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INTRODUCTION: Valid and reliable methods for diagnosing depression are essential. The present study aimed to test the performance of a new diagnostic interview for depression focusing on the core symptoms of depression. METHOD: We developed a diagnostic interview for depression: the CORE Diagnostic Interview, CORE-DI, which assesses each of the core features of depression on the four dimensions: quality, reactivity, globality, and fluctuations over time. The diagnostic performance of this interview was tested in a clinical study including 83 individuals presenting with various depressive symptoms, who were interviewed independently (1) by means of the CORE-DI and the Mini-International Neuropsychiatric Interview (M.I.N.I.), and (2) by highly skilled specialists in depression representing gold standard diagnoses. RESULTS: We compared the outcome of the CORE-DI, the M.I.N.I., and the diagnosis made by clinicians, respectively, versus the gold standard diagnosis, using diagnostic efficiency statistics. The CORE-DI diagnosed depression with a high specificity (0.91, 95% CI: 0.85-0.97, for International Classification of Diseases [ICD]-10 criteria and 0.88, 95% CI: 0.81-0.95, for Diagnostic and Statistical Manual of Mental Disorders [DSM-5] criteria) compared to both M.I.N.I (specificity 0.44, 95% CI: 0.33-0.55) and clinical diagnoses (specificity 0.76, 95% CI: 0.67-0.85). The sensitivity of the CORE-DI was 0.61 (95% CI: 0.55-0.72) for ICD-10 criteria and 0.67 (95% CI: 0.57-0.77) for DSM-5 criteria. DISCUSSION/CONCLUSION: The CORE-DI increased the specificity of the depression diagnosis substantially compared to clinical diagnoses and the diagnoses obtained by M.I.N.I. The results point to the usefulness of an elaborated and systematic assessment of the core symptoms in the examination of patients with depressive symptoms and thereby indicate a way for further development of specific diagnostic tools for depression in both clinical and research settings. However, it should be noted that the sensitivity of the CORE-DI was modest, and the psychometric properties of the CORE-DI might be different in other settings with higher or lower prevalence or severity of depressive symptoms.
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Depressão , Depressão/diagnóstico , Manual Diagnóstico e Estatístico de Transtornos Mentais , Humanos , Entrevista Psicológica , Escalas de Graduação Psiquiátrica , Reprodutibilidade dos TestesRESUMO
Diagnostic evaluations and early interventions of patients with bipolar disorder (BD) rely on clinical evaluations. Smartphones have been proposed to facilitate continuous and fine-grained self-monitoring of symptoms. The present study aimed to (1) validate daily smartphone-based self-monitored mood, activity, and sleep, against validated questionnaires and clinical ratings in young patients with newly diagnosed BD, unaffected relatives (UR), and healthy controls persons (HC); (2) investigate differences in daily smartphone-based self-monitored mood, activity, and sleep in young patients with newly diagnosed BD, UR, and HC; (3) investigate associations between self-monitored mood and self-monitored activity and sleep, respectively, in young patients with newly diagnosed BD. 105 young patients with newly diagnosed BD, 24 UR and 77 HC self-monitored 2 to 1077 days (median [IQR] = 65 [17.5-112.5]). There was a statistically significantly negative association between the mood item on Hamilton Depression Rating Scale (HAMD) and smartphone-based self-monitored mood (B = - 0.76, 95% CI - 0.91; - 0.63, p < 0.001) and between psychomotor item on HAMD and self-monitored activity (B = - 0.44, 95% CI - 0.63; - 0.25, p < 0.001). Smartphone-based self-monitored mood differed between young patients with newly diagnosed BD and HC (p < 0.001), and between UR and HC (p = 0.008) and was positively associated with smartphone-based self-reported activity (p < 0.001) and sleep duration (p < 0.001). The findings support the potential of smartphone-based self-monitoring of mood and activity as part of a biomarker for young patients with BD and UR. Smartphone-based self-monitored mood is better to discriminate between young patients with newly diagnosed BD and HC, and between UR and HC, compared with smartphone-based activity and sleep.Trial registration clinicaltrials.gov NCT0288826.
