Who benefits from digital interventions for bipolar disorder? Stage of illness characteristics as predictors of changes in quality of life.

OBJECTIVES: This study explored the potential role of stage-related variables in intervention outcomes in bipolar disorder (BD). Specifically, we aimed to identify which subgroups of individuals were most likely to experience improved quality of life following digitally delivered psychosocial interventions for BD. METHODS: The study involved a secondary analysis of combined data from two randomised control trials (RCTs). Each trial assessed the effectiveness of digitally delivered interventions for improving quality of life, in late-stage (ORBIT RCT) or early-stage (BETTER RCT) BD. Three iterations of cluster analyses were performed, identifying subgroups of individuals based on (i) current phenomenology, (ii) course of illness and (iii) medication response. The resultant subgroups were compared with regard to changes in quality of life pre-post intervention, via repeated measures ANOVAs. RESULTS: In each cluster analysis, two clusters were found. The current phenomenology clusters reflected two impairment levels, 'moderate impairment' and 'low impairment'. The course of illness clusters reflected 'more chronicity' and 'less chronicity' and the medication response clusters reflected 'good medication response' and 'poor medication response'. Differences in changes in quality of life over time were observed between the two current phenomenology clusters and between the medication response clusters, while the course of illness subgroups did not respond differently. CONCLUSIONS: There are at least two distinct groups of treatment-seeking individuals with established BD, based on illness features with previously established links to different illness stages. Clusters within the current phenomenology and medication response domains demonstrated significantly different trajectories of QoL change over time in the context of our interventions, highlighting potential implications for treatment selection aligned with precision psychiatry.

A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder.

BACKGROUND: The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet for people with bipolar disorder (BD) who have symptoms of sleep disorders or circadian rhythm sleep-wake disruption. This work builds on the growing evidence that TRE has benefits for improving circadian rhythms. TRE and Mediterranean diet guidance will be offered remotely using self-help materials and an app, with coaching support. METHODS: This study is an international RCT to compare the effectiveness of TRE and the Mediterranean diet. Three hundred participants will be recruited primarily via social media. Main inclusion criteria are: receiving treatment for a diagnosis of BD I or II (confirmed via DIAMOND structured diagnostic interview), endorsement of sleep or circadian problems, self-reported eating window of ≥ 12 h, and no current mood episode, acute suicidality, eating disorder, psychosis, alcohol or substance use disorder, or other health conditions that would interfere with or limit the safety of following the dietary guidance. Participants will be asked to complete baseline daily food logging for two weeks and then will be randomly allocated to follow TRE or the Mediterranean diet for 8 weeks, during which time, they will continue to complete daily food logging. Intervention content will be delivered via an app. Symptom severity interviews will be conducted at baseline; mid-intervention (4 weeks after the intervention begins); end of intervention; and at 6, 9, and 15 months post-baseline by phone or videoconference. Self-rated symptom severity and quality of life data will be gathered at those timepoints, as well as at 16 weeks post baseline. To provide a more refined index of whether TRE successfully decreases emotional lability and improves sleep, participants will be asked to complete a sleep diary (core CSD) each morning and complete six mood assessments per day for eight days at baseline and again at mid-intervention. DISCUSSION: The planned research will provide novel and important information on whether TRE is more beneficial than the Mediterranean diet for reducing mood symptoms and improving quality of life in individuals with BD who also experience sleep or circadian problems. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT06188754.

Pain-sensorimotor interactions: New perspectives and a new model.

How pain and sensorimotor behavior interact has been the subject of research and debate for many decades. This article reviews theories bearing on pain-sensorimotor interactions and considers their strengths and limitations in the light of findings from experimental and clinical studies of pain-sensorimotor interactions in the spinal and craniofacial sensorimotor systems. A strength of recent theories is that they have incorporated concepts and features missing from earlier theories to account for the role of the sensory-discriminative, motivational-affective, and cognitive-evaluative dimensions of pain in pain-sensorimotor interactions. Findings acquired since the formulation of these recent theories indicate that additional features need to be considered to provide a more comprehensive conceptualization of pain-sensorimotor interactions. These features include biopsychosocial influences that range from biological factors such as genetics and epigenetics to psychological factors and social factors encompassing environmental and cultural influences. Also needing consideration is a mechanistic framework that includes other biological factors reflecting nociceptive processes and glioplastic and neuroplastic changes in sensorimotor and related brain and spinal cord circuits in acute or chronic pain conditions. The literature reviewed and the limitations of previous theories bearing on pain-sensorimotor interactions have led us to provide new perspectives on these interactions, and this has prompted our development of a new concept, the Theory of Pain-Sensorimotor Interactions (TOPSMI) that we suggest gives a more comprehensive framework to consider the interactions and their complexity. This theory states that pain is associated with plastic changes in the central nervous system (CNS) that lead to an activation pattern of motor units that contributes to the individual's adaptive sensorimotor behavior. This activation pattern takes account of the biological, psychological, and social influences on the musculoskeletal tissues involved in sensorimotor behavior and on the plastic changes and the experience of pain in that individual. The pattern is normally optimized in terms of biomechanical advantage and metabolic cost related to the features of the individual's musculoskeletal tissues and aims to minimize pain and any associated sensorimotor changes, and thereby maintain homeostasis. However, adverse biopsychosocial factors and their interactions may result in plastic CNS changes leading to less optimal, even maladaptive, sensorimotor changes producing motor unit activation patterns associated with the development of further pain. This more comprehensive theory points towards customized treatment strategies, in line with the management approaches to pain proposed in the biopsychosocial model of pain.

