Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar

Study Overview
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Brief Summary
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The Smart Bipolar RCT is a pragmatic RCT aiming to investigate effects of smartphone-based add on treatment in large scale clinical practice (N= 200 patients).

Detailed Description
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Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed, and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. IT solutions have during recent years emerged as a possible way to optimize treatment, but the effects of digital health interventions are rarely investigated scientifically in health care services. This is an application from the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region. The Smart Bipolar randomized controlled trial is a pragmatic trial aiming to investigate the effects of smartphone-based add-on treatment in large-scale clinical practice (N= 200 patients). Findings from the study will have a great impact on future IT monitoring and treatment in bipolar disorder.

Official Title
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Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Device: The Monsenso system with feedback
* Device: The Monsenso system without feedback
* Device: CAG Bipola and mood monitoring only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients in CAG Bipolar, i.e., with a main diagnosis of bipolar disorder in the five large centers, in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hilleroed, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup) Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monsenso with feedback<br>Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback. | Device: The Monsenso system with feedback<br>* See description under intervention<br>|
| Active Comparator: Monsenso without feedback<br>Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback. | Device: The Monsenso system without feedback<br>* See description under intervention<br>|
| Active Comparator: Control<br>CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system. | Device: CAG Bipola and mood monitoring only<br>* See description under intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily self-reported mood instability via Monsenso | Mood measured daily via smartphones on a scale form -3 to +3. | During the entire study period of 6 months per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of psychiatric hospitalization | Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status. | During the entire study period of 6 months per participant | 
| Cumulated duration of psychiatric hospitalization | Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status. | During the entire study period of 6 months per participant | 
| Quality of life according to WHO Quality of Life-BREF | Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated | Baseline and 6 months | 
| Patient-evaluated depressive symptoms according to the Major Depressive Inventory | Higher scores indicate higher severity of depressive symptoms. Patient evaluated. | Baseline and 6 months | 
| Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania | Higher scores indicate higher severity of manic symptoms. Patient evaluated. | Baseline and 6 months | 
| Perceived stress according to Cohen's Perceived stress scale | Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress. | Baseline and 6 months | 
| Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder | Patient evaluated. Higher scores indicate higher satisfaction with treatment. | Baseline and 6 months | 
| Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine and the use of antidepressants | Adherence to medication will be an additional outcome measure in arms 1 and 2 of the RCT based on daily self-monitoring of medication via the Monsenso system. | During the entire study period of 6 months |