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Transtorno Bipolar , Smartphone , Afeto , Transtorno Bipolar/diagnóstico , Feminino , Nível de Saúde , Humanos , SonoRESUMO
BACKGROUND: Recently, the MONARCA I randomized controlled trial (RCT) was the first to investigate the effect of smartphone-based monitoring in bipolar disorder (BD). Findings suggested that smartphone-based monitoring sustained depressive but reduced manic symptoms. The present RCT investigated the effect of a new smartphone-based system on the severity of depressive and manic symptoms in BD. METHODS: Randomized controlled single-blind parallel-group trial. Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs were randomized to the use of a smartphone-based system or to standard treatment for 9 months. Primary outcomes: differences in depressive and manic symptoms between the groups. RESULTS: A total of 129 patients with BD (ICD-10) were included. Intention-to-treat analyses showed no statistically significant effect of smartphone-based monitoring on depressive (B = 0.61, 95% CI -0.77 to 2.00, p = 0.38) and manic (B = -0.25, 95% CI -1.1 to 0.59, p = 0.56) symptoms. The intervention group reported higher quality of life and lower perceived stress compared with the control group. In sub-analyses, the intervention group had higher risk of depressive episodes, but lower risk of manic episodes compared with the control group. CONCLUSIONS: There was no effect of smartphone-based monitoring. In patient-reported outcomes, patients in the intervention group reported improved quality of life and reduced perceived stress. Patients in the intervention group had higher risk of depressive episodes and reduced risk of manic episodes. Despite the widespread use and excitement of electronic monitoring, few studies have investigated possible effects. Further studies are needed.
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Transtorno Bipolar/terapia , Smartphone , Adulto , Dinamarca , Depressão/psicologia , Feminino , Humanos , Masculino , Mania/psicologia , Pessoa de Meia-Idade , Qualidade de Vida , Método Simples-CegoRESUMO
OBJECTIVE: Mood instability in patients with bipolar disorder has been associated with impaired functioning and risk of relapse. The present study aimed to investigate whether increased mood instability is associated with increased perceived stress and impaired quality of life and functioning in patients with bipolar disorder. METHODS: A total of 84 patients with bipolar disorder used a smartphone-based self-monitoring system on a daily basis for 9 months. Data on perceived stress, quality of life, and clinically rated functioning were collected at five fixed time points for each patient during follow-up. A group of 37 healthy individuals served as a control comparison of perceived stress, quality of life, and psychosocial functioning. RESULTS: The majority of patients presented in full or partial remission. As hypothesized, mood instability was significantly associated with increased perceived stress (B: 10.52, 95% CI: 5.25; 15.77, P < 0.0001) and decreased quality of life (B: -12.17, 95% CI. -19.54; -4.79, P < 0.0001) and functioning (B: -12.04, 95% CI: -19.08; -4.99, P < 0.0001) in patients with bipolar disorder. There were no differences in mood instability according to prescribed psychopharmacological treatment. Compared with healthy individuals, patients reported substantially increased perceived stress and experienced decreased quality of life and decreased functioning based on researcher-blinded evaluation. CONCLUSION: Mood instability in bipolar disorder is associated with increased perceived stress and decreased quality of life and functioning even during full or partial remission. There is a need to monitor and identify subsyndromal inter-episodic symptoms. Future studies investigating the effect of treatment on mood instability are highly warranted.
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Afeto , Transtorno Bipolar/psicologia , Qualidade de Vida/psicologia , Estresse Psicológico/psicologia , Adulto , Transtorno Bipolar/fisiopatologia , Estudos de Casos e Controles , Avaliação Momentânea Ecológica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , SmartphoneRESUMO
OBJECTIVES: Objective methods are lacking for continuous monitoring of illness activity in bipolar disorder. Smartphones offer unique opportunities for continuous monitoring and automatic collection of real-time data. The objectives of the paper were to test the hypotheses that (i) daily electronic self-monitored data and (ii) automatically generated objective data collected using smartphones correlate with clinical ratings of depressive and manic symptoms in patients with bipolar disorder. METHODS: Software for smartphones (the MONARCA I system) that collects automatically generated objective data and self-monitored data on illness activity in patients with bipolar disorder was developed by the authors. A total of 61 patients aged 18-60 years and with a diagnosis of bipolar disorder according to ICD-10 used the MONARCA I system for six months. Depressive and manic symptoms were assessed monthly using the Hamilton Depression Rating Scale 17-item (HDRS-17) and the Young Mania Rating Scale (YMRS), respectively. Data are representative of over 400 clinical ratings. Analyses were computed using linear mixed-effect regression models allowing for both between individual variation and within individual variation over time. RESULTS: Analyses showed significant positive correlations between the duration of incoming and outgoing calls/day and scores on the HDRS-17, and significant positive correlations between the number and duration of incoming calls/day and scores on the YMRS; the number of and duration of outgoing calls/day and scores on the YMRS; and the number of outgoing text messages/day and scores on the YMRS. Analyses showed significant negative correlations between self-monitored data (i.e., mood and activity) and scores on the HDRS-17, and significant positive correlations between self-monitored data (i.e., mood and activity) and scores on the YMRS. Finally, the automatically generated objective data were able to discriminate between affective states. CONCLUSIONS: Automatically generated objective data and self-monitored data collected using smartphones correlate with clinically rated depressive and manic symptoms and differ between affective states in patients with bipolar disorder. Smartphone apps represent an easy and objective way to monitor illness activity with real-time data in bipolar disorder and may serve as an electronic biomarker of illness activity.
