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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230421
• Other study ID #: H-19067259
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Lars Vedel Kessing, Prof., MD, DMSc
• Phone: +4538647073
• Email: lars.vedel.kessing[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Device:
• The Monsenso system with feedback
See description under intervention
• The Monsenso system without feedback
See description under intervention
• CAG Bipola and mood monitoring only
See description under intervention

Locations

Country	Name	City	State
Denmark	Psychiatric Center Copenhagen, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-reported smartphone-based symptoms	Patietns-reported smartphone-based symptoms such as stress, anxiety, activity, sleep, mixed mood, adherence to medication and adherence to patient-reported smartphone-based monitoring	During the entire study period of 6 months
Primary	Daily self-reported mood instability via Monsenso	Mood measured daily via smartphones on a scale form -3 to +3.	During the entire study period of 6 months per participant
Secondary	Risk of psychiatric hospitalization	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.	During the entire study period of 6 months per participant
Secondary	Cumulated duration of psychiatric hospitalization	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.	During the entire study period of 6 months per participant
Secondary	Quality of life according to WHO Quality of Life-BREF	Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated	Baseline and 6 months
Secondary	Patient-evaluated depressive symptoms according to the Major Depressive Inventory	Higher scores indicate higher severity of depressive symptoms. Patient evaluated.	Baseline and 6 months
Secondary	Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania	Higher scores indicate higher severity of manic symptoms. Patient evaluated.	Baseline and 6 months
Secondary	Perceived stress according to Cohen's Perceived stress scale	Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.	Baseline and 6 months
Secondary	Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder	Patient evaluated. Higher scores indicate higher satisfaction with treatment.	Baseline and 6 months
Secondary	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	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.	During the entire study period of 6 months