An online mindfulness intervention for medical students in South Africa: A randomised controlled trial.

Background: Prior to the COVID-19 pandemic, an association was observed between medical students' stress, possibly because of an intensive academic workload and clinical responsibilities, and mental ill health. The literature has shown the benefit of online mindfulness interventions for different mental health challenges. Unfortunately, there is a paucity of information on their benefit to medical students in South Africa. Aim: The aim of this study was to explore whether medical students attending an online mindfulness-based intervention (MBI) would show improved resilience and stress management compared with attendance at an online supportive counselling (SC) programme. Secondary to this was the viability of the intervention, for which an in-depth understanding of participants' experiences was sought. Setting: The study setting was online through https://zoom.us/. Methods: Forty-five participants were randomly allocated between two 6-week, teacher-facilitated groups. A repeated measures analysis of variance (ANOVA) of outcome, well-being, perceived stress and self-compassion scores conducted at three time points, as well as thematic analysis of participant feedback, contributed to quantitative and qualitative data. Results: Participants in both the groups showed significant improvement over time in measures of well-being, perceived stress and subjective stress management. Participants in the mindfulness group showed a statistically significant treatment effect in mindfulness at programme completion. A decrease in self-compassion over time was observed in both the groups. Conclusion: The results of this study indicate that in this South African medical student cohort, an online MBI and a SC programme are both feasible and show potential for reducing stress, increasing stress management and increasing resilience. Further study in this area is recommended.

Long-term follow-up of a randomised controlled trial of prolonged exposure therapy and supportive counselling for post-traumatic stress disorder in adolescents: a task-shifted intervention.

BACKGROUND: Empirical evidence on the longer-term effectiveness of evidence-based treatments for adolescents with post-traumatic stress disorder (PTSD) in low-resource settings is needed. The aim of the study was to evaluate the maintenance of treatment gains achieved in a comparative study of effectiveness of prolonged exposure therapy for adolescents (PE-A) and supportive counselling (SC) in adolescents with PTSD up to 24-months post-treatment. METHOD: Sixty-three adolescents (13-18 years) with PTSD were randomly assigned to receive either of the interventions comprising 7-14 sessions of treatment provided by trained and supervised non-specialist health workers (NSHWs). The primary outcome measure was PTSD symptom severity, as independently assessed on the Child PTSD Symptom Scale, at pretreatment, post-treatment, and at 3-, 6-, 12- and 24-months post-treatment follow-up (FU) evaluations. RESULTS: Participants in both the prolonged exposure and SC treatment groups attained a significant reduction in PTSD symptoms and maintained this reduction in PTSD symptoms at 12- and 24-month assessment. Participants receiving prolonged exposure experienced greater improvement on the PTSD symptom severity scale than those receiving SC at 12-months FU [difference in PE-A v. SC mean scores = 9.24, 95% CI (3.66-14.83), p < 0.001; g = 0.88] and at 24-months FU [difference in PE-A v. SC mean scores = 9.35, 95% CI (3.53-15.17), p = 0.002; g = 0.68]. CONCLUSIONS: Adolescents with PTSD continued to experience greater benefit from prolonged exposure treatment than SC provided by NSHWs in a community setting 12 and 24 months after completion of treatment.

Prolonged exposure therapy and supportive counselling for posttraumatic stress disorder in adolescents in a community-based sample, including experiences of stakeholders: study protocol for a comparative randomized controlled trial using task-shifting.

BACKGROUND: There is a dearth of empirical evidence on the effectiveness of pharmacological and non-pharmacological treatments for adolescents with posttraumatic stress disorder (PTSD) in developing countries. The primary aim of the study is to examine the effects of prolonged exposure therapy compared with supportive counseling for adolescents with PTSD delivered by nurses trained as counselors. METHODS/DESIGN: A single-blind randomized clinical trial comprising 90 adolescents with PTSD using a permuted block design will be utilized. Nurses previously naïve to prolonged exposure and supportive counselling will be trained to provide these treatments at the adolescents' high schools. Data collection will last from March 2014 to December 2017 and annually thereafter, dependent on the availability of funding. Participants will receive seven to fourteen 60 min sessions of prolonged exposure treatment (n = 45) or supportive counselling (n = 45). All assessments will be conducted before treatment, at mid-treatment, immediately after treatment completion, at 3-, 6-, and 12-month follow-up, and annually thereafter. It is hypothesized that PE-A will be superior to SC in reducing PTSD symptoms at post-treatment as measured by the CPSS-I administered by an independent evaluator. It is further hypothesized that PE-A treatment gains will be maintained at 3-, 6- and 12-month follow-ups and annually thereafter. DISCUSSION: While early indications are that PE-A is an effective treatment for PTSD in adolescents, this study will help determine the effectiveness of PE-A in a South African, community setting (school-based) when task-shifted to nurses, as compared to SC. TRIAL REGISTRATION: Pan African Clinical Trials Registry: PACTR201511001345372 , retrospectively registered 11 November 2015.

