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 (RADMIS)

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).

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Unipolar Depression; Affective Disorders
• Intervention / Treatment: Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Psychiatric Center Copenhagen, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Pregnancy
• A lack of Danish language skills

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules; Other Names: Monsenso
No Intervention: Control group; Treatment-as-usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of depressive symptoms	Differences in the severity of depressive (The Hamilton Depression Rating Scale) symptoms between the intervention group and the control group.	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.	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.	6 months trial period
Number of affective episodes	Differences in the number of affective episodes between the intervention group and the control group.	6 months trial period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	Differences in perceived stress (The Cohen's Perceived stress scale) between the intervention group and the control group.	6 months trial period
Quality of life	Differences in quality of life (The WHO Quality of Life-BREF) between the intervention group and the control group.	6 months trial period
Self-rated manic symptoms	Differences in self-rated manic symptoms (The Altman Self Rating scale for Mania) between the intervention group and the control group.	6 months trial period
Self-rated depressive symptoms	Differences in self-rated depressive symptoms (The Becks Depressive Inventory) between the intervention group and the control group.	6 months trial period
Self-rated depressive symptoms	Differences in self-rated depressive symptoms (The Hamilton Depression Self-rating Scale 6-item) between the intervention group and the control group.	6 months trial period
Recovery	Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group.	6 months trial period
Empowerment	Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group.	6 months trial period
Adherence to medication	Differences in adherence to medication (The Medicine Adherence Rating Scale) between the intervention group and the control group.	6 months trial period
Well-being	Differences in well-being according (The WHO (five) well-being index) between the intervention group and the control group.	6 months trial period
Rumination	Differences in rumination (The Rumination Response Scale) between the intervention group and the control group.	6 months trial period
Worrying	Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group.	6 months trial period
Satisfaction	Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group.	6 months trial period

Collaborators and Investigators

• Sponsor: Psychiatric Centre Rigshospitalet
• Collaborators: Technical University of Denmark
• Investigators: Principal Investigator: Maria Faurholt-Jepsen, MD, Psychiatric Center Copenhagen, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Smartphone; CBT; Bipolar disorder; Unipolar disorder; Re-admission
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Depressive Disorder; Disease; Bipolar Disorder; Mood Disorders
• Other Study ID Numbers: RADMIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No