Sleep-related attentional bias in insomnia: The mediating role of arousal.

BACKGROUND AND OBJECTIVES: Characterize the nature of attentional biases toward nocturnal and diurnal sleep-related stimuli in individuals with insomnia disorder. We investigated the contributing role of sleep-related attentional biases in insomnia severity and whether their effects on insomnia severity were mediated by arousal and valence levels of the presented stimuli. METHODS: Sixty-four individuals with insomnia disorder and 70 controls completed two Posner spatial cueing tasks including both nocturnal (alarm clocks) and diurnal (fatigue) pictorial stimuli associated with neutral cues. Arousal and valence of the sleep-related stimuli were assessed using a 5-point Likert type scale. RESULTS: Attention biases characterized by difficulty disengaging from and increased avoidance for daytime fatigue, and by difficulty disengaging from alarm clocks were observed in individuals with insomnia disorder compared to controls. On the whole sample, difficulty to disengage from diurnal and nocturnal sleep-related stimuli were related mostly to higher arousal rating of sleep-related stimuli and insomnia severity. Higher arousal rating for sleep-related stimuli mediates the relationship between difficulty disengaging and insomnia severity. LIMITATIONS: The cross-sectional nature of the study. CONCLUSIONS: We provide first initial evidence for an attentional bias characterized by on one side, avoidance for diurnal sleep-related stimuli and on other side, disengagement for both diurnal and nocturnal sleep-related stimuli in patients with insomnia. Disengagement difficulties for both diurnal and nocturnal sleep-related stimuli indirectly affected insomnia severity through arousal elicited by these stimuli. It appears important to develop and apply attentional bias modification training therapeutic interventions that can effectively reduce sleep-related arousal and attentional biases.

Are thoughts and behaviours of individuals with schizophrenia more susceptible to being influenced during pandemic situations? A glimpse provided by the COVID-19 pandemic.

Individuals with psychotic disorders such as schizophrenia may be more vulnerable during pandemics, but research on this topic is limited. This study examined COVID-19 impact on a population affected by schizophrenia during the COVID-19 pandemic. Levels of psychological distress and COVID-19-related behaviours, from the COVID-related Thoughts and Behavioral Symptoms (Cov-Tabs) Scale, were compared between 107 patients with schizophrenia and 70 control participants. Participants with schizophrenia had significantly higher Cov-Tabs scores than non-clinical participants. These results suggest a higher vulnerability in this population, emphasising the need for targeted support and further assessment.

Cross-sectional study on the dissociation of decision-making capacity for antipsychotic treatment and COVID-19 vaccination in individuals with schizophrenia.

Objective: Decision-making capacity for treatment is impaired in schizophrenia but it remains unknown if schizophrenia affects distinct decision-making capacities differently. Methods: In this study, we assessed concomitantly two decision-making capacities (i.e., antipsychotic treatment and COVID-19 vaccination) in 27 schizophrenia patients. Sociodemographic variables, psychotic symptoms, global cognition and insight were also assessed. Results: We found that among individuals incompetent to consent to antipsychotic treatment, one-third had preserved capacity to consent to vaccination. No significant associations between the two different decision-making capacities were found. Psychotic symptoms and cognition were associated with the capacity to consent to antipsychotic treatment and to vaccination, respectively. Conclusion: Clinicians should be aware that capacity to consent to treatment is not unidimensional and vary across domains in individuals with schizophrenia. Being incompetent regarding one treatment does not mean to be incompetent for another treatment in this clinical population.

French adult normative data for a Standard Executive Neuropsychological Test Battery.