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Transtorno Bipolar , Monitorização Fisiológica , Smartphone/estatística & dados numéricos , Adolescente , Adulto , Transtorno Bipolar/diagnóstico , Transtorno Bipolar/psicologia , Autoavaliação Diagnóstica , Feminino , Humanos , Relações Interpessoais , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/instrumentação , Monitorização Fisiológica/métodos , Gravidade do Paciente , Escalas de Graduação Psiquiátrica , Estatística como AssuntoRESUMO
BACKGROUND: Rating scales used to assess the severity of depression e.g. the Hamilton Depression Rating Scale 17-item (HDRS-17) partly rely on the patient's subjective experience and reporting. Such subjective measures tend to have low reliability and adding objective measures to complement the assessment of depression severity would be a major step forward. AIMS: To investigate correlations between electronic monitoring of psychomotor activity and severity of depression according to HDRS-17. METHODS: A total of 36 patients with unipolar disorder (n = 18) or bipolar disorder (n = 18) and 31 healthy control persons aged 18-60 years were included. Psychomotor activity was measured using a combined heart rate and movement sensor device (Actiheart) for 3 consecutive days, 24 h a day. RESULTS: We found that sleeping heart rate (beats/min) correlated with HDRS-17 in both patients with unipolar disorder and bipolar disorder (unadjusted model: B = 0.46, 95% CI 0.037-0.89, P = 0.034). In contrast, correlations between activity energy expenditure (kJ/kg/day), cardio-respiratory fitness (mlO2/min/kg) and HDRS-17 were non-significant. CONCLUSIONS: These results suggest that measuring sleeping heart rate in non-experimental daily life could be an objective supplementary method to measure the severity of depression and perhaps indicate presence of insomnia.
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Transtorno Bipolar/diagnóstico , Transtorno Depressivo/diagnóstico , Escalas de Graduação Psiquiátrica , Desempenho Psicomotor/fisiologia , Adolescente , Adulto , Transtorno Bipolar/fisiopatologia , Transtorno Bipolar/psicologia , Estudos de Casos e Controles , Transtorno Depressivo/fisiopatologia , Transtorno Depressivo/psicologia , Feminino , Frequência Cardíaca/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Monitorização Ambulatorial/métodos , Reprodutibilidade dos Testes , Distúrbios do Início e da Manutenção do Sono/diagnóstico , Distúrbios do Início e da Manutenção do Sono/etiologia , Distúrbios do Início e da Manutenção do Sono/fisiopatologia , Adulto JovemRESUMO
BACKGROUND: Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed. Recently, the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms. The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes, but had fewer manic symptoms during the trial. It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage, social activity, physical activity, and mobility. The Monsenso system, for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial. METHODS: The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the control group during the trial. Ethical permission has been obtained. Positive, neutral and negative findings will be published. DISCUSSION: If the system is effective in reducing depressive and/or manic symptoms (and other symptoms of bipolar disorder) and the rate of episodes, there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT02221336. Registered 26th of September 2014.
