Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar
- Conditions
- Bipolar Disorder
- Interventions
- Device: The Monsenso system without feedbackDevice: CAG Bipola and mood monitoring onlyDevice: The Monsenso system with feedback
- Registration Number
- NCT04230421
- Lead Sponsor
- Mental Health Services in the Capital Region, Denmark
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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)
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monsenso without feedback The Monsenso system without feedback Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback. Control CAG Bipola and mood monitoring only CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system. Monsenso with feedback The Monsenso system with feedback Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.
- Primary Outcome Measures
Name Time Method Daily self-reported mood instability via Monsenso During the entire study period of 6 months per participant Mood measured daily via smartphones on a scale form -3 to +3.
- Secondary Outcome Measures
Name Time Method Risk of psychiatric hospitalization During the entire study period of 6 months per participant 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.
Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania Baseline and 6 months Higher scores indicate higher severity of manic symptoms. Patient evaluated.
Perceived stress according to Cohen's Perceived stress scale Baseline and 6 months Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.
Cumulated duration of psychiatric hospitalization During the entire study period of 6 months per participant 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.
Quality of life according to WHO Quality of Life-BREF Baseline and 6 months Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated
Patient-evaluated depressive symptoms according to the Major Depressive Inventory Baseline and 6 months Higher scores indicate higher severity of depressive symptoms. Patient evaluated.
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder Baseline and 6 months Patient evaluated. Higher scores indicate higher satisfaction with treatment.
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 During the entire study period of 6 months 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.
Trial Locations
- Locations (1)
Psychiatric Center Copenhagen, Rigshospitalet
🇩🇰Copenhagen, Denmark