OBJECTIVE: Executive impairments are frequent and may concern a large spectrum of health conditions throughout life. Given the complexity of the executive functions, their assessment requires the administration of multiple tests. There is only one source of French-language normative data for seven traditional executive tests for adults under age 50. The aim of the present study was to establish demographically adjusted normative data of four executive tests commonly used during the neuropsychological assessment in France for adults aged 18-65. METHOD: The following tools were administered to 518 community adults aged from 18 to 65: Digit Span, Trail Making Test, Color Word Interference Test, and Verbal Fluency Test. An Overall Test Battery Mean was computed. Multiple regressions were computed for normally distributed scores and percentiles were established for non-normally distributed scores. RESULTS: Multiple regression analyses indicated that younger age and higher education were both associated with better performance. Age did not predict the number of correct responses on the Verbal Fluency Test. Gender did not have any effect on executive performances. Regression equations to calculate Z-scores are presented. Percentiles are presented for the number of recorded errors on the Trail Making Test, Color Word Interference Test, and Verbal Fluency Test. CONCLUSIONS: We provide reliable and updated norms for four executive tests that are among the most used by clinical neuropsychologists in France. Our work represents a valuable addition to the limited norms currently available for the assessment of executive functions in French young and middle-aged adults.

[Montessori Method applied to dementia, a person-centered global approach Part 2. Review of literature, effects and perspectives]. / La méthode Montessori adaptée aux personnes âgées présentant des troubles cognitifs, une approche globale centrée sur la personne Partie 2. Données de la littérature scientifique, effets et perspectives.

During the last ten years, the Montessori method has become a popular approach for the care of older adults living with dementia, with a growing number of institutions claiming its use. In this context, this narrative review aims at summarizing the research on its effects, benefits, and potential limits. Since the end of the 90s, a growing number of researchers across the world have investigated the Montessori method applied to dementia. Most of those studied the effects of Montessori activities. A few putted their focus on Montessori as a global, person-centered model of care. In general, research shows significant positive effects of Montessori on engagement, behaviors, affects, and functional abilities, as, for example, eating abilities. Benefits for caregivers have also been demonstrated. However, an important part of this research suffers from methodological weaknesses. In the future, other research is necessary to better understand the effects and best application conditions of Montessori method, especially in French speaking countries. Qualitative studies also seem to be a promising path to better understand where this new model of care can best lead those who apply it.

Imagining one's personal future in women undergoing treatment for breast cancer: an exploratory study.

We assessed self-defining future projections (SDFPs) in women with breast cancer (BC) and their relationships with disease characteristics and quality of life. Forty women with BC in the course of treatment and 50 controls were asked to generate SDFPs and completed questionnaires for depression and anxiety symptoms and quality of life. There was no group difference regarding specificity, meaning making, probability of produced future events, and the experience of a sense of personal continuity within SDFPs. BC patients' SDFPs were less distant in the future and characterised by more narratives about life threatening events and fewer narratives about future achievements. Chemotherapy was related to narratives about life threatening events and BC. Patients undergoing breast reconstruction reported fewer life-threatening events related to their cancer. Lower quality of life was associated with lower narratives about relationships in patients. Women undergoing treatment for BC envision their future in a less optimistic way with more narratives about life threatening events and a reduced time perspective that varied according to the type of treatment. Self-continuity and ability to imagine future specific events were preserved in patients, which are important processes helping individuals to cope with life difficulties and find meaning and direction in life.

"Green et al. Paranoid Thoughts Scale-revised": Structural invariance and clinical utility of a brief version in schizophrenia.

OBJECTIVE: Persecutory ideas are highly frequent in psychotic disorders and particularly in schizophrenia. Although several measures exist to assess persecutory ideas in both clinical and non-clinical samples, there is a need for brief and psychometrically sound measures to capture the multidimensional aspects of paranoia in people diagnosed with schizophrenia. Our aim was to validate a brief version of the revised Green et al., Paranoid Thoughts Scale (R-GPTS) in schizophrenia in order to minimize time-consuming assessment. METHODS: 100 individuals with schizophrenia and 72 non-clinical controls were recruited. We used the GPTS-8, a brief 8-item version of the R-GPTS recently developed and validated in the French general population. Psychometric properties of the scale were investigated including its factor structure, internal consistency, and convergent/divergent validities. RESULTS: Confirmatory factor analysis supported the original two-factor structure (social reference and persecution subscales) of the GPTS-8. The GPTS-8 was positively and moderately correlated with the Positive and Negative Syndrome Scale (PANSS) suspiciousness item indicating good internal consistency. Concerning divergent validity, no correlations were found between the GPTS-8 and the Montreal cognitive assessment (MoCA). Importantly patients with schizophrenia reported higher scores on the GTPS-8 than controls demonstrating its clinical validity. CONCLUSIONS: The French GPTS 8-item brief scale-8 retains the psychometric strengths of the R-GPTS in schizophrenia with relevant clinical validity. The GPTS-8 can consequently be used as a short and quick measure of paranoid ideations in individuals with a diagnosis of schizophrenia.