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Transtorno Bipolar/diagnóstico , Telefone Celular/estatística & dados numéricos , Projetos de Pesquisa , Autocuidado/métodos , Índice de Gravidade de Doença , Adolescente , Adulto , Idoso , Transtorno Bipolar/epidemiologia , Transtorno Bipolar/psicologia , Comunicação , Comorbidade , Dinamarca/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Participação do Paciente/métodos , Participação do Paciente/psicologia , Participação do Paciente/estatística & dados numéricos , Qualidade de Vida/psicologia , Autocuidado/psicologia , Autocuidado/estatística & dados numéricos , Método Simples-Cego , Comportamento Social , Estresse Psicológico/epidemiologia , Estresse Psicológico/psicologia , Adulto JovemRESUMO
Current evidence for pharmacological treatment of mania during hospitalisation is insufficient as there are no larger well-designed randomised trials of comparative medical treatments of mania during inpatient stays. Moreover, there is considerable variation in pharmacological medication in clinical practice during hospitalisation for mania. Based on a hospital data overview, a systematic search of the literature and a three-day consensus meeting, this narrative review proposed an algorithm for optimised pharmacological treatment of mania during hospitalisation and its subsequent scientific evaluation.
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Algoritmos , Hospitalização , Mania , Humanos , Mania/tratamento farmacológico , Antipsicóticos/uso terapêutico , Antimaníacos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Transtorno Bipolar/terapiaRESUMO
BACKGROUND: Little is known about whether treatment in a specialised out-patient mood disorder clinic improves long-term prognosis for patients discharged from initial psychiatric hospital admissions for bipolar disorder. AIMS: To assess the effect of treatment in a specialised out-patient mood disorder clinic v. standard decentralised psychiatric treatment among patients discharged from one of their first three psychiatric hospital admissions for bipolar disorder. METHOD: Patients discharged from their first, second or third hospital admission with a single manic episode or bipolar disorder were randomised to treatment in a specialised out-patient mood disorder clinic or standard care (ClinicalTrials.gov: NCT00253071). The primary outcome measure was readmission to hospital, which was obtained from the Danish Psychiatric Central Register. RESULTS: A total of 158 patients with mania/bipolar disorder were included. The rate of readmission to hospital was significantly decreased for patients treated in the mood disorder clinic compared with standard treatment (unadjusted hazard ratio 0.60, 95% CI 0.37-0.97, P = 0.034). Patients treated in the mood disorder clinic more often used a mood stabiliser or an antipsychotic and satisfaction with treatment was more prevalent than among patients who received standard care. CONCLUSIONS: Treatment in a specialised mood disorder clinic early in the course of bipolar disorder substantially reduces readmission to a psychiatric hospital and increases satisfaction with care.
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Assistência Ambulatorial/métodos , Transtorno Bipolar/terapia , Hospitalização/estatística & dados numéricos , Hospitais Psiquiátricos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Adolescente , Adulto , Idoso , Assistência Ambulatorial/economia , Instituições de Assistência Ambulatorial , Antimaníacos/uso terapêutico , Antipsicóticos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Transtorno Bipolar/economia , Dinamarca , Feminino , Seguimentos , Custos de Cuidados de Saúde , Hospitalização/economia , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Educação de Pacientes como Assunto , Psicoterapia de Grupo/métodos , Recidiva , Tempo para o Tratamento , Adulto JovemRESUMO
BACKGROUND: Alterations and instability in mood and activity/energy has been associated with impaired functioning and risk of relapse in bipolar disorder. The present study aimed to investigate whether mood instability and activity/energy instability are associated, and whether these instability measures are associated with stress, quality of life and functioning in patients with bipolar disorder. METHODS: Data from two studies were combined for exploratory post hoc analyses. Patients with bipolar disorder provided smartphone-based evaluations of mood and activity/energy levels from day-to-day. In addition, information on functioning, perceived stress and quality of life was collected. A total of 316 patients with bipolar disorder were included. RESULTS: A total of 55,968 observations of patient-reported smartphone-based data collected from day-to-day were available. Regardless of the affective state, there was a statistically significant positive association between mood instability and activity/energy instability in all models (all p-values < 0.0001). There was a statistically significant association between mood and activity/energy instability with patient-reported stress and quality of life (e.g., mood instability and stress: B: 0.098, 95 % CI: 0.085; 0.11, p < 0.0001), and between mood instability and functioning (B: 0.045, 95 % CI: 0.0011; 0.0080, p = 0.010). LIMITATIONS: Findings should be interpreted with caution since the analyses were exploratory and post hoc by nature. CONCLUSION: Mood instability and activity/energy instability is suggested to play important roles in the symptomatology of bipolar disorder. This highlight that monitoring and identifying subsyndromal inter-episodic fluctuations in symptoms is clinically recommended. Future studies investigating the effect of treatment on these measures would be interesting.
