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Not Yet Recruiting NCT07890805

Evaluating the PolarUs App in People With Bipolar Disorder

Conditions: Bipolar Disorder (BD), Quality of Life (QOL)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 504
Sponsor: University of British Columbia

Location: University of British Columbia Vancouver British Columbia

Summary

Our team recently pilot tested a new mobile app, PolarUs, co-designed with people who live with bipolar disorder (BD), to support BD self-management and quality of life (QoL) measurement. An initial study suggested the app improved QoL and mood scores over time among participants in Canada and the United States. This project aims to fully assess whether PolarUs improves QoL and mood outcomes in diverse people with BD living in Canada and the United States. To achieve this, we have (1) culturally and linguistically adapted the English version of PolarUs into French, Mandarin, and Spanish, and (2) are now conducting a randomized controlled trial (RCT) to assess whether PolarUs (in all 4 languages) improves QoL and mood outcomes in adults living with BD in Canada and the United States. Participants will: 1. Attend an eligibility assessment interview to confirm their eligibility to participate. 2. Eligible participants will be randomly assigned (like flipping a coin) to one of two groups: Group 1 - Receive access to the PolarUs app through participants' Android (Google) or iOS (Apple) mobile device for a period of 12 weeks. Group 2 - Receive access to the PolarUs app after a 12-week waiting period. During the waiting period, participants will only receive study assessments. 3. Participants will complete study assessments at the beginning and end of the 12-week period and, where appropriate, monthly during the study period. We aim to recruit approximately 480 participants from Canada and the United States to take part in the study. We would also like to understand how people with bipolar disorder use and engage with the app.

Eligibility Criteria

Inclusion Criteria (participants must meet all of the criteria below to participate): * Having a primary DSM-5 diagnosis of BD I, BD II, cyclothymic disorder, OSBD, or UBD, as assessed using the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) * Aged ≥18 years * Having no prior exposure to the PolarUs app * Having access to a smartphone capable of downloading and using the app (i.e., running Apple's iOS 13 or later, or Google's Android 10 or later operating system) * Residing in Canada or the United States * Able to speak, read, and write in English, or are bilingual in English and one of French, Chinese (Mandarin), or Spanish Exclusion Criteria: \- Experiencing current symptoms of psychosis and/or those with active suicidal ideation as assessed by the DIAMOND diagnostic interview

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07890805). StuddyBuddy aggregates publicly available trial information.