[Montessori Method applied to dementia, a person-centered global approach Part 1: Origins and principles]. / La méthode Montessori adaptée aux personnes âgées présentant des troubles cognitifs, une approche globale centrée sur la personne Partie 1 : Origines et grands principes fondamentaux.

While dementia care is going through a major crisis, a strong call for the development of person-centered care for persons with a diagnosis of dementia has recently emerged. Person-centered care (PCC) is a philosophical and theorical intervention framework acknowledging that the individual is still a person who can live positive life experiences and relationships, despite a progressive disease, even at severe stages. It has arisen as a response to a medical model, focused on pathology and deficits. The benefits of PCC have been well documented. However, questions remain about how to concretely provide it. In this context, the Montessori method applied to dementia represents one way to apply person-centered care to person with dementia. Based on the philosophy and principles of the scientific pedagogy developed by Maria Montessori, it integrates PCC principles, associated with rehabilitation techniques, to promote constructive engagement in meaningful activities, to give back sense of control to the person with dementia, and to allow the person to have a role in the community. In this article, we will first present the person-centered care philosophy, its main principles, and effects. Secondly, we will describe a brief historical perspective of the Montessori method for person with dementia. Then, we will present Montessori principles in a detailed and structured way.

Preliminary evidence that fatigue contributes to anhedonia in stable individuals diagnosed with schizophrenia.

Objectives: Anhedonia and fatigue are trans-diagnostic symptoms commonly observed in schizophrenia. Anhedonia is a core negative symptom with a strong relationship with depression and is associated with diminished global functioning. Similarly, fatigue is also associated to depression and research across psychiatric illnesses indicate that fatigue may persist even when primary symptoms are treated. Although fatigue is common in people diagnosed with schizophrenia, it is under studied within this population. The objective of this exploratory study was to investigate the association of fatigue and anhedonia by controlling for depression in a sample of individuals diagnosed with schizophrenia. Method: Fifty-one stable individuals diagnosed with schizophrenia from the University Department of Adult Psychiatry in Montpellier took part in this study. Participants completed questionnaires on fatigue impact and depression, and were assessed for symptom severity. Following data collection, statistical analyses were conducted in order to explore associations between clinical variables and fatigue impact. Based on the results obtained, a hierarchical linear regression was conducted in order to investigate whether fatigue impact contributed to the variance of negative symptoms. Results: The hierarchical linear regression indicated that when controlling for depression, fatigue impact contributes to ~20% of the variance of anhedonia. Together the social impact of fatigue and depression contribute to 24% of the variation of anhedonia. Conclusion: To the best of our knowledge, this exploratory study is the first to investigate and show that fatigue impact may contribute to anhedonia. We recommend further research to investigate fatigue, its impact on symptomatology, and better categorization of negative symptoms in hopes of developing targeted fatigue treatment interventions.

Diminished capacity to make treatment decision for COVID-19 vaccination in schizophrenia.

Recent evidence suggests that people with schizophrenia are at high risk for severe COVID-19 and should be prioritized for vaccination. However, impaired decision-making capacities could negatively affect the uptake of COVID-19 vaccination in this population. Capacity to consent to COVID-19 vaccination was assessed in 80 outpatients with schizophrenia. Using the MacArthur Competence Assessment Tool for Treatment, 56.3% of the sample were classified as having diminished capacity to consent to the vaccination. Diminished capacity to consent to COVID-19 vaccination was associated with lower vaccination rates, poorer cognition and higher level of psychotic symptoms. Developing interventions for enhancing informed consent for vaccination is urgent within this population.