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Transtorno Bipolar , Humanos , Transtorno Bipolar/psicologia , Smartphone , Qualidade de Vida/psicologia , Afeto , EmoçõesRESUMO
INTRODUCTION: A substantial proportion of patients with bipolar disorder experience daily subsyndromal mood swings, and the term "mood instability" reflecting the variability in mood seems associated with poor prognostic factors, including impaired functioning, and increased risk of hospitalization and relapse. During the last decade, we have developed and tested a smartphone-based system for monitoring bipolar disorder. The present SmartBipolar randomized controlled trial (RCT) aims to investigate whether (1) daily smartphone-based outpatient monitoring and treatment including clinical feedback versus (2) daily smartphone-based monitoring without clinical feedback or (3) daily smartphone-based mood monitoring only improves mood instability and other clinically relevant patient-related outcomes in patients with bipolar disorder. METHODS AND ANALYSIS: The SmartBipolar trial is a pragmatic randomized controlled parallel-group trial. Patients with bipolar disorder are invited to participate as part of their specialized outpatient treatment for patients with bipolar disorder in Mental Health Services in the Capital Region of Denmark. The included patients will be randomized to (1) daily smartphone-based monitoring and treatment including a clinical feedback loop (intervention group) or (2) daily smartphone-based monitoring without a clinical feedback loop (control group) or (3) daily smartphone-based mood monitoring only (control group). All patients receive specialized outpatient treatment for bipolar disorder in the Mental Health Services in the Capital Region of Denmark. The trial started in March 2021 and has currently included 150 patients. The outcomes are (1) mood instability (primary), (2) quality of life, self-rated depressive symptoms, self-rated manic symptoms, perceived stress, satisfaction with care, cumulated number and duration of psychiatric hospitalizations, and medication (secondary), and (3) smartphone-based measures per month of stress, anxiety, irritability, activity, and sleep as well as the percentage of days with presence of mixed mood, days with adherence to medication and adherence to smartphone-based self-monitoring. A total of 201 patients with bipolar disorder will be included in the SmartBipolar trial. ETHICS AND DISSEMINATION: The SmartBipolar trial is funded by the Capital Region of Denmark and the Independent Research Fund Denmark. Ethical approval has been obtained from the Regional Ethical Committee in The Capital Region of Denmark (H-19067248) as well as data permission (journal number: P-2019-809). The results will be published in peer-reviewed academic journals, presented at scientific meetings, and disseminated to patients' organizations and media outlets. TRIAL REGISTRATION: Trial registration number: NCT04230421. Date March 1, 2021. Version 1.
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Transtorno Bipolar , Humanos , Transtorno Bipolar/diagnóstico , Transtorno Bipolar/terapia , Retroalimentação , Smartphone , Assistência Ambulatorial , Transtornos do Humor , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Alterations in energy and activity in bipolar disorder (BD) differ between affective states and compared with healthy control individuals (HC). Measurements of activity could discriminate between BD and HC and in the monitoring of affective states within BD. The aims were to investigate differences in 1) passively collected smartphone-based location data (location data) between BD and HC, and 2) location data in BD between affective states. METHODS: Daily, patients with BD and HC completed smartphone-based self-assessments of mood for up to nine months. Location data reflecting mobility patterns, routine and location entropy was collected daily. A total of 46 patients with BD and 31 HC providing daily data was included. RESULTS: A total of 4,859 observations of smartphone-based self-assessments of mood and mobility patterns were available from patients with BD and 1,747 observations from HC. Patients with BD had lower location entropy compared with HC (B= -0.14, 95% CI= -0.24; -0.034, p=0.009). Patients with BD during a depressive state were less mobile compared with a euthymic state. Patients with BD during an affective state had lower location entropy compared with a euthymic state (p<0.0001). The AUC of combined location data was rather high in classifying patients with BD compared with HC (AUC: 0.83). LIMITATIONS: Individuals willing to use smartphones for daily self-monitoring may represent a more motivated group. CONCLUSION: Alterations in location data reflecting mobility patterns may be a promising measure of illness and illness activity in patients with BD and may be used to monitor the effects of treatments.
