NCT04230421

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DEVICE	The Monsenso system with feedback	See description under intervention
DEVICE	The Monsenso system without feedback	See description under intervention
DEVICE	CAG Bipola and mood monitoring only	See description under intervention

Timeline

• Start date: 2021-03-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2020-01-18
• Last updated: 2023-06-07

Locations

1 site across 1 country: Denmark