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

NCT03033420 | Completed

• 1 other identifier: RADMIS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Affective Disorders; Unipolar Depression; Bipolar Disorder

Keywords

Unipolar disorder; Bipolar disorder; Randomized controlled trial; Smartphone; Re-admission; CBT

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months trial period

• Duration of re-admissions

  Differences in the duration of re-admissions between the intervention group and the control group.

  6 months trial period

Secondary Outcomes (4)

• Severity of depressive symptoms

  6 months trial period

• Severity of manic symptoms

  6 months trial period

• Psychosocial functioning

  6 months trial period

• Number of affective episodes

  6 months trial period

Other Outcomes (12)

• Perceived stress

  6 months trial period

• Quality of life

  6 months trial period

• Self-rated manic symptoms

  6 months trial period

Study Arms (2)

Intervention group

EXPERIMENTAL

A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules

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

Interventions

A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules DEVICE

A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules

Also known as: Monsenso

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy
• A lack of Danish language skills

Sponsors & Collaborators

• Psychiatric Centre Rigshospitalet: lead
• Technical University of Denmark: collaborator

Study Sites (1)

Psychiatric Center Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 39617464 DERIVED

• Faurholt-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.

  PMID: 28619114 DERIVED

MeSH Terms

Conditions

Mood Disorders; Depressive Disorder; Bipolar Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Bipolar and Related Disorders

Study Officials

• Maria Faurholt-Jepsen, MD

  Psychiatric Center Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 26, 2017
• Study Start: May 15, 2017
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2021
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)