Study development and protocol for a cohort study examining the impact of baseline social cognition on response to treatment for people living with post-traumatic stress disorder.

Background: Social cognitive impairments, specifically in facial emotion processing and mental state attribution, are common in post-traumatic stress disorder. However few studies so far have examined whether social cognitive ability impacts on PTSD recovery. Objective: To examine whether baseline social cognitive abilities are associated with treatment outcomes following trauma-focused therapy for PTSD. Method: This is a cohort study that will relate treatment outcomes post-discharge to baseline measures of social cognition (five tasks: Emotion Odd-One-Out Task (Oddity), Reading the Mind in the Eyes Task (RMET), Social Shapes Test (SST), Spontaneous Theory of Mind Protocol (STOMP), and Reflective Functioning Questionnaire (RFQ-8)) in people starting a course of psychological therapy for PTSD (target N = 60). The primary outcome will be pre- to post-treatment change in PTSD symptom severity (assessed using the PTSD Checklist for DSM-5). Secondary outcomes include functional impairment (assessed using the Work and Social Adjustment Scale), drop-out rate, and analyses differentiating participants with DSM-5 PTSD and ICD-11 PTSD and CPTSD. Regression models will be used to examine associations between baseline social cognitive performance and outcome measures while adjusting for potential confounders. Two pilot studies informed the development of our study protocol. The first involved qualitative analysis of interviews with nine participants with lived experience of mental health problems to inform our research questions and study protocol. The second involved trialling social cognitive tasks on 20 non-clinical participants to refine our test battery. Discussion: This study will address a gap in the literature about whether abilities in social cognition in people living with PTSD are associated with treatment-related recovery. HIGHLIGHTS: Impairments in social cognition are recognised in people with PTSD.Few studies have examined whether social cognitive ability is associated with recovery from PTSD.We present a study protocol, developed after pilot testing, to address this question.

Antecedentes: Las deficiencias en la cognición social, específicamente en el procesamiento de las emociones faciales y de la atribución de estados mentales, son comunes en el trastorno de estrés postraumático (TEPT). Sin embargo, hasta el momento pocos estudios han evaluado si la habilidad cognitiva social tiene un impacto en la recuperación del TEPT.Objetivo: Evaluar si las habilidades de cognición social de base están asociadas con los resultados del tratamiento después de la terapia centrada en el trauma para el TEPT.Métodos: Este es un estudio de cohortes que relacionará los resultados posteriores al alta del tratamiento con las medidas de referencia de la cognición social mediante cinco pruebas: la tarea de la emoción no correspondiente ('Emotion Odd-One-Out Task (Oddity)'), la tarea de lectura de la mente a través de la mirada ('Reading the Mind in the Eyes Task (RMET)'), la prueba de las figuras sociales ('Social Shapes Test (SST)'), el protocolo para la teoría de la mente espontánea ('Spontaneous Theory of Mind Protocol (STOMP)'), y el cuestionario de funcionamiento reflexivo ('Reflective Functioning Questionnaire (RFQ-8)'. Estas pruebas fueron realizadas en personas al iniciar el transcurso de la terapia psicológica para el TEPT (N objetivo = 60). El resultado principal será el cambio en la severidad de los síntomas del TEPT antes y después del tratamiento (evaluado utilizando la lista de verificación de síntomas de TEPT del DSM-5). Los resultados secundarios incluyen al deterioro funcional (evaluado mediante el cuestionario de trabajo y ajuste social, 'Work and Social Adjustment Scale' en inglés), la tasa de abandono, así como los análisis que diferencien a los participantes con TEPT según el DSM-5, y diferencien el TEPT y el TEPT complejo (TEPT-C) según la CIE-11. Se utilizarán modelos de regresión para examinar las asociaciones entre el rendimiento cognitivo social de referencia y las medidas de resultado mientras se ajustan por posibles variables de confusión. Dos estudios piloto sustentaron el desarrollo del protocolo del estudio. El primero involucró un análisis cualitativo de las entrevistas realizadas a nueve participantes con experiencias de problemas de salud mental para sustentar nuestras preguntas de investigación y el protocolo de estudio. El segundo involucró evaluar las pruebas de cognición social en veinte participantes sin condiciones clínicas para refinar la batería de pruebas.Discusión: Este estudio busca estrechar la brecha en la literatura sobre si las habilidades en la cognición social en personas que viven con TEPT están asociadas con la recuperación vinculada al tratamiento.

Examining the relationship between early childhood temperament, trauma, and post-traumatic stress disorder.

