Clinical trial NCT04230421: Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar
Official title: Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Maria Faurholt-Jepsen, MD, DMSc
name: The Mental Health Services in the Capital Region of Denmark
First posted: 2020-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

* None

Primary outcomes:
measure: Daily self-reported mood instability via Monsenso
timeFrame: During the entire study period of 6 months per participant
Secondary outcomes:
measure: Risk of psychiatric hospitalization
timeFrame: During the entire study period of 6 months per participant
measure: Cumulated duration of psychiatric hospitalization
timeFrame: During the entire study period of 6 months per participant
measure: Quality of life according to WHO Quality of Life-BREF
timeFrame: Baseline and 6 months
measure: Patient-evaluated depressive symptoms according to the Major Depressive Inventory
timeFrame: Baseline and 6 months
measure: Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania
timeFrame: Baseline and 6 months
measure: Perceived stress according to Cohen's Perceived stress scale
timeFrame: Baseline and 6 months
measure: Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
timeFrame: Baseline and 6 months
measure: 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
timeFrame: During the entire study period of 6 months
Other outcomes:
measure: Patient-reported smartphone-based symptoms
timeFrame: During the entire study period of 6 months
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen, Rigshospitalet
Study officials:
References: