Daily electronic self-monitoring in bipolar disorder using smartphones – the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial

2015 ◽  
Vol 45 (13) ◽  
pp. 2691-2704 ◽  
Author(s):  
M. Faurholt-Jepsen ◽  
M. Frost ◽  
C. Ritz ◽  
E. M. Christensen ◽  
A. S. Jacoby ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Depressive Symptoms ◽  
Rating Scale ◽  
Group Analysis ◽  
Intervention Group ◽  
Patient Acceptance ◽  
Control Group ◽  
Self Monitoring ◽  
Manic Symptoms ◽  
Depressive And Manic Symptoms

BackgroundThe number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder.MethodA total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18–60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups.ResultsIntention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval −0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group.ConclusionsThese results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial

2019 ◽  
Vol 50 (5) ◽  
pp. 838-848 ◽  
Author(s):  
Maria Faurholt-Jepsen ◽  
Mads Frost ◽  
Ellen Margrethe Christensen ◽  
Jakob E. Bardram ◽  
Maj Vinberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bipolar Disorder ◽  
Perceived Stress ◽  
Intervention Group ◽  
Control Group ◽  
Manic Symptoms ◽  
Randomized Controlled ◽  
Depressive Episodes ◽  
Depressive And Manic Symptoms

AbstractBackgroundRecently, 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.MethodsRandomized 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.ResultsA 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.ConclusionsThere 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.

scholarly journals ‘Bipolarity’ in bipolar disorder: Distribution of manic and depressive symptoms in a treated population

2005 ◽  
Vol 187 (1) ◽  
pp. 87-88 ◽  
Author(s):  
Mark S. Bauer ◽  
Gregory E. Simon ◽  
Evette Ludman ◽  
Jurgen Unützer
Keyword(s):  
Bipolar Disorder ◽  
Depressive Symptoms ◽  
Health Maintenance Organisation ◽  
Cross Sectional ◽  
Health Maintenance ◽  
Manic Symptoms ◽  
Clinically Significant ◽  
Sectional Analysis ◽  
Depressive And Manic Symptoms

SummaryCross-sectional analysis of 441 individuals with bipolar disorder treated at a US health maintenance organisation investigated the distribution of manic and depressive symptoms in that illness. Clinically significant depressive symptoms occurred in 94.1% of those with (hypo)mania, while70.1% inadepressive episode had clinically significant manic symptoms. DSM-unrecognised depression-plus-hypomania was over twice as prevalent as DSM-recognised mixed episodes. Depressive symptoms were unimodally distributed in (hypo)mania. Depressive and manic symptoms were positively, not inversely correlated, and their co-occurrence was associated with worse quality of life. Implications for the DSM and ICD nosological systems are discussed.

scholarly journals 156 The Broad Efficacy of Cariprazine Across Symptoms in Patients with Bipolar I Disorder: Post Hoc Analysis of Randomized, Placebo-Controlled Trials

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 300-300
Author(s):  
Lakshmi N. Yatham ◽  
Eduard Vieta ◽  
Roger S. McIntyre ◽  
Rakesh Jain ◽  
Willie R. Earley ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Depressive Symptoms ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Partial Agonist ◽  
Controlled Trials ◽  
Bipolar I Disorder ◽  
Manic Symptoms ◽  
Bipolar Mania ◽  
Post Hoc