Attitudes towards Vaccines, Intent to Vaccinate and the Relationship with COVID-19 Vaccination Rates in Individuals with Schizophrenia.

Schizophrenia patients are at high risk of developing severe COVID-19 outcomes but recent evidence suggests that they are under-vaccinated. This study explored the role of potential attitudinal barriers by comparing schizophrenia patients with participants from the general population regarding COVID-19 vaccination rates, general attitudes towards vaccines, and willingness to take a COVID-19 vaccine. We conducted a cross-sectional study between April 2021 and October 2021. A total of 100 people with schizophrenia and 72 nonclinical controls were recruited. In our study, individuals with schizophrenia were under-vaccinated, despite similar general attitudes towards vaccination and higher willingness to be vaccinated against COVID-19 compared to nonclinical participants. In patients, negative attitudes toward vaccines were related to higher levels of negative psychotic symptoms and higher levels of paranoid ideation. As a whole, participants with more negative attitudes towards vaccines were less likely to be vaccinated against COVID-19 and had lower levels of trust in institutions. Vaccine hesitancy does not appear to be a major barrier for COVID-19 vaccine uptake amongst people with schizophrenia. This study suggests that disparities in COVID-19 vaccination rates in schizophrenia do not seem related to attitudinal but rather structural barriers.

The influence of Alzheimer's disease stigma on pain assessment in older persons.

INTRODUCTION: Pain of nursing homes residents with Alzheimer's disease remains under detected compared to their cognitively intact counterparts. Communication difficulties may partly explain this poor quality of care but the influence of stigmatization on pain assessment has never been explored. RESEARCH QUESTION: The objective of this research was to analyze whether a diagnosis label of Alzheimer's disease or the stage of the disease may bias pain assessment scores and empathic reactions of health care staff in nursing homes. METHODS: Two studies were conducted based on a similar experimental between-subjects design with a video showing an older adult woman experiencing undefined pain. Different labels and vignettes were manipulated to characterize the subject of the video. In the first study, 84 certified nursing assistants were asked to watch the video and then to assess the pain intensity and their empathic reaction. Participants were randomized in two conditions that varied the disease label (Alzheimer's disease vs no diagnosis). In the second study, 67 certified nursing assistants were enrolled who did not participate in the first study. They watched the same video as in the first study and assessed the pain intensity and their empathic reaction. They were randomized in two conditions that varied the stage of the Alzheimer's disease (mild stage vs severe stage). RESULTS: Alzheimer's disease label had no influence on assessment scores. In contrast, the stage of the disease had a significant effect on the health care staff assessments with severe stage associated with lower pain intensity scores and empathic reactions. CONCLUSION: These results confirm that the Alzheimer's disease stigma is a real phenomenon that tends to be mainly elicited by the symptoms of the acute phase of the disease. These findings are crucial to better understand the stigma related to Alzheimer's disease and to enhance the pain management of this frail population.

Attention-Deficit/Hyperactivity Disorder, Insomnia, and Sleepiness Symptoms among a Community Adult Sample: The Mediating Effect of Executive Behavioral Regulation and Metacognition Abilities.

