AKTIBIPO-VALIDATION: A Study to Validate Benefits of Mindpax System in Managing Bipolar Disorder

NCT ID: NCT04945057

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2023-12-31

Brief Summary

The aim of the AKTIBIPO VALIDATION study is to evaluate the effect of the Mindpax monitoring and microeducation system in patients with bipolar disorder (BD). Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study, as well as new patients (DeNovo) will be enrolled for a follow-up period of 12 months. All participants will wear the wrist actigraphy device and use the Mindpax mobile application on their mobile phone. Through the application, the patients will fill in the weekly mood self assessment questionnaire (ASERT) and receive evidence-based health microeducations aimed at understanding the bipolar disorder and associated risk factors. Apart from general psychoeducation, the participants will receive additional individualized targeted health microeducation when the system detects deviation from individual patterns of mood, activity and sleep. The outcomes will evaluate the subjective and objective impact of system usage on self-reported and clinical outcomes.

Detailed Description

Study procedure

Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study and patients with no history of using the Mindpax system (DeNovo) will be enrolled for a follow-up period of 12 months (+ 3 additional months for DeNovo patients). All participants will wear the wrist actigraphy device (Mindpax) at all times and use the Mindpax mobile application. At enrollment and study completion, the participants will sign the informed consent and undergo evaluation using the MADRS (Montgomery-Asberg depression rating scale) and YMRS (Young mania rating scale) scales.

Collected data

At baseline, i.e. at enrollment to the digital programme (M0) and every three months (M3,M6,M9,M12), the participants will fill in a series of self-assessment questionnaires: the Q-les-Q (the Quality of life Enjoyment and Satisfaction Questionnaire), HLS-CZ-12 (Health literacy survey), WHODAS 2.0 CZ (the WHO disability assessment schedule), BMQ-CZ (Beliefs about medicines questionnaire) and MARS-CZ (the Medication adherence report scale). The patients will also be evaluated using the CGI-S (Clinical global impression, M0-M12). The psychosocial and clinical events (hospitalizations, relapses), current medication and illness history will be collected throughout the study (M0-M12).

The DeNovo patients with no history of using the Mindpax application will complete additional 3 months of actigraphy and self-assessment monitoring with no intervention and limited feedback (mirror period), prior to visit M0. At entering this observational period, the same set of aforementioned instruments will be collected (visit M-3).

Study endpoints

The primary endpoint is the change in Q-les-Q score at M12, compared to M0. Secondary endpoints include: i) higher health status (lower number of hospitalization days, compared to the same amount of time in the preceding AKTIBIPO study or mirror period for DeNovo patients), ii) lower subjectively rated symptom level (compared to the same amount of time in the preceding AKTIBIPO study or mirror period), iii) higher rate of health literacy at M12, compared to M0, and iv) Higher treatment adherence and better understanding to medication at M12, compared to M0.

Microeducation

• During the study, microeducation messages will be delivered to patients via Mindpax smartphone app on a regular basis (at least once a week, maximum two messages per week).
• This approach will aim at well-being, coping with stress, increasing the regularity and stabilization of social rhythms, daily routines and therapy adherence. The main focus is to enhance role functioning in the society and workspace, and decrease the likelihood of another mood episodes among patients in a symptomatic illness stage.
• Generic microeducational messages will address a wide array of stress-coping and interpersonal problem areas such as grief for "losing" the healthy self and disagreements with others, promoting the importance of therapy adherence, addressing transitions that can affect the patient's normal routine, supplying information on managing the bipolar illness, and providing tools for relapse prevention
• Two types of alert scores will be calculated for duration of sleep and overall activity. Based on this alerting system, target microeducative messages will be consequently generated and delivered on the participant's smartphone to help patients change their maladaptive behavior by reducing current sleep/wake and daily activity irregularity and avoid behaviors that may adversely affect social rhythms.
• In a meantime, digital diary smartphone feedback will provide continuously upgraded infographics on variability of daily activities such as wake time, bed time, sleep onset, sleep regularity and inter-daily variability in those parameters.
• This circadian feedback feature will inform patients to what extent the past microeducative messages influenced their daily routines. This way, a feedback information will encourage participants to change their behavior by showing the impact that corrective behavior had on their mood. App feedback and microeducative content could help prevent recurrences by helping the subject to recognize and modify their future behaviors

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

All participants will use the Mindpax mobile application, wear the wrist accelerometer and fill in weekly self-assessments. All participants will obtain weekly health tips (general psychoeducation) and additional individualized targeted tips when the system detects deviation from individual mood, activity and sleep patterns.

Participants, who did not participate in the previous AKTIBIPO study (DeNovo) will complete additional 3 months of actigraphy and self-evaluation monitoring with research version of the Mindpax application, providing limited feedback and no health tips.

Group Type: EXPERIMENTAL

Mindpax monitoring system

Intervention Type: DEVICE

All participants will use the Mindpax mobile application, wear the wrist accelerometer and fill in weekly self-assessments. All participants will obtain weekly health tips (general psychoeducation) and additional individualized targeted tips when the system detects deviation from individual mood, activity and sleep patterns, during the active 12 months of followup.

Interventions

Mindpax monitoring system

All participants will use the Mindpax mobile application, wear the wrist accelerometer and fill in weekly self-assessments. All participants will obtain weekly health tips (general psychoeducation) and additional individualized targeted tips when the system detects deviation from individual mood, activity and sleep patterns, during the active 12 months of followup.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women with a diagnosis of bipolar disorder (BD, F31.x)
• between 18 to 65 years old.
• Participants with acceptable compliance in the past AKTIBIPO400 study: completeness of activity data and weekly mood reporting data at least 50% each.
• Newly admitted patients (DeNovo): currently treated for BD, ability to provide psychiatric hospitalization history provided from medical health record or health insurance records.

Exclusion Criteria

• Organic mental disorder
• mental disorder due to psychoactive substance use,
• current hospitalization or mood episode at admission, measured by the Montgomery-Åsberg Depression rating scale (MADRS) ≥ 19 or Young Mania Rating Scale (YMRS) ≥ 19 at admission.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mindpax s.r.o., Czech Republic

UNKNOWN

Sponsor Role: collaborator

National Institute of Mental Health, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Institute of Mental Health

Klecany, , Czechia

Countries

Czechia

Other Identifiers

AKTIBIPO-VALIDATION

Identifier Type: -

Identifier Source: org_study_id