-effectiveness of the intervention. Methods Refugees with psychological distress (Kessler Psychological Distress Scale, K10 > 15) and impaired psychosocial functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16) were recruited from the community and randomised to either gPM+ and enhanced care as usual (E-CAU) (n = 24) or E-CAU only (n = 22). gPM+ comprised of five weekly group sessions with eight to ten participants per group. Acceptability and feasibility of the intervention were assessed through semi-structured interviews. The primary outcome at 3-month follow-up was symptoms of depression and anxiety (Hopkins Symptoms Checklist-25). Psychosocial functioning (WHODAS 2.0), symptoms of posttraumatic stress disorder and self-identified problems (Psychological Outcomes Profiles, PSYCHLOPS) were included as secondary outcomes. A modified version of the Client Service Receipt Inventory was used to document changes in the costs of health service utilisation as well as productivity losses. Results There were no barriers experienced in recruiting study participants and in randomising them into the respective study arms. Retention in gPM+ was high (75%). Qualitative analyses of the interviews with the participants showed that Syrian refugees had a positive view on the content, implementation and format of gPM+. No adverse events were reported during the implementation. The study was not powered to detect an effect. No significant difference between gPM+ and E-CAU group on primary and secondary outcome measures, or in economic impacts were found. Conclusions gPM+ delivered by non-specialist peer providers seemed to be an acceptable, feasible and safe intervention for Syrian refugees in Turkey with elevated levels of psychological distress. This pilot RCT sets the stage for a fully powered RCT. Trial registration ClinicalTrials.gov Identifier NCT03567083; date: 25/06/2018.

Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial

Background Prior studies have established that senses of the limb position in space (proprioception and kinaesthesia) are important for motor control and learning. Although nearly one-half of stroke patients have impairment in the ability to sense their movements, somatosensory retraining focusing on proprioception and kinaesthesia is often overlooked. Interventions that simultaneously target motor and somatosensory components are thought to be useful for relearning somatosensory functions while increasing mobility of the affected limb. For over a decade, robotic technology has been incorporated in stroke rehabilitation for more controlled therapy intensity, duration, and frequency. This pilot randomised controlled trial introduces a compact robotic-based upper-limb reaching task that retrains proprioception and kinaesthesia concurrently. Methods Thirty first-ever chronic stroke survivors (> 6-month post-stroke) will be randomly assigned to either a treatment or a control group. Over a 5-week period, the treatment group will receive 15 training sessions for about an hour per session. Robot-generated haptic guidance will be provided along the movement path as somatosensory cues while moving. Audio-visual feedback will appear following every successful movement as a reward. For the same duration, the control group will complete similar robotic training but without the vision occluded and robot-generated cues. Baseline, post-day 1, and post-day 30 assessments will be performed, where the last two sessions will be conducted after the last training session. Robotic-based performance indices and clinical assessments of upper limb functions after stroke will be used to acquire primary and secondary outcome measures respectively. This work will provide insights into the feasibility of such robot-assisted training clinically. Discussion The current work presents a study protocol to retrain upper-limb somatosensory and motor functions using robot-based rehabilitation for community-dwelling stroke survivors. The training promotes active use of the affected arm while at the same time enhances somatosensory input through augmented feedback. The outcomes of this study will provide preliminary data and help inform the clinicians on the feasibility and practicality of the proposed exercise. Trial registration ClinicalTrials.gov NCT04490655. Registered 29 July 2020.

Feasibility and safety of an immersive virtual reality-based vestibular rehabilitation programme in people with multiple sclerosis experiencing vestibular impairment: a protocol for a pilot randomised controlled trial

IntroductionVestibular system damage in patients with multiple sclerosis (MS) may have a central and/or peripheral origin. Subsequent vestibular impairments may contribute to dizziness, balance disorders and fatigue in this population. Vestibular rehabilitation targeting vestibular impairments may improve these symptoms. Furthermore, as a successful tool in neurological rehabilitation, immersive virtual reality (VRi) could also be implemented within a vestibular rehabilitation intervention.Methods and analysisThis protocol describes a parallel-arm, pilot randomised controlled trial, with blinded assessments, in 30 patients with MS with vestibular impairment (Dizziness Handicap Inventory ≥16). The experimental group will receive a VRi vestibular rehabilitation intervention based on the conventional Cawthorne-Cooksey protocol; the control group will perform the conventional protocol. The duration of the intervention in both groups will be 7 weeks (20 sessions, 3 sessions/week). The primary outcomes are the feasibility and safety of the vestibular VRi intervention in patients with MS. Secondary outcome measures are dizziness symptoms, balance performance, fatigue and quality of life. Quantitative assessment will be carried out at baseline (T0), immediately after intervention (T1), and after a follow-up period of 3 and 6 months (T2 and T3). Additionally, in order to further examine the feasibility of the intervention, a qualitative assessment will be performed at T1.Ethics and disseminationThe study was approved by the Andalusian Review Board and Ethics Committee, Virgen Macarena-Virgen del Rocio Hospitals (ID 2148-N-19, 25 March 2020). Informed consent will be collected from participants who wish to participate in the research. The results of this research will be disseminated by publication in peer-reviewed scientific journals.Trial registration numberNCT04497025.