Bipolar Disorder
Conditions
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.
Interventions
DEVICEThe Monsenso system with feedback
See description under intervention
DEVICEThe Monsenso system without feedback
See description under intervention
DEVICECAG Bipola and mood monitoring only
See description under intervention
Sponsors
Maria Faurholt-Jepsen, MD, DMSc
The Mental Health Services in the Capital Region of Denmark
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported smartphone-based symptoms | During the entire study period of 6 months | Patietns-reported smartphone-based symptoms such as stress, anxiety, activity, sleep, mixed mood, adherence to medication and adherence to patient-reported smartphone-based monitoring |
Countries
Denmark
Contacts
Primary ContactLars Vedel Kessing, Prof., MD, DMSc
Backup ContactMaria Faurholt-Jepsen, MD, DMSc
Outcome results
None listed