Smartphone based treatment in bipolar disorder

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.

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

Psychological Medicine ◽

10.1017/s0033291715000410 ◽

2015 ◽

Vol 45 (13) ◽

pp. 2691-2704 ◽

Cited By ~ 77

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.

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Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/resprot.9899 ◽

2018 ◽

Vol 7 (5) ◽

pp. e130 ◽

Cited By ~ 5

Author(s):

Amy Cochran ◽

Livia Belman-Wells ◽

Melvin McInnis

Keyword(s):

Bipolar Disorder ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Wearable Technology ◽

Self Monitoring ◽

Randomized Controlled ◽

Engagement Strategies

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Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial of LiveWell: A Smartphone-based Self-management Intervention for Individuals with Bipolar Disorder (Preprint)

10.2196/preprints.30710 ◽

2021 ◽

Author(s):

Evan H Goulding ◽

Cynthia Dopke ◽

Rebecca Rossom ◽

Tania Michaels ◽

Clair Martin ◽

...

Keyword(s):

Bipolar Disorder ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Symptom Burden ◽

Self Report ◽

Self Management ◽

Relapse Risk ◽

Health Technologies ◽

Randomized Controlled ◽

Empirically Supported

BACKGROUND Bipolar disorder is a severe mental illness with high levels of morbidity and mortality. Even with pharmacologic treatment, frequent recurrence of episodes, long episode durations, and persistent inter-episode symptoms are common and disruptive. Combining psychotherapy with pharmacotherapy improves outcomes, but access to therapy is limited and many individuals with bipolar disorder do not receive psychotherapy. Mental health technologies can increase access to self-management strategies derived from empirically supported bipolar disorder psychotherapies while also enhancing treatment by delivering real-time assessments, personalized feedback, and provider alerts. In addition, mental health technologies provide a platform for self-report, application use, and behavioral data collection to advance understanding of the longitudinal course of bipolar disorder which can then be utilized to support ongoing improvement of treatment. OBJECTIVE To facilitate the ability to replicate, improve, implement and disseminate effective interventions for bipolar disorder, we provide a description of the theoretical and empirically supported framework, design, and protocol for a randomized controlled trial of LiveWell: a smartphone-based self-management intervention for individuals with bipolar disorder. The goal of this trial is to determine the effectiveness of LiveWell for reducing relapse risk and symptom burden, while simultaneously elucidating behavioral targets of the intervention and better characterizing bipolar disorder course and treatment response. METHODS The study is a single blind randomized controlled trial (N = 205, 2:3 ratio of usual care vs usual care plus LiveWell). The primary outcome is time to relapse. Secondary outcomes are percent time symptomatic, symptom severity, and quality of life. Longitudinal changes in target behaviors proposed to mediate the primary and secondary outcomes will also be determined and their relationships with the outcomes will be assessed. A database of clinical status, symptom severity, real-time self-report, behavioral sensor, application use and personalized content will be created with the aim of better predicting treatment response and relapse risk. RESULTS Recruitment and screening started in March 2017 and ended in April 2019. Follow up ended April 2020. The study results are expected to be published in 2021. CONCLUSIONS This study will examine the potential of LiveWell for reducing relapse risk and symptom burden in individuals with bipolar disorder by increasing access to empirically supported self-management strategies. Simultaneously, a database will be created to initiate development of algorithms to personalize and improve treatment for bipolar disorder. Additionally, we hope that the description of the theoretical and empirically supported framework, intervention design, and study protocol for the randomized controlled trial of LiveWell provided here will facilitate the ability to replicate, improve, implement and disseminate effective interventions for bipolar disorder. CLINICALTRIAL ClinicalTrials.gov NCT03088462

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

Psychological Medicine ◽

10.1017/s0033291719000710 ◽

2019 ◽

Vol 50 (5) ◽

pp. 838-848 ◽

Cited By ~ 18

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.

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Interpretation Bias Training for Bipolar Disorder: A Randomized Controlled Trial

Journal of Affective Disorders ◽

10.1016/j.jad.2020.12.162 ◽

2020 ◽

Author(s):

Anna Van Meter ◽

Joel Stoddard ◽

Ian Penton-Voak ◽

Marcus R Munafò

Keyword(s):

Bipolar Disorder ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Interpretation Bias ◽

Randomized Controlled

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Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: A pilot randomized controlled trial.