Prolonged exposure therapy and supportive counselling for post-traumatic stress disorder in adolescents: task-shifting randomised controlled trial.

BACKGROUND: Empirical evidence on the effectiveness of evidence-based treatments for adolescents with post-traumatic stress disorder (PTSD) in low-resource settings is needed.AimsTo evaluate the comparative effectiveness of prolonged exposure and supportive counselling in adolescents with PTSD. METHOD: Sixty-three adolescents (13-18 years) with PTSD were randomly assigned to receive either of the interventions comprising 7-14 sessions of treatment (trial registration in the Pan African Clinical Trials Registry: PACTR201511001345372). The primary outcome measure was PTSD symptom severity, as independently assessed on the Child PTSD Symptom Scale at pre-treatment, post-treatment, and at 3- and 6-month follow-up. RESULTS: Participants receiving prolonged exposure experienced greater improvement on the PTSD symptom severity scale than those receiving supportive counselling (between group differences at post-intervention, mean 12.49, 95% CI 6.82-18.17, P<0.001; d = 1.22). A similar effect size was maintained at 3-month (d = 0.85) and 6-month (d = 1.02) follow-up assessments. CONCLUSIONS: Adolescents with PTSD experienced greater benefit from prolonged exposure treatment when provided by non-specialist health workers (nurses) in a community setting.Declaration of interestNone.

A pilot and feasibility randomised controlled study of Prolonged Exposure Treatment and supportive counselling for post-traumatic stress disorder in adolescents: a third world, task-shifting, community-based sample.

BACKGROUND: There is a dearth of empirical evidence on the effectiveness of pharmacological and nonpharmacological treatments for adolescents with post-traumatic stress disorder (PTSD) in developing country settings. The primary aim of this study was to demonstrate that Prolonged Exposure Treatment for Adolescents (PE-A) and supportive counselling (SC) are implementable by nurses in a South African context. A secondary aim was to perform a preliminary analysis of the effectiveness of registered nurses delivering either PE-A or SC treatment to adolescents with PTSD. It is hypothesised that PE-A will be superior to SC in terms of improvements in PTSD symptoms and depression. METHOD: A pilot, single-blind, randomised clinical trial of 11 adolescents with PTSD. Nurses previously naïve to Prolonged Exposure (PE) Treatment and SC provided these treatments at the adolescents' high schools. Data collection lasted from March 2013 to October 2014. Participants received twelve 60-90-min sessions of PE (n = 6) or SC (n = 5). All outcomes were assessed before treatment, at mid-treatment, immediately after treatment completion and at 12-month follow-up. The primary outcome, PTSD symptom severity, was assessed with the Child PTSD Symptom Scale-Interview (CPSS-I) (range, 0-51; higher scores indicate greater severity). The secondary outcome, depression severity, was assessed with the Beck Depression Inventory (BDI) (range, 0-41; higher scores indicate greater severity). RESULTS: Data were analysed as intention to treat. During treatment, participants in both the PE-A and SC treatment arms experienced significant improvement on the CPSS-I as well as on the BDI. There was a significant difference between the PE-A and SC groups in maintaining PTSD and depression at the 12-month post-treatment assessment, with the participants in the PE-A group maintaining their gains both on PTSD and depression measures. CONCLUSION: The treatment was adequately implemented by the nurses and well-tolerated by the participants. Preliminary results suggest that the delivery of either intervention led to a significant improvement in PTSD and depression symptoms immediately post treatment. The important difference was that improvement gains in PTSD and depression in the PE-A group were maintained at 12-month follow-up. The results of this pilot and feasibility study are discussed. TRIAL REGISTRATION: Pan African Clinical Trials Registry: PACTR201511001345372 , registered on 11 November 2015.

Sample to sample carryover: a source of analytical laboratory error and its relevance to integrated clinical chemistry/immunoassay systems.

BACKGROUND: Integrated systems that combine clinical chemistry and immunoassay analyzers are used routinely. Sample to sample carryover is an inherent risk and can cause erroneously high patient test results for immunoassays. IVD manufacturers and laboratories must be aware of this phenomenon and guard against it. METHODS: We used a sample carryover protocol that directs the clinical chemistry module to process samples with very high immunoassay analyte concentrations followed by samples with very low concentrations for the same analyte. Low concentration samples were then tested by the immunoassay module to determine if the clinical chemistry module caused primary sample tube to primary sample tube carryover of the immunoassay analyte. RESULTS: Sample carryover was assessed on the Abbott ci8200 for HBsAg, AFP, beta-hCG, and PSA. Observed HBsAg carryover met the design specification of <0.1 ppm. Carryover for the other analytes was <0.1 ppm or below the assay limit of detection. CONCLUSIONS: IVD manufacturers must design integrated systems to minimize primary specimen tube carryover and avoid analytical laboratory error that can impact patient safety. Carryover testing is difficult for clinical laboratories to perform in order to verify system performance. Laboratories must consider the potential for specimen carryover and its impact on results whether moving primary sample tubes between separate analyzers or using an integrated system.