Affective DisordersRADMISNCT03033420
Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials
A study testing A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules in people with Affective Disorders and Unipolar Depression, run by Psychiatric Centre Rigshospitalet at 1 site in Denmark.
Trial summary
Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization is a major burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Affective Disorders, Unipolar Depression, Bipolar Disorder
- What is being tested?
- A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
- 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
- 15 May 2017to 1 May 2021
- 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
- Unipolar disorder or bipolar disorder diagnoses according to ICD-10
- Patients who are discharged from a psychiatric hospital in The Capital Region of Denmark following an affective episode (depression or mania)
Who cannot join
- Pregnancy
- A lack of Danish language skills
Trial locations and contacts
1 site in 1 country.
About this study
Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization is a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania.
The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region of Denmark are invited to participate. Patients are at discharge from the psychiatric hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial consists of two separate trials according to diagnosis, bipolar disorder or unipolar disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).
Read the detailed description
Background Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania. No prior trial has investigated whether the use of a smartphone-based system can prevent re-admission among patients discharged from hospital.
Methods The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar disorder and patients with bipolar disorder are invited to participate in each their trial when discharged from psychiatric hospitals in The Capital Region of Denmark following an affective episode and randomized to either 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) standard treatment (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).
Analysis Recruitment is ongoing.
Discussion If the smartphone-based monitoring system is proved effective in reducing the rate and duration of re-admissions there will be basis for using a system of this kind in the treatment of unipolar and bipolar disorder in general and in a larger scale.
- Conditions
- Affective Disorders, Unipolar Depression, Bipolar Disorder
- Being tested
- A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
- Keywords
- Unipolar disorder, Bipolar disorder, Randomized controlled trial, Smartphone, Re-admission, CBT
- Medical subject headings
- Mood Disorders, Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modulesDevice
Also called Monsenso
A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules Receives: Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules |
| Control group | No intervention | Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of re-admissions
Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers.
Measured: 6 months trial period
Duration of re-admissions
Differences in the duration of re-admissions between the intervention group and the control group.
Measured: 6 months trial period
Secondary outcomes (4)
Severity of depressive symptoms
Differences in the severity of depressive (The Hamilton Depression Rating Scale) symptoms between the intervention group and the control group.
Measured: 6 months trial period
Severity of manic symptoms
Differences in the severity of manic (The Young Mania Rating Scale) symptoms between the intervention group and the control group.
Measured: 6 months trial period
Psychosocial functioning
Differences in psychosocial functioning (The Psychosocial Functioning Assessment Short Test - FAST) between the intervention group and the control group.
Measured: 6 months trial period
Number of affective episodes
Differences in the number of affective episodes between the intervention group and the control group.
Measured: 6 months trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start15 May 2017
- Primary completion1 Mar 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Affective DisordersStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Centre Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Principal investigator, Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet
- Investigators
- Maria Faurholt-Jepsen, MD, Principal investigator, Psychiatric Center Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033420
- Sponsor's protocol ID
- RADMIS
- Acronym
- RADMIS
- Status last verified
- Sep 2022
- First submitted
- 13 Jan 2017
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faurholt-Jepsen M, Busk J, Tonning ML, Rohani D, Bardram JE, Kessing LV. Mood, Activity, and Instability in Bipolar Disorder and Unipolar Disorder-An Exploratory Post Hoc Study Using Digital Data. Acta Psychiatr Scand. 2025 Mar;151(3):426-433. doi: 10.1111/acps.13771. Epub 2024 Dec 1.
PubMed 39617464Faurholt-Jepsen M, Frost M, Martiny K, Tuxen N, Rosenberg N, Busk J, Winther O, Bardram JE, Kessing LV. Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment - the RADMIS trials: study protocol for two randomized controlled trials. Trials. 2017 Jun 15;18(1):277. doi: 10.1186/s13063-017-2015-3.
PubMed 28619114
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials
- ClinicalTrials.gov ID
- NCT03033420
- Acronym / sponsor ID
- RADMIS / RADMIS
- Conditions
- Affective Disorders, Unipolar Depression, Bipolar Disorder
- Keywords
- Unipolar disorder, Bipolar disorder, Randomized controlled trial, Smartphone, Re-admission, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Psychiatric Centre RigshospitaletUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization is a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania.
The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region of Denmark are invited to participate. Patients are at discharge from the psychiatric hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial consists of two separate trials according to diagnosis, bipolar disorder or unipolar disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).
Detailed description
Background Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania. No prior trial has investigated whether the use of a smartphone-based system can prevent re-admission among patients discharged from hospital.
Methods The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar disorder and patients with bipolar disorder are invited to participate in each their trial when discharged from psychiatric hospitals in The Capital Region of Denmark following an affective episode and randomized to either 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) standard treatment (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).
Analysis Recruitment is ongoing.
Discussion If the smartphone-based monitoring system is proved effective in reducing the rate and duration of re-admissions there will be basis for using a system of this kind in the treatment of unipolar and bipolar disorder in general and in a larger scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modulesA smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules |
| Control group | No intervention | –Treatment-as-usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unipolar disorder or bipolar disorder diagnoses according to ICD-10
- Patients who are discharged from a psychiatric hospital in The Capital Region of Denmark following an affective episode (depression or mania)
Key exclusion criteria (2 listed)
- Pregnancy
- A lack of Danish language skills
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 |
|---|---|---|
| A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modulesAlso: MonsensoA smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules | Device | Intervention group |
Primary outcome
Number of re-admissions
Time frame: 6 months trial period
Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers.
Duration of re-admissions
Time frame: 6 months trial period
Differences in the duration of re-admissions between the intervention group and the control group.
4 secondary outcomes
Severity of depressive symptoms
Time frame: 6 months trial period
Severity of manic symptoms
Time frame: 6 months trial period
Psychosocial functioning
Time frame: 6 months trial period
Number of affective episodes
Time frame: 6 months trial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Derived from this study: PubMed 39617464Faurholt-Jepsen M, Busk J, Tonning ML, Rohani D, Bardram JE, Kessing LV. Mood, Activity, and Instability in Bipolar Disorder and Unipolar Disorder-An Exploratory Post Hoc Study Using Digital Data. Acta Psychiatr Scand. 2025 Mar;151(3):426-433. doi: 10.1111/acps.13771. Epub 2024 Dec 1.
- Derived from this study: PubMed 28619114Faurholt-Jepsen M, Frost M, Martiny K, Tuxen N, Rosenberg N, Busk J, Winther O, Bardram JE, Kessing LV. Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment - the RADMIS trials: study protocol for two randomized controlled trials. Trials. 2017 Jun 15;18(1):277. doi: 10.1186/s13063-017-2015-3.
- 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.
Maria Faurholt-Jepsen, MD principal investigator
Psychiatric Center Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules in people with Affective Disorders and Unipolar Depression, run by Psychiatric Centre Rigshospitalet 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of re-admissions (time frame: 6 months trial period). The study lists 2 primary outcomes in all. 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 NCT03033420, which also lists 2 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 29 Sep 2022.