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Transtorno Bipolar , Afeto , Transtorno Ciclotímico , Humanos , Autoavaliação (Psicologia) , SmartphoneRESUMO
INTRODUCTION: Despite current available treatment patients with bipolar disorder often experience relapses and decreased overall functioning. Furthermore, patients with bipolar disorder are often not treated medically or psychologically according to guidelines and recommendations. A Clinical Academic Group is a new treatment initiative bringing together clinical services, research, education and training to offer care and treatment that is based on reliable evidence backed up by research. The present Clinical Academic Group for bipolar disorder (the CAG Bipolar) randomised controlled trial (RCT) aims for the first time to investigate whether specialised outpatient treatment in CAG Bipolar versus generalised community-based treatment improves patient outcomes and clinician's satisfaction with care in patients with bipolar disorder. METHODS AND ANALYSIS: The CAG Bipolar trial is a pragmatic randomised controlled parallel-group trial undertaken in the Capital Region of Denmark covering a catchment area of 1.85 million people. Patients with bipolar disorder are invited to participate as part of their outpatient treatment in the Mental Health Services. The included patients will be randomised to (1) specialised outpatient treatment in the CAG Bipolar (intervention group) or (2) generalised community-based outpatient treatment (control group). The trial started 13 January 2020 and has currently included more than 600 patients. The outcomes are (1) psychiatric hospitalisations and cumulated number and duration of psychiatric hospitalisations (primary), and (2) self-rated depressive symptoms, self-rated manic symptoms, quality of life, perceived stress, satisfaction with care, use of medication and the clinicians' satisfaction with their care (secondary). A total of 1000 patients with bipolar disorder will be included. ETHICS AND DISSEMINATION: The CAG Bipolar RCT is funded by the Capital Region of Denmark and ethical approval has been obtained from the Regional Ethical Committee in The Capital Region of Denmark (H-19067248). Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets. TRIAL REGISTRATION NUMBER: NCT04229875.
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Transtorno Bipolar , Assistência Ambulatorial , Transtorno Bipolar/tratamento farmacológico , Humanos , Recidiva Local de Neoplasia , Pacientes Ambulatoriais , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de PesquisaRESUMO
BACKGROUND: Cognitive impairments in patients with bipolar disorder (BD) have been associated with reduced functioning. AIMS: To investigate the association between (1) patient-evaluated cognitive function measured daily using smartphones and stress, quality of life and functioning, respectively, and (2) patient-evaluated cognitive function and objectively measured cognitive function with neuropsychological tests. METHODS: Data from two randomized controlled trials were combined. Patients with BD (N = 117) and healthy controls (HC) (N = 40) evaluated their cognitive function daily for six to nine months using a smartphone. Patients completed the objective cognition screening tool, the Screen for Cognitive Impairment in Psychiatry and were rated with the Functional Assessment Short Test. Raters were blinded to smartphone data. Participants completed the Perceived Stress Scale and the WHO Quality of Life questionnaires. Data was collected at multiple time points per participant. p-values below 0.0023 were considered statistically significant. RESULTS: Patient-evaluated cognitive function was statistically significant associated with perceived stress, quality of life and functioning, respectively (all p-values < 0.0001). There was no association between patient-evaluated cognitive function and objectively measured cognitive function (B:0.0009, 95% CI 0.0017; 0.016, p = 0.015). Patients exhibited cognitive impairments in subjectively evaluated cognitive function in comparison with HC despite being in full or partly remission (B: - 0.36, 95% CI - 0.039; - 0.032, p < 0.0001). CONCLUSION: The present association between patient-evaluated cognitive function on smartphones and perceived stress, quality of life and functional capacity suggests that smartphones can provide a valid tool to assess disability in remitted BD. Smartphone-based ratings of cognition could not provide insights into objective cognitive function.