OBJECTIVE: Adult attention-deficit/hyperactivity disorder (ADHD) is characterized by a dysexecutive syndrome reflected in cognitive, emotional, and behavioral areas. Independently of a formal diagnosis of ADHD, higher ADHD symptoms are associated with higher levels of insomnia and sleepiness symptoms in adult population-based samples. Insomnia and sleepiness are sleep disorders that are both associated with deficits in several aspects of executive functions which in turn are likely to mimic a range of ADHD symptoms. Our objective was to explore the interrelationships between ADHD, insomnia, and sleepiness symptoms and executive functioning in community-dwelling adults. METHOD: A total of 442 participants (18-89 years, 56% females) underwent a semistructured clinical interview and completed questionnaires for insomnia, sleepiness, and everyday behaviors in which executive functions are implicated. Mediation Models were applied. RESULTS: Insomnia and sleepiness symptoms did not play a mediating role between ADHD symptoms and executive functioning. Conversely, our results highlighted a mediating effect of daytime insomnia consequences and sleepiness on ADHD symptoms via behavioral regulation executive symptoms (respectively, ß = -0.32, p < .001, 95% CI [-0.46, -0.20]; ß = 0.09, p < .05, 95% CI [0.02, 0.16]) and metacognitive executive symptoms (respectively, ß = -0.30, p < .001, 95% CI [-0.44, -0.18]; ß = 0.12, p < .01, 95% CI [0.04, 0.22]). CONCLUSIONS: Daytime insomnia consequences and sleepiness symptoms could lead to ADHD-like symptoms through their associated executive symptoms expressed in daily life. When faced with symptoms suggestive of ADHD in adults, insomnia and sleepiness should be systematically screened with standardized instruments.

Don't Bother Trying, They Won't Do It! Effect of Responsive Behaviors on the Montessori Assessment System.

OBJECTIVES: The Montessori Assessment System (MAS) is an assessment tool that aims at assessing preserved abilities in persons with moderate to severe dementia and to serve as basis for person-centered interventions. As responsive behaviors are highly frequent in this population, we assessed their possible influence on the MAS administration and results. METHODS: 193 persons with a diagnosis of dementia in the moderate to severe stages living in nursing homes completed the MAS. Responsive behaviors were assessed by the Neuropsychiatric Inventory (NPI). RESULTS: The NPI scores were heterogeneous, but responsive behaviors were present for at least 5 NPI domains in more than 50% of the participants. While NPI scores had weak relationships with MAS completion time and total score, primarily for the hallucinations, euphoria, and aberrant motor behaviors domains, a large majority of the participants fully completed the MAS. CONCLUSIONS: The presence of responsive behaviors as assessed by the NPI does not limit MAS administration, despite minor influence on MAS score and completion time. CLINICAL IMPLICATIONS: The MAS may be applied to persons with moderate to severe dementia presenting responsive behaviors. Assessment of preserved abilities can greatly improve the design of person-centered care plans in this population.

Apathy and executive functioning among non-demented community-dwelling elderly individuals in an everyday environment: the mediating effect of impulsivity.

BACKGROUND: Apathy is common in normal ageing and widely recognized as a predictor of cognitive decline, especially in executive functions. Much less characterized than apathy in the elderly is impulsivity, which increases with ageing. It is also frequently described in comorbidity with apathy in various clinical populations, in whom it is associated with poorer executive functioning. In the present study, by capitalizing on a multidimensional approach, we explore the mediating role of facets of impulsivity on the bidirectional relationships between apathy dimensions and executive functioning in non-demented community-dwelling elderly individuals in daily life. METHODS: A sample of non-demented community-dwelling older adults (n = 101) completed self-rated questionnaires. Apathy was measured by the Apathy Evaluation Scale; impulsivity was examined through the Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency (UPPS-P) Impulsive Behaviour Scale; and executive functioning in daily life was assessed by the Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A). Two models positing mediation were tested using conditional process modelling. RESULTS: Hierarchical regressions controlling for depressive symptoms indicated that the cognitive apathy dimension was associated with the UPPS-P facets sensation seeking, lack of perseverance, and premeditation. Among the UPPS-P facets, lack of perseverance and negative urgency were found to contribute significantly to BRIEF-A Metacognitive index variance. Finally, in both models, lack of perseverance was found to totally mediate the relationship between cognitive apathy and the BRIEF-A Metacognitive index. CONCLUSIONS: These preliminary findings suggest that, in normal ageing, apathy may share an overlap with impulsivity, contradicting the notion they represent opposite ends of a single behavioural spectrum. Our results argue for bidirectional relationship between a specific apathy dimension (i.e. cognitive apathy) and executive functioning. Moreover, they shed new light on the underlying psychological process implicated (i.e. lack of perseverance) among older adults without dementia and represent an interesting prospect for psychological interventions.

