Bipolar DisorderNCT04230421
Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar
A study testing The Monsenso system with feedback, The Monsenso system without feedback and CAG Bipola and mood monitoring only in people with Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- The Monsenso system with feedback, The Monsenso system without feedback and CAG Bipola and mood monitoring only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Psychiatric Center Copenhagen, Rigshospitalet
Copenhagen, 2100
Maria Faurholt-Jepsen
Lars Vedel Kessing
About this study
Official title: Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT
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).
Read the 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
- Being tested
- The Monsenso system with feedback, The Monsenso system without feedback, CAG Bipola and mood monitoring only
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Monsenso system with feedbackDevice
See description under intervention
The Monsenso system without feedbackDevice
See description under intervention
CAG Bipola and mood monitoring onlyDevice
See description under intervention
| Study group | Role | What they receive |
|---|---|---|
| Monsenso with feedback | Experimental | Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback. Receives: Device: The Monsenso system with feedback |
| Monsenso without feedback | Active comparator | Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback. Receives: Device: The Monsenso system without feedback |
| Control | Active comparator | CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system. Receives: Device: CAG Bipola and mood monitoring only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily self-reported mood instability via Monsenso
Mood measured daily via smartphones on a scale form -3 to +3.
Measured: During the entire study period of 6 months per participant
Secondary outcomes (8)
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.
Measured: During the entire study period of 6 months per participant
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.
Measured: During the entire study period of 6 months per participant
Quality of life according to WHO Quality of Life-BREF
Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated
Measured: Baseline and 6 months
Patient-evaluated depressive symptoms according to the Major Depressive Inventory
Higher scores indicate higher severity of depressive symptoms. Patient evaluated.
Measured: Baseline and 6 months
Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania
Higher scores indicate higher severity of manic symptoms. Patient evaluated.
Measured: Baseline and 6 months
Perceived stress according to Cohen's Perceived stress scale
Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.
Measured: Baseline and 6 months
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Patient evaluated. Higher scores indicate higher satisfaction with treatment.
Measured: Baseline and 6 months
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.
Measured: During the entire study period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Mar 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark
- Responsible party
- Principal investigator, Lars Vedel Kessing, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230421
- Sponsor's protocol ID
- H-19067259
- Status last verified
- Jun 2023
- First submitted
- 3 Jan 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faurholt-Jepsen M, Risom A, Dyreholt MS, Kyster NB, Christensen EM, Smidt B, Knorr U, Brondmark K, Mathiesen A, Cululejevic D, Sjaelland R, Norbak-Emig H, Sponsor LL, Mardosas D, Bukh JD, Heller TV, Iversen N, Vinberg M, Budtz-Jorgensen E, Kessing LV. The effect of smartphone-based monitoring and treatment including clinical feedback in progressed bipolar disorder: the SmartBipolar trial randomised controlled parallel-group trial. Int J Bipolar Disord. 2026 Mar 22;14(1):17. doi: 10.1186/s40345-026-00418-w.
PubMed 41865316Swieczkowski D, Kwasny A, Cubala WJ. Cross-sectional analysis of ongoing clinical trials involving lamotrigine for mental disorders: Insights from ClinicalTrials.gov and the EU clinical trials. Psychiatry Res. 2026 Feb;356:116878. doi: 10.1016/j.psychres.2025.116878. Epub 2025 Dec 4.
PubMed 41401709Faurholt-Jepsen M, Kyster NB, Dyreholt MS, Christensen EM, Bondo-Kozuch P, Lerche AS, Smidt B, Knorr U, Brondmark K, Cardoso AB, Mathiesen A, Sjaelland R, Norbak-Emig H, Sponsor LL, Mardosas D, Sarauw-Nielsen IP, Bukh JD, Heller TV, Frost M, Iversen N, Bardram JE, Busk J, Vinberg M, Kessing LV. The effect of smartphone-based monitoring and treatment including clinical feedback versus smartphone-based monitoring without clinical feedback in bipolar disorder: the SmartBipolar trial-a study protocol for a randomized controlled parallel-group trial. Trials. 2023 Sep 12;24(1):583. doi: 10.1186/s13063-023-07625-1.