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BACKGROUND: Non-adherence to medication is associated with increased risk of relapse in patients with bipolar disorder (BD). OBJECTIVES: To (1) validate patient-evaluated adherence to medication measured via smartphones against validated adherence questionnaire; and (2) investigate characteristics for adherence to medication measured via smartphones. METHODS: Patients with BD (n=117) evaluated adherence to medication daily for 6-9 months via smartphones. The Medication Adherence Rating Scale (MARS) and the Rogers' Empowerment questionnaires were filled out. The 17-item Hamilton Depression Rating Scale, the Young Mania Rating Scale and the Functional Assessment Short Test were clinically rated. Data were collected multiple times per patient. The present study represents exploratory pooled reanalyses of data collected as part of two randomised controlled trials. FINDINGS: During the study 90.50% of the days were evaluated as 'medication taken', 6.91% as 'medication taken with changes' and 2.59% as 'medication not taken'. Adherence to medication measured via smartphones was valid compared with the MARS (B: -0.049, 95% CI -0.095 to -0.003, p=0.033). Younger age and longer illness duration were significant predictors for non-adherence to medication (model concerning age: B: 0.0039, 95% CI 0.00019 to 0.0076, p=0.040). Decreased affective symptoms measured with smartphone-based patient-reported mood and clinical ratings as well as decreased empowerment were associated with non-adherence. CONCLUSIONS: Smartphone-based monitoring of adherence to medication was valid compared with validated adherence questionnaire. Younger age and longer illness duration were predictors for non-adherence. Increased empowerment was associated with adherence. CLINICAL IMPLICATIONS: Using smartphones for empowerment of adherence using patient-reported measures may be helpful in everyday clinical settings. TRIAL REGISTRATION NUMBER: NCT01446406 and NCT02221336.
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Transtorno Bipolar/tratamento farmacológico , Adesão à Medicação , Psicometria/normas , Autorrelato/normas , Adulto , Fatores Etários , Feminino , Humanos , Masculino , Psicometria/instrumentação , Reprodutibilidade dos Testes , Smartphone , Adulto JovemRESUMO
INTRODUCTION: The DSM-5 has introduced elevated/irritable mood and increased activity/ energy as equal and necessary criterion A symptoms for a diagnosis of (hypo)mania. The impact of these changes is poorly elucidated. The aim of the study was to investigate differences in the prevalence of elevated/irritable mood with and without co-occurring increased activity, and the associations between these, in patients with an ICD-10 and DSM-IV diagnosis of BD, using real life daily smartphone-based patient-reported measures of mood, irritability and activity. METHODS: Data from two RCTs investigating the effect of smartphone-based treatment in patients with BD were combined. Patients with BD (N = 117) evaluated mood, irritability and activity level daily for six to nine months via a smartphone-based system. Analyses in this study are exploratory post hoc analyses based on previously published data. RESULTS: During the follow-up period, patients reported elevated mood 8.0% of the time, irritability 28.4% of the time and increased activity 20.6% of the time. Co-occurring elevated/irritable mood and activity were prevalent 0.12% of the time for four consecutive days (duration criteria for a hypomanic episode) compared to 24% of the time with elevated/irritable mood without co-occurring increased activity. In linear mixed effect models accommodating for inter-individual and intra-individual variation, there was a statistically significant positive association between mood and activity (B: 0.14, 95% CI: 0.046; 0.24, p = 0.004). There was no association between irritability and activity (p = 0.23). CONCLUSION: Based on real life daily assessments, the prevalence of (hypo)manic episodes is substantial reduced as a result of the introduction of DSM-5 and with potentially clinical consequences.
Assuntos
Transtorno Bipolar , Mania , Transtorno Bipolar/diagnóstico , Transtorno Bipolar/epidemiologia , Manual Diagnóstico e Estatístico de Transtornos Mentais , Humanos , Medidas de Resultados Relatados pelo Paciente , SmartphoneRESUMO
OBJECTIVES: To investigate whether mood instability (MI) qualify as a trait marker for bipolar disorder (BD) we investigated: 1) differences in smartphone-based self-reported MI between three groups: patients with newly diagnosed BD, unaffected first-degree relatives (UR), and healthy control individuals (HC); 2) the correlation between MI and functioning, stress, and duration of illness, respectively; and 3) the validity of smartphone-based self-evaluated mood ratings as compared to observer-based ratings of depressed and manic mood. METHODS: 203 patients with newly diagnosed BD, 54 UR and 109 HC were included as part of the longitudinal Bipolar Illness Onset study. Participants completed daily smartphone-based mood ratings for a period of up to two years and were clinically assessed with ratings of depression, mania and functioning. RESULTS: Mood instability scores were statistically significantly higher in patients with BD compared with HC (mean=1.18, 95%CI: 1.12;1.24 vs 1.05, 95%CI: 0.98;1.13, p = 0.007) and did not differ between patients with BD and UR (mean=1.17, 95%CI: 1.07;1.28, p = 0.91). For patients, increased MI scores correlated positively with impaired functioning (p<0.001), increased stress level (p<0.001) and increasing number of prior mood episodes (p<0.001). Smartphone-based mood ratings correlated with ratings of mood according to sub-item 1 on the Hamilton Depression Rating Scale 17-items and the Young Mania Rating Scale, respectively (p´s<0.001). LIMITATION: The study had a smaller number of UR than planned. CONCLUSION: Mood instability is increased in patients with newly diagnosed BD and unaffected relatives and associated with decreased functioning. The findings highlight MI as a potential trait marker for BD.