Diagnostic Validity of the Sleep Condition Indicator to Screen for Diagnostic and Statistical Manual-5 Insomnia Disorder in Patients with Parkinson's Disease.

BACKGROUND: Insomnia is a highly common sleep disorder in patients with Parkinson's disease (PD). Yet, no screening questionnaires following the Diagnostic and Statistical Manual-5 (DSM-5) criteria have been validated in PD patients. OBJECTIVES: We assessed the validity and reliability of the French version of the sleep condition indicator (SCI), in patients with PD. METHODS: In a sample of 65 patients (46% women, mean age 63.8 ± 7.9 years) with PD, but without dementia, insomnia was assessed with a clinical interview and the SCI. Statistical analyses were performed to determine the reliability, construct validity, and divergent validity of the SCI. In addition, an explanatory factor analysis was performed to assess the underlying structure of the SCI. RESULTS: Of the 65 patients (mean duration PD 9.7 ± 6.9 years), 51% met the criteria for insomnia disorder when measured with a clinical interview. The mean SCI score was 18.05 ± 8.3. The internal consistency (α = 0.89) of the SCI was high. Using the previously defined cutoff value of ≤16, the area under the receiver operating characteristic curve was 0.86 with a sensitivity of 86% and a specificity of 87%. Exploratory factor analysis showed a 2-factor structure with a focus on sleep and daytime effects. Additionally, good construct and divergent validity were demonstrated. CONCLUSION: The SCI can be used as a valid and reliable screener for DSM-5 insomnia disorder in PD patients. Due to its short length, it is useful in both clinical practice and scientific research.

Positive and negative urgency as a single coherent construct: Evidence from a large-scale network analysis in clinical and non-clinical samples.

AIMS: Negative and positive urgency are emotion-related impulsivity traits that are thought to be transdiagnostic factors in psychopathology. However, it has recently been claimed that these two traits are closely related to each other and that considering them separately might have limited conceptual and methodological value. The present study aimed to examine whether positive and negative urgency constructs constitute separate impulsivity traits. METHODS: In contrast to previous studies that have used latent variable approaches, this study employed an item-based network analysis conducted in two different samples: a large sample of non-clinical participants (N = 18,568) and a sample of clinical participants with psychiatric disorders (N = 385). RESULTS: The network analysis demonstrated that items denoting both positive and negative urgency cohere as a single cluster of items termed "general urgency" in both clinical and non-clinical samples, thereby suggesting that differentiating positive and negative urgency as separate constructs is not necessary. CONCLUSION: These findings have important implications for the conceptualization and assessment of urgency and, more broadly, for future research on impulsivity, personality, and psychopathology.

Insomnia comorbid to Parkinson's disease Part II: Therapeutic approaches.

Insomnia is four times more frequent in patients with Parkinson's disease (PD) than in the general population. In PD, insomnia is associated with a very significant decrease in quality of life and has deleterious consequences on both patients' and caregivers' health. When insomnia is comorbid to PD, the main therapeutic response is the prescription of benzodiazepines or related drugs. As in the general population, these sedative-hypnotic molecules have very low efficacy in PD and are associated with adverse effects. They are highly addictive and are also associated with drowsiness, a risk of falling and decreased life expectancy. These side effects may in themselves be symptoms associated with PD in the absence of insomnia. In this clinical context, it is clear that sedative-hypnotic drugs are likely to potentiate these clinical symptoms in PD. We recently documented that insomnia disorder comorbid to PD is associated with the classic psychological factors that perpetuate insomnia in neurologically disease-free individuals with insomnia. These results enabled us to emphasise that target-oriented interventions, such as cognitive-behavioural therapy for chronic insomnia (CBT-i), should be considered as a treatment for insomnia comorbid to PD. As a reminder, for decades CBT-i has been considered to be the most effective first-line treatment for the management of chronic insomnia, whether or not it is associated with a comorbidity. In this context, we demonstrated the acceptability of CBT-i in the treatment of insomnia comorbid to PD and its effectiveness for the management of noctural and diurnal symptoms of insomnia associated with this neurological condition. The objective of this paper is to raise awareness among health professionals of the relevance of psychological therapies (mostly CBT) for insomnia in PD. Unlike drug treatments, these therapies are safe for patients who are already weakened by PD itself.