PubMed 37700334
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT
- ClinicalTrials.gov ID
- NCT04230421
- Acronym / sponsor ID
- H-19067259
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monsenso with feedback | Experimental | Device: The Monsenso system with feedbackDaily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback. |
| Monsenso without feedback | Active comparator | Device: The Monsenso system without feedbackDaily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback. |
| Control | Active comparator | Device: CAG Bipola and mood monitoring onlyCAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Monsenso system with feedbackSee description under intervention | Device | Monsenso with feedback |
| The Monsenso system without feedbackSee description under intervention | Device | Monsenso without feedback |
| CAG Bipola and mood monitoring onlySee description under intervention | Device | Control |
Primary outcome
Daily self-reported mood instability via Monsenso
Time frame: During the entire study period of 6 months per participant
Mood measured daily via smartphones on a scale form -3 to +3.
8 secondary outcomes
Risk of psychiatric hospitalization
Time frame: During the entire study period of 6 months per participant
Cumulated duration of psychiatric hospitalization
Time frame: During the entire study period of 6 months per participant
Quality of life according to WHO Quality of Life-BREF
Time frame: Baseline and 6 months
Patient-evaluated depressive symptoms according to the Major Depressive Inventory
Time frame: Baseline and 6 months
Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania
Time frame: Baseline and 6 months
Perceived stress according to Cohen's Perceived stress scale
Time frame: Baseline and 6 months
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Time frame: Baseline and 6 months
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
Time frame: During the entire study period of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 41865316Faurholt-Jepsen M, Risom A, Dyreholt MS, Kyster NB, Christensen EM, Smidt B, Knorr U, Brondmark K, Mathiesen A, Cululejevic D, Sjaelland R, Norbak-Emig H, Sponsor LL, Mardosas D, Bukh JD, Heller TV, Iversen N, Vinberg M, Budtz-Jorgensen E, Kessing LV. The effect of smartphone-based monitoring and treatment including clinical feedback in progressed bipolar disorder: the SmartBipolar trial randomised controlled parallel-group trial. Int J Bipolar Disord. 2026 Mar 22;14(1):17. doi: 10.1186/s40345-026-00418-w.
- Derived from this study: PubMed 41401709Swieczkowski D, Kwasny A, Cubala WJ. Cross-sectional analysis of ongoing clinical trials involving lamotrigine for mental disorders: Insights from ClinicalTrials.gov and the EU clinical trials. Psychiatry Res. 2026 Feb;356:116878. doi: 10.1016/j.psychres.2025.116878. Epub 2025 Dec 4.
- Derived from this study: PubMed 37700334Faurholt-Jepsen M, Kyster NB, Dyreholt MS, Christensen EM, Bondo-Kozuch P, Lerche AS, Smidt B, Knorr U, Brondmark K, Cardoso AB, Mathiesen A, Sjaelland R, Norbak-Emig H, Sponsor LL, Mardosas D, Sarauw-Nielsen IP, Bukh JD, Heller TV, Frost M, Iversen N, Bardram JE, Busk J, Vinberg M, Kessing LV. The effect of smartphone-based monitoring and treatment including clinical feedback versus smartphone-based monitoring without clinical feedback in bipolar disorder: the SmartBipolar trial-a study protocol for a randomized controlled parallel-group trial. Trials. 2023 Sep 12;24(1):583. doi: 10.1186/s13063-023-07625-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Monsenso system with feedback, The Monsenso system without feedback and CAG Bipola and mood monitoring only in people with Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Vedel Kessing, Prof., MD, DMSc (+4538647073, lars.vedel.kessing@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily self-reported mood instability via Monsenso (time frame: During the entire study period of 6 months per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230421, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.