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

Description

Study procedure

Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study will be enrolled for a follow-up period of 12 months. 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 (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).

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), ii) lower subjectively rated symptom level (compared to the same amount of time in the preceding AKTIBIPO study), 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

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