Health TrialsbyHealthPanel

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

ConditionBipolar Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • The Monsenso system with feedback

    Device

    See description under intervention

  • The Monsenso system without feedback

    Device

    See description under intervention

  • CAG Bipola and mood monitoring only

    Device

    See description under intervention

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Monsenso with feedbackExperimental treatment 1 intervention
Group B: Monsenso without feedbackActive comparator 1 intervention
Group C: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Daily self-reported mood instability via Monsenso

Mood measured daily via smartphones on a scale form -3 to +3.

Time frame
During the entire study period of 6 months per participant

Secondary outcomes

1

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.

Time frame
During the entire study period of 6 months per participant
2

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.

Time frame
During the entire study period of 6 months per participant
3

Quality of life according to WHO Quality of Life-BREF

Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated

Time frame
Baseline and 6 months
4

Patient-evaluated depressive symptoms according to the Major Depressive Inventory

Higher scores indicate higher severity of depressive symptoms. Patient evaluated.

Time frame
Baseline and 6 months

Other outcomes

1

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

Time frame
During the entire study period of 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Lead sponsor

Maria Faurholt-Jepsen, MD, DMSc

Collaborator

The Mental Health Services in the Capital Region of Denmark

Collaborator

Source ClinicalTrials.gov
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