Abstract:Study Objective:Patients with bipolar disorder experience a wide range of depressive and manic symptoms. Only 2 drugs are FDA-approved to treat episodes of both mania and depression in patients with bipolar disorder, highlighting the need for treatments with proven efficacy at opposite poles of the bipolar spectrum. Cariprazine, a dopamine D3-preferring D3/D2 receptor partial agonist and serotonin 5-HT1A receptor partial agonist, is approved in the US for the treatment of both bipolar depression and manic and mixed episodes associated with bipolar I disorder. Cariprazine has previously demonstrated broad efficacy in patients with bipolar mania, with significantly greater improvement in favor of cariprazine vs placebo (PBO) across all individual symptom domains (P<.001) measured by the Young Mania Rating Scale (YMRS). Additionally, cariprazine has demonstrated efficacy vs PBO in 3 phase II/III clinical studies in patients with depressive episodes associated with bipolar I disorder (NCT01396447, NCT02670538, NCT02670551). To further assess the broad efficacy of cariprazine in patients with bipolar I disorder, we performed post hoc analyses to evaluate the range of depressive symptoms comprising the individual items of the Montgomery-Åsberg Depression Rating Scale (MADRS) in patients from the bipolar depression studies.Methods:Data from the 3 randomized, double-blind, PBO-controlled trials in patients with bipolar depression were pooled. Least squares (LS) mean change from baseline to week 6 in MADRS individual items was assessed in the pooled cariprazine 1.5 and 3 mg/d groups vs PBO using a mixed-effects model for repeated measures in the intent-to-treat (ITT) population.Results:There were 1383 patients in the ITT population (placebo=460; cariprazine 1.5-3 mg/d=923). At week 6, LS mean change from baseline was significantly greater for cariprazine 1.5-3 mg/d vs PBO on 9 of 10 individual MADRS items: Apparent Sadness (-2.0 vs -1.6, P<.0001); Reported Sadness (-2.0 vs -1.6, P<.0001); Reduced Sleep (-1.6 vs -1.4, P=.0357); Reduced Appetite (-1.2 vs -1.0, P=.0001); Concentration Difficulties (-1.5 vs -1.2, P=.0002); Lassitude (-1.7 vs -1.4, P=.0003); Inability To Feel (-1.7 vs -1.5, P=.0009); Pessimistic Thoughts (-1.4 vs -1.2, P=.0054) and Suicidal Thoughts (-0.3 vs -0.2, P=.0383); differences between cariprazine and PBO on the Inner Tension item were not significant.Conclusions:Significant improvement in most MADRS single items suggests broad efficacy in depressive symptoms for cariprazine 1.5-3 mg/d vs PBO in patients with bipolar depression. Coupled with broad efficacy in manic symptoms as demonstrated by significant improvement in all YMRS individual items in patients with bipolar mania or mixed episodes, cariprazine appears be effective across the range of symptoms that affect patients with bipolar disorder.Funding Acknowledgements:Supported by Allergan plc.

scholarly journals Associations between the cortisol awakening response and patient-evaluated stress and mood instability in patients with bipolar disorder: an exploratory study

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Maria Faurholt-Jepsen ◽  
Vibe Gedsø Frøkjær ◽  
Arafat Nasser ◽  
Niklas Rye Jørgensen ◽  
Lars Vedel Kessing ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Perceived Stress ◽  
Hpa Axis ◽  
Rating Scale ◽  
Clinical Care ◽  
Intervention Group ◽  
Cortisol Awakening Response ◽  
Control Group ◽  
Entire Study ◽  
Mood Instability

Abstract Objective The Cortisol Awakening Response (CAR) measured as the transient increase in cortisol levels following morning awakening appears to be a distinct feature of the HPA axis. Patients with bipolar disorder (BD) experience daily stress, mood instability (MI) and studies have shown disrupted HPA-axis dynamics. Aims: to evaluate (1) patient-evaluated stress against the CAR, (2) associations between the CAR and mood symptoms, and (3) the effect of smartphone-based treatment on the CAR. Methods Patients with BD (n = 67) were randomized to the use of daily smartphone-based monitoring (the intervention group) or to the control group for six months. Clinically rated symptoms according to the Hamilton Depression Rating Scale 17-items (HDRS), the Young Mania Rating Scale (YMRS), patient-evaluated perceived stress using Cohen’s Perceived Stress Scale (PSS) and salivary awakening cortisol samples used for measuring the CAR were collected at baseline, after three and six months. In the intervention group, smartphone-based data on stress and MI were rated daily during the entire study period. Results Smartphone-based patient-evaluated stress (B: 134.14, 95% CI: 1.35; 266.92, p = 0.048) and MI (B: 430.23, 95% CI: 52.41; 808.04, p = 0.026) mapped onto increased CAR. No statistically significant associations between the CAR and patient-evaluated PSS or the HDRS and the YMRS, respectively were found. There was no statistically significant effect of smartphone-based treatment on the CAR. Conclusion Our data, of preliminary character, found smartphone-based patient-evaluations of stress and mood instability as read outs that reflect CAR dynamics. Smartphone-supported clinical care did not in itself appear to disturb CAR dynamics.