Assuntos
Transtorno Bipolar , Afeto , Transtorno Bipolar/diagnóstico , Humanos , Autorrelato , SmartphoneRESUMO
BACKGROUND: The efficacy of antidepressant treatment is fair, but the efficacy is considerably lower in patients failing two or more trials underscoring the need for new treatment options. Our study evaluated the augmenting antidepressant effect of 8-weeks transcranial pulsed electromagnetic field (T-PEMF) therapy in patients with treatment-resistant depression. METHODS: A multicenter 8-week single-arm cohort study conducted by the Danish University Antidepressant Group. RESULTS: In total, 58 participants (20 men and 38 women) with a moderate to severe depression as part of a depressive disorder according to ICD-10 who fulfilled criteria for treatment resistance were included, with 19 participants being nonresponders to electroconvulsive therapy during the current depressive episode. Fifty-two participants completed the study period. Scores on the Hamilton Depression Scale 17-items version (HAM-D17) decreased significantly from baseline (mean = 20.6, SD 4.0) to endpoint (mean = 12.6, SD 7.1; N = 58). At endpoint, utilizing a Last Observation Carried Forward analysis, 49 and 28% of those participants with, respectively, a nonchronic current episode (≤2 years; N = 33) and a chronic current episode (>2 years; N = 25) were responders, that is, achieved a reduction of 50% or more on the HAM-D17 scale. At endpoint, respectively, 30 and 16% obtained remission, defined as HAM-D17 ≤ 7. On the Hamilton Scale 6-item version (HAM-D6), respectively, 51 and 16% obtained remission, defined as HAM-D6 ≤ 4. CONCLUSIONS: The findings indicate a potential beneficial role of T-PEMF therapy as an augmentation treatment to ongoing pharmacotherapy in treatment-resistant depression.
Assuntos
Transtorno Depressivo Resistente a Tratamento/terapia , Eletroconvulsoterapia/métodos , Estimulação Magnética Transcraniana/métodos , Adulto , Antidepressivos/uso terapêutico , Estudos de Coortes , Campos Eletromagnéticos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Escalas de Graduação Psiquiátrica , Resultado do TratamentoRESUMO
BACKGROUND: Mood instability in bipolar disorder is associated with a risk of relapse. This study investigated differences in mood instability between patients with bipolar disorder type I and type II, which previously has been sparingly investigated. METHODS: Patients with bipolar disorder type I (n = 53) and type II (n = 31) used a daily smartphone-based self-monitoring system for 9 months. Data in the present reflect 15.975 observations of daily collected smartphone-based data on patient-evaluated mood. RESULTS: In models adjusted for age, gender, illness duration and psychopharmacological treatment, patients with bipolar disorder type II experienced more mood instability during depression compared with patients with bipolar disorder type I (B: 0.27, 95% CI 0.007; 0.53, p = 0.044), but lower intensity of manic symptoms. Patients with bipolar disorder type II did not experience lower mean mood or higher intensity of depressive symptoms compared with patients with bipolar disorder type I. CONCLUSIONS: Compared to bipolar disorder type I, patients with bipolar disorder type II had higher mood instability for depression. Clinically it is of importance to identify these inter-episodic symptoms. Future studies investigating the effect of treatment on mood instability measures are warranted. Trial registration NCT02221336.
RESUMO
Following publication of the original article [1], the authors notified us that a comment in the Peripheral and neural biomarkers and genotype section was incorrectly phrased during editing. "4 weeks of treatment (four active ABCR sessions twice a week or control group sessions twice a week)" should have actually been described as "4 weeks of treatment (4 active, twice a week, ABCR sessions or 2 weekly control group sessions)".