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

Mental Health Services in the Capital Region, Denmark

Status: Enrolling

Conditions: Bipolar Disorder

Treatments: Device: The Monsenso system without feedback; Device: The Monsenso system with feedback; Device: CAG Bipola and mood monitoring only

Study type: Interventional

Funder types: Other

Identifiers

NCT04230421

H-19067259

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Monsenso with feedback

Experimental group

Description:

Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.

Treatment:

Device: The Monsenso system with feedback

Monsenso without feedback

Active Comparator group

Description:

Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback.

Treatment:

Device: The Monsenso system without feedback

Control

Active Comparator group

Description:

CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system.

Treatment:

Device: CAG Bipola and mood monitoring only