Smartphone based treatment in bipolar disorder

2016 ◽  
Vol 33 (S1) ◽  
pp. S32-S33 ◽  
Author(s):  
M. Faurholt-Jepsen ◽  
M. Frost ◽  
J.E. Bardram ◽  
L.V. Kessing
Keyword(s):  
Bipolar Disorder ◽  
Controlled Trial ◽  
Self Monitoring ◽  
Health Technologies ◽  
Manic Symptoms ◽  
Randomized Controlled ◽  
Behavioral Activities ◽  
Competing Interest ◽  
Depressive And Manic Symptoms ◽  
Great Development

E-mental health technologies are under great development and the use is of these technologies is increasing rapidly.During this symposium, results from a randomized controlled trial investigating the effect of smartphone based electronic self-monitoring on the severity of depressive and manic symptoms will be presented and discussed.Further, we will present and discuss the use of automatically generated objective smartphone data on behavioral activities (e.g. social activities, mobility and physical activity) as electronic biomarkers of illness activity in bipolar disorder.Disclosure of interestThe authors have not supplied their declaration of competing interest.

The effectiveness of discharge planning and range of motion (ROM) training in increasing muscle strength of nonhemorrhagic stroke patients

2018 ◽  
Vol 2 (3) ◽  
pp. 57
Author(s):  
Mohamat Iskandar
Keyword(s):  
Muscle Strength ◽  
Range Of Motion ◽  
Rating Scale ◽  
Discharge Planning ◽  
Intervention Group ◽  
Sampling Technique ◽  
Control Group ◽  
Planning Program ◽  
Stroke Patients ◽  
Central Java

Background: Non-hemorrhagic stroke patients experience hemiparesis, an improper handling results in joint contractures. Discharge planning combined with a range of motion (ROM) training given to patients and their families are expected to improve muscle strength in patients after returning from the hospital. Aims: This study is to identify the effectiveness of discharge planning in increasing muscle strength. Methods: This is a quasi-experimental study with a pre-posttest design. A total of 34 respondents were selected by cluster random sampling technique, from RAA Soewondo Pati General Hospital of Pati, Central Java, Indonesia. The respondents were divided equally into two groups; an intervention group (N = 17) was given a discharge planning program together with stroke information and range of motion (ROM) training while the control group (N = 17) received a standard discharge planning available in the hospital. Further, Muscle Rating Scale (MRS) was employed to assess the muscle strength on the 2nd, 7th, and 14th day after discharge planning presented to the nonhemorrhagic stroke patients. Results: This present study clearly acknowledges the standard discharge planning program available in the hospital improve the muscle strength of the upper and lower extremity in the nonhemorrhagic stroke patients just 2nd day after the care (pretest), and the significant improvement was observed until the day 14. Moreover, combining the care with ROM training at the intervention group faster the recovery and the muscle strength improved significantly at the 7th day and continue increase at the day 14. Looking to the muscle strength since the 2nd day to the day 14, respectively the muscle strength of upper and lower limb at the control group improved at the point of 0.588 and 0.882, while at the group received the ROM training reached the value of 1.472 and 1.412. Conclusions: The ROM training combined to the current discharge planning program will faster the muscle strength recovery of the nonhemorrhagic stroke patients. This research provide insight how family plays important role to the success in monitoring the rehabilitation and recovery progress. 

A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling
Keyword(s):  
Heart Failure ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Self Management ◽  
Control Group ◽  
Patient Centered ◽  
Self Monitoring ◽  
Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

Recovery of the decline in activities of daily living after hospitalization through an individualized exercise programme: Secondary Analysis of a Randomized Clinical Trial

2021 ◽  
Author(s):  
Nicolás Martínez-Velilla ◽  
Mikel L Sáez de Asteasu ◽  
Robinson Ramírez-Vélez ◽  
Fabricio Zambom-Ferraresi ◽  
Antonio García-Hermoso ◽  
...  
Keyword(s):  
Exercise Training ◽  
Daily Living ◽  
Group Analysis ◽  
Intervention Group ◽  
Training Programme ◽  
Control Group ◽  
Bladder Control ◽  
Patient Profile ◽  
Climbing Stairs ◽  
Exercise Training Programme

Abstract Background During the period of hospitalization patients can develop functional decline. The main aim of our study was to assess the natural trajectory of each Activity of Daily Living (ADL) and to assess how in-hospital exercise could influence short-term trajectory of ADLs. Methods Acutely hospitalized patients (n=297, 56.5% women) were randomly assigned to the intervention or control (usual care) group within the first 48 hours of admission. An exercise training programme was prescribed in two daily sessions (morning and evening) of 20 minutes duration during 5–7 consecutive days for the intervention group. The primary end-point was the change in every ADL (assessed with the Barthel Index) from 2 weeks before admission to hospital discharge. Results Acute hospitalization per se led to significant in-patient’s functional ability impairment in ADLs during hospitalization, whereas the exercise intervention reversed this trend (3.7 points; 95% CI, 0.5 to 6.8 points). After analyzing the trajectory of each one of the ADLs, patients in the control group significantly worsened all activities, but with a different degree of loss. For the between-group analysis, significant differences were obtained in many ADLs including bathing, dressing, grooming, bladder control, toilet use, transfers, mobility and climbing stairs (p&lt;0.05). The control group had the greatest impairment in all domains analyzed (i.e., feeding, bathing, dressing, grooming, bowel control, bladder control, toilet use, transfers, mobility, and climbing stairs), p&lt;0.05. Conclusions An individualized multicomponent exercise training programme in older adults is effective to reverse the loss of specific ADLs that frequently occurs during hospitalization. Each patient profile should receive an individualized prescription of exercise during hospitalizations.