A greater understanding of why some people are more at risk of developing PTSD is required. We examine the relationship between temperament traits in early childhood and subsequent trauma exposure and risk of PTSD. We used data on 2017 participants from the Avon Longitudinal Study of Parents and Children (ALSPAC). Temperament was measured using the Carey Infant Temperament Scale (average score from ages 6 and 24 months). This provided data on 9 individuals traits, and Easy, Medium, and Difficult temperament clusters. Trauma exposure was measured from 0 to 17 years, and PTSD at age 23 years using the PTSD Checklist for DSM-V (PCL-5). Regression models were used to estimate associations between temperament and both trauma and PTSD, and to examine mediation (of temperament to PTSD pathway) and interaction (temperament X trauma on PTSD) effects. 1178 (58.4%) individuals were exposed to a trauma in childhood and 112 (5.5%) had PTSD. Higher levels of Intensity were associated with a small increase in trauma exposure (ORadjusted 1.23, 95% CI 1.12, 1.34; p < 0.001) and PTSD (ORadjusted 1.27, 95% CI 1.05, 1.54; p = 0.012). Higher levels of Activity, Adaptability, Mood and Threshold temperament traits were also associated with trauma exposure. Medium (ORadjusted 1.49, 95% CI 1.21, 1.84; p < 0.001) and Difficult (ORadjusted 1.47, 95% CI 1.18, 1.84; p = 0.001) temperament clusters were associated with increased trauma exposure compared to an Easy cluster, but were not associated with PTSD. The relationship between trait Intensity and adult PTSD was partially mediated by childhood/adolescent trauma (Indirect ORadjusted 1.08, 95% CI 1.01, 1.16, p = 0.024, proportion mediated 26.2%). There was some evidence that trait Intensity modified the relationship between trauma and PTSD (ORadjusted 1.66, 95% CI 1.07, 2.55, p = 0.023). PTSD in early adulthood is more common in those with intense stimuli responsiveness in childhood. Temperament traits might be useful predictors of trauma exposure and mental health outcomes and offer potential targets for supportive interventions.

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder.

BACKGROUND: 3,4-methylenedioxymethamphetamine (MDMA) therapy has qualities that make it potentially well suited for patients with addictions, but this has never been explored in a research study. We present data from the Bristol Imperial MDMA in Alcoholism (BIMA) study. This is the first MDMA addiction study, an open-label safety and tolerability proof-of-concept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD). AIMS: This study aimed to assess if MDMA-assisted psychotherapy can be delivered safely and can be tolerated by patients with AUD post detoxification. Outcomes regarding drinking behaviour, quality of life and psychosocial functioning were evaluated. METHODS: Fourteen patients with AUD completed a community alcohol detoxification and received an eight-week course of recovery-based therapy. Participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Safety and tolerability were assessed alongside psychological and physiological outcome measures. Alcohol use behaviour, mental well-being and functioning data were collected for nine months after alcohol detoxification. RESULTS: MDMA treatment was well tolerated by all participants. No unexpected adverse events were observed. Psychosocial functioning improved across the cohort. Regarding alcohol use, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the 'Outcomes' study) by the same team with a similar population of people with AUD. CONCLUSIONS: This study provides preliminary support for the safety and tolerability of a novel intervention for AUD post detox. Further trials to examine better the therapeutic potential of this approach are now indicated.

Exploration of population and practice characteristics explaining differences between practices in the proportion of hospital admissions that are emergencies.

BACKGROUND: Emergency (unscheduled) and elective (scheduled) use of secondary care varies between practices. Past studies have described factors associated with the number of emergency admissions; however, high quality care of chronic conditions, which might include increased specialist referrals, could be followed by reduced unscheduled care. We sought to characterise practices according to the proportion of total hospital admissions that were emergency admissions, and identify predictors of this proportion. METHOD: The study included 229 general practices in Leicestershire, Northamptonshire and Rutland, England. Publicly available data were obtained on scheduled and unscheduled secondary care usage, and on practice and patient characteristics: age; gender; list size; observed prevalence, expected prevalence and the prevalence gap of coronary heart disease, hypertension and stroke; deprivation; headcount number of GPs per 1000 patients; total and clinical quality and outcomes framework (QOF) scores; ethnicity; proportion of patients seen within two days by a GP; proportion able to see their preferred GP. Using the proportion of admissions that were emergency admissions, seven categories of practices were created, and a regression analysis was undertaken to identify predictors of the proportion. RESULTS: In univariate analysis, practices with higher proportions of admissions that were emergencies tended to have fewer older patients, higher proportions of male patients, fewer white patients, greater levels of deprivation, smaller list sizes, lower recorded prevalence of coronary heart disease and stroke, a bigger gap between the expected and recorded levels of stroke, and lower proportions of total and clinical QOF points achieved. In the multivariate regression, higher deprivation, fewer white patients, more male patients, lower recorded prevalence of hypertension, more outpatient appointments, and smaller practice list size were associated with higher proportions of total admissions being emergencies. CONCLUSION: In monitoring use of secondary care services, the role of population characteristics in determining levels of use is important, but so too is the ability of practices to meet the demands for care that face them. The level of resources, and the way in which available resources are used, are likely to be key in determining whether a practice is able to meet the health care needs of its patients.