Protocol for a randomised controlled trial of ketamine versus ketamine and behavioural activation therapy for adults with treatment-resistant depression in the community.

INTRODUCTION: Although short-term benefits follow parenteral ketamine for treatment-resistant major depressive disorder (TR-MDD), there are challenges that prevent routine use of ketamine by clinicians. These include acute dissociative effects of parenteral ketamine, high relapse rates following ketamine dosing and the uncertain role of psychotherapy. This randomised controlled trial (RCT) seeks to establish the feasibility of evaluating repeated oral doses of ketamine and behavioural activation therapy (BAT), compared with ketamine treatment alone, for TR-MDD. We also aim to compare relapse rates between treatment arms to determine the effect size of adding BAT to oral ketamine. METHODS AND ANALYSIS: This is a prospectively registered, two-centre, single-blind RCT. We aim to recruit 60 participants with TR-MDD aged between 18 and 65 years. Participants will be randomised to 8 weeks of oral ketamine and BAT, or 8 weeks of oral ketamine alone. Feasibility will be assessed by tracking attendance for ketamine and BAT, acceptability of treatment measures and retention to the study follow-up protocol. The primary efficacy outcome measure is the Montgomery-Asberg Depression Rating Scale (MADRS) measured weekly during treatment and fortnightly during 12 weeks of follow-up. Other outcome measures will assess the tolerability of ketamine and BAT, cognition and activity (using actigraphy). Participants will be categorised as non-responders, responders, remitters and relapsed during follow-up. MADRS scores will be analysed using a linear mixed model. For a definitive follow-up RCT study to be recommended, the recruitment expectations will be met and efficacy outcomes consistent with a >20% reduction in relapse rates favouring the BAT and ketamine arm will be achieved. ETHICS AND DISSEMINATION: Ethics approval was granted by the New Zealand Central Health and Disability Ethics Committee (reference: 2023 FULL18176). Study findings will be reported to participants, stakeholder groups, conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: UTN: U1111-1294-9310, ACTRN12623000817640p.

Emotion regulation and Residual Depression Predict Psychosocial Functioning in Bipolar Disorder: Preliminary Study / Regulación de las emociones y la depresión residual predicen el funcionamiento psicosocial en el trastorno bipolar: estudio preliminar

This study explores the predictive value of various clinical, neuropsychological, functional, and emotion regulation processes for recovery in Bipolar Disorder. Clinical and demographic information was collected for 27 euthymic or residually depressed BD participants. Seventy one percent of the sample reported some degree of impairment in psychosocial functioning. Both residual depression and problems with emotion regulation were identified as significant predictors of poor psychosocial functioning. In addition, to residual depression, the results of the current study introduce a variable of emotion dysregulation to account for poor psychosocial functioning among BD populations. Improving emotion regulation strategies, in particular, concentration and task accomplishment during negative emotional states could have important consequences for improving overall psychosocial functioning among this population, helping to reduce both the economic burden and high costs to personal wellbeing associated with BD.

Este estudio explora el valor predictivo de los diversos procesos de regulación clínicos, neuropsicológicos, funcionales y emocionales para la recuperación en el Trastorno Bipolar. La información clínica y demográfica se recogió de 27 participantes de TB eutímicos o residualmente deprimidos. Setenta y uno por ciento de la muestra reportó algún grado de deterioro en el funcionamiento psicosocial. Tanto la depresión residual y problemas con la regulación de las emociones fueron identificados como predictores significativos de mal funcionamiento psicosocial. Además de la depresión residual, los resultados del presente estudio introducen una variable de disregulación emocional para dar cuenta del pobre funcionamiento psicosocial en las poblaciones de TB. La mejora de las estrategias de regulación emocional, en particular, la concentración y la realización de tareas durante los estados emocionales negativos podrían tener consecuencias importantes para mejorar el funcionamiento psicosocial global en esta población ayudando a reducir tanto la carga económica y los altos costos para el bienestar personal asociado con TB.