scholarly journals Effects of a psychosocial intervention at one-year follow-up in a PREDIMED-plus sample with obesity and metabolic syndrome

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Núria Mallorquí-Bagué ◽  
María Lozano-Madrid ◽  
Cristina Vintró-Alcaraz ◽  
Laura Forcano ◽  
Andrés Díaz-López ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Depressive Symptoms ◽  
Psychosocial Support ◽  
Food Addiction ◽  
Intervention Group ◽  
Control Group ◽  
Lifestyle Recommendations ◽  
One Year ◽  
Mediational Role

AbstractThis study examines if overweight/obesity are related to higher impulsivity, food addiction and depressive symptoms, and if these variables could be modified after 1 year of a multimodal intervention (diet, physical activity, psychosocial support). 342 adults (55–75 years) with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus Cognition study were randomized to the intervention or to the control group (lifestyle recommendations). Cognitive and psychopathological assessments were performed at baseline and after 1-year follow-up. At baseline, higher impulsivity was linked to higher food addiction and depressive symptoms, but not to body mass index (BMI). Food addiction not only predicted higher BMI and depressive symptoms, but also achieved a mediational role between impulsivity and BMI/depressive symptoms. After 1 year, patients in both groups reported significant decreases in BMI, food addiction and impulsivity. BMI reduction and impulsivity improvements were higher in the intervention group. Higher BMI decrease was achieved in individuals with lower impulsivity. Higher scores in food addiction were also related to greater post-treatment impulsivity. To conclude, overweight/obesity are related to higher impulsivity, food addiction and depressive symptoms in mid/old age individuals with MetS. Our results also highlight the modifiable nature of the studied variables and the interest of promoting multimodal interventions within this population.

scholarly journals Assessment of Acupuncture and Moxibustion Effects on the Electrophysiological Properties of the Ulnar Nerve: A Nerve Conduction Study

2018 ◽  
Vol 4 (3-4) ◽  
pp. 198-207 ◽  
Author(s):  
Sónia Chan ◽  
Sérgio Ferreira ◽  
Bruno Ramos ◽  
Maria João Santos ◽  
Luís Carlos Matos ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Ulnar Nerve ◽  
Rating Scale ◽  
Intervention Group ◽  
Maximum Amplitude ◽  
Numeric Rating Scale ◽  
Control Group ◽  
Reaction Velocity ◽  
Electrophysiological Properties ◽  
Acupuncture And Moxibustion

Background/Aims: Acupuncture and moxibustion, when used together, have act mechanically and thermally on treated reflexological areas. The main goal of this work was to evaluate the effects of acupuncture and moxibustion on the electrophysiological properties of the ulnar nerve. Methods: Electrical stimulation was applied to the ulnar nerve above the epi­condyle of 28 volunteers. A 20-V potential was applied, and after each 10 impulses it was increased by 10 V, up to a maximum of 80 V. At 20 and 80 V, the participants were asked to rate the discomfort from 0 to 10 on a Numeric Rating Scale for pain. After the first stimulation and data collection, the control group rested for 6 min, while the intervention group was submitted to acupuncture and moxibustion on Lingdao (HT 4). Following this period of time, a second electrical stimulation was performed on both groups. Results: The discomfort was greater in the intervention group during the second stimulation. The stimulus required to achieve the maximum amplitude decreased, but the changes were only statistically significant in the intervention group (p = 0.006). An increase in latency and a decrease in reaction velocity were noticed between the first and the second stimulation for both groups; however, only the control group presented statistically significant differences (p = 0.018 and p = 0.022, respectively). Conclusions: Acupuncture and moxibustion on HT 4 increased the electrical sensitivity, decreased the stimulus intensity to achieve the maximum amplitude, and avoided a significant increase in latency and decrease in reaction velocity in two consecutive electrical stimulations.

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