Interrater Variability in Pain Assessment of Long-term Care Residents with Dementia.

PURPOSE: People with dementia are at great risk of their pain being undetected. In long-term care facilities, certified nursing assistants are on the front-line to detect whether a resident with dementia is experiencing pain, but research on certified nursing assistants' abilities to accurately assess pain are scarce. This study aims to examine certified nursing assistants' pain assessment skills using a simulated standardized video context. DESIGN: A cross-sectional study was conducted. METHODS: Fifty certified nursing assistants and 40 individuals with no professional experience in the field of care (controls) watched the same video of an older adult woman with dementia experiencing pain. Afterwards, they completed visual analog scales (pain intensity, affective distress), an observational pain assessment scale (Algoplus), and a set of questionnaires. RESULTS: In both groups, pain intensity assessment and empathic reaction scores showed important interrater variability. Moreover, certified nursing assistants and controls did not differ in detecting the presence of pain or assessing its intensity. But certified nursing assistants displayed lower empathic reactions and dispositions. Certified nursing assistants pain assessment scores decreased with experience and expertise. CONCLUSIONS: The practice of pain assessment is challenging for certified nursing assistants in long-term care facilities. Their professional status does not prevent inter-personal inconsistency and tends to lower their empathic dispositions. Personal determinants may interfere with their assessment behaviors and must be considered to enhance pain management for residents with dementia.

Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY).

BACKGROUND: Fatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant proportion of people with schizophrenia (30-60%) reportedly experience fatigue, which impacts negatively on participation in various activities, including work, study, leisure, and social pursuits. Causes of fatigue in schizophrenia are poorly understood and there are no established treatments. Several evidence-based interventions for fatigue syndrome including psychoeducation, cognitive behavioral therapy, and graded exercise therapy have been shown to be effective in other medical conditions and could be adapted to address fatigue in schizophrenia patients. As there are no psychosocial or pharmacological interventions with proved efficacy for fatigue in schizophrenia, there is an urgent need for the development of strategies to improve fatigue management in schizophrenia. The aim of this project is to evaluate in a single blind randomized clinical trial the efficacy of a cognitive-behavioral therapy (CBT) intervention compared to treatment as usual (TAU) on fatigue as the main outcome in schizophrenia patients. Clinical symptoms, physical functioning, major cognitive functions, quality of life and functioning, treatment dosage, daily motor activity, biological markers with inflammatory markers are also considered as secondary outcomes. METHODS/DESIGN: Two hundred patients meeting the inclusion criteria will be randomized to either of the study arms (intervention or TAU). The ENERGY intervention will be delivered according to a standardized treatment manual comprising six modules addressing fatigue and sleep over 14 individual therapy sessions. The treatment encompasses core CBT principles of psycho-education, behavioral activation, behavioral experiments, cognitive restructuring, problem-solving, and relapse prevention. Sessions will follow the traditional CBT structure of agenda setting, review of homework tasks, and introduction of a new concept/technique with collaborative discussions on how to implement such strategies in the participant's day-to-day environment. Our primary endpoint will be the severity of fatigue assessed at baseline and at the 9-month follow-up using the "Multidimensional Fatigue Inventory" (MFI). DISCUSSION: The trial will provide the first test of CBT intervention for fatigue for patients with schizophrenia. This study will also test to what extent the treatment can be implemented in everyday practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT04332601 . Registered on 10 April 2020.