Journal of Consulting and Clinical Psychology ◽

10.1037/a0038655 ◽

2015 ◽

Vol 83 (3) ◽

pp. 564-577 ◽

Cited By ~ 100

Author(s):

Allison G. Harvey ◽

Adriane M. Soehner ◽

Kate A. Kaplan ◽

Kerrie Hein ◽

Jason Lee ◽

...

Keyword(s):

Bipolar Disorder ◽

Randomized Controlled Trial ◽

Mood State ◽

Controlled Trial ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

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Cognitive Analytic Therapy for Bipolar Disorder: A Pilot Randomized Controlled Trial

Clinical Psychology & Psychotherapy ◽

10.1002/cpp.2065 ◽

2016 ◽

Vol 24 (1) ◽

pp. 22-35 ◽

Cited By ~ 7

Author(s):

Mark Evans ◽

Stephen Kellett ◽

Simon Heyland ◽

Jo Hall ◽

Shazmin Majid

Keyword(s):

Bipolar Disorder ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Randomized Controlled ◽

Analytic Therapy ◽

Cognitive Analytic Therapy ◽

Pilot Randomized Controlled Trial

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Protocol for the MobiMD trial: A randomized controlled trial to evaluate the effect of a self-monitoring mobile app on hospital readmissions for complex surgical patients

Contemporary Clinical Trials ◽

10.1016/j.cct.2021.106658 ◽

2021 ◽

pp. 106658

Author(s):

Thomas M. Diehl ◽

James R. Barrett ◽

Daniel E. Abbott ◽

Linda M. Cherney Stafford ◽

Bret M. Hanlon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Hospital Readmissions ◽

Mobile App ◽

Surgical Patients ◽

Self Monitoring ◽

Randomized Controlled

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The Effectiveness of a Smartphone Application on Modifying the Intakes of Macro and Micronutrients in Primary Care: A Randomized Controlled Trial. The EVIDENT II Study

Nutrients ◽

10.3390/nu10101473 ◽

2018 ◽

Vol 10 (10) ◽

pp. 1473 ◽

Cited By ~ 3

Author(s):

Jose Recio-Rodriguez ◽

Cristina Agudo Conde ◽

Maria Calvo-Aponte ◽

Natividad Gonzalez-Viejo ◽

Carmen Fernandez-Alonso ◽

...

Keyword(s):

Primary Care ◽

Repeated Measures ◽

Controlled Trial ◽

Smartphone Application ◽

Nutritional Composition ◽

Lower Percentage ◽

Self Monitoring ◽

Randomized Controlled ◽

Saturated Fats ◽

Counseling Group

Background: This study evaluates the effectiveness of adding a diet smartphone application to standard counseling to modify dietary composition over the long term (12 months). Methods: A randomized, controlled, multicenter clinical trial was conducted involving the participation of 833 subjects from primary care clinics (415 to the intervention (counseling + application) group (IG) and 418 to the control (counseling) group (CG)). Both groups were counseled about a healthy diet and physical activity. For the 3-month intervention period, the IG was also trained to use a diet smartphone application that involved dietary self-monitoring and tailored feedback. Nutritional composition was estimated using a self-reported food frequency questionnaire. Results: An analysis of repeated measures revealed an interaction between the group and the percentages of carbohydrates (p = 0.031), fats (p = 0.015) and saturated fats (p = 0.035) consumed. Both groups decreased their energy intake (Kcal) at 12 months (IG: −114 (95% CI: −191 to −36); CG: −108 (95% CI: −184 to −31)). The IG reported a higher percentage intake of carbohydrates (1.1%; 95% CI: 0.1 to 2.0), and lower percentage intakes of fats (−1.0%; 95% CI: −1.9 to −0.1) and saturated fats (−0.4%; 95%CI: −0.8 to −0.1) when compared to the CG. Conclusions: Better results were achieved in terms of modifying usual diet composition from counseling and the diet smartphone application compared to counseling alone. This was evaluated by a self-reported questionnaire, which indicated an increased percentage intake of carbohydrates, and decreased percentage intakes of fats and saturated fats.

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