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| Name | Class |
|---|---|
| Maria Faurholt-Jepsen, MD, DMSc | UNKNOWN |
| The Mental Health Services in the Capital Region of Denmark | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monsenso with feedback | Experimental | Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback. |
|
| Monsenso without feedback | Active Comparator | Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback. |
|
| Control | Active Comparator | CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Monsenso system with feedback | Device | See description under intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Vedel Kessing, Prof., MD, DMSc | Contact | +4538647073 | lars.vedel.kessing@regionh.dk | |
| Maria Faurholt-Jepsen, MD, DMSc | Contact | +4538647073 | maria.faurholtjepsen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Center Copenhagen, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41865316 | Derived | 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. | |
| 37700334 |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| The Monsenso system without feedback |
| Device |
See description under intervention |
|
| CAG Bipola and mood monitoring only | Device | See description under intervention |
|
| 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 |
| 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 |
| Patient-evaluated depressive symptoms according to the Major Depressive Inventory | Higher scores indicate higher severity of depressive symptoms. Patient evaluated. | 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. | 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. | 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. | 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. | During the entire study period of 6 months |
| Derived |
| Faurholt-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. |