An interventional study of The Monsenso system with feedback and The Monsenso system without feedback in Bipolar Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Mental Health Services in the Capital Region, Denmark · Not applicable, Interventional, and Treatment
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).
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's planned enrollment of 200 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.
Device: The Monsenso system with feedback
Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback.
Device: The Monsenso system without feedback
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
See description under intervention
See description under intervention
See description under intervention
Daily self-reported mood instability via Monsenso
Mood measured daily via smartphones on a scale form -3 to +3.
Time frame: During the entire study period of 6 months per participant
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.
Time frame: 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.
Time frame: 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
Time frame: Baseline and 6 months
Patient-evaluated depressive symptoms according to the Major Depressive Inventory
Higher scores indicate higher severity of depressive symptoms. Patient evaluated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the entire study period of 6 months
Patient-reported smartphone-based symptoms
Patietns-reported smartphone-based symptoms such as stress, anxiety, activity, sleep, mixed mood, adherence to medication and adherence to patient-reported smartphone-based monitoring
Time frame: During the entire study period of 6 months
Plan to share: No
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Mental Health Services in the Capital Region, Denmark