Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- Mental Health Services in the Capital Region, Denmark
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Daily self-reported mood instability via Monsenso
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Lars Vedel Kessing
Prof., Principal Investigator
Mental Health Services in the Capital Region, Denmark
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Daily self-reported mood instability via Monsenso
Time Frame: During the entire study period of 6 months per participant
Mood measured daily via smartphones on a scale form -3 to +3.
Secondary Outcomes
- Risk of psychiatric hospitalization(During the entire study period of 6 months per participant)
- Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania(Baseline and 6 months)
- Perceived stress according to Cohen's Perceived stress scale(Baseline and 6 months)
- Cumulated duration of psychiatric hospitalization(During the entire study period of 6 months per participant)
- Quality of life according to WHO Quality of Life-BREF(Baseline and 6 months)
- Patient-evaluated depressive symptoms according to the Major Depressive Inventory(Baseline and 6 months)
- Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder(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(During the entire study period of 6 months)