Trial · NCT07890805
Evaluating the PolarUs App in People With Bipolar Disorder
NCT07890805, Not applicable, Not yet recruiting, University of British Columbia
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the PolarUs App in People With Bipolar Disorder. Trials, record NCT07890805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07890805
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the PolarUs App in People With Bipolar Disorder
- NCT number
- NCT07890805
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 504 participants, estimated
- Lead sponsor
- University of British Columbia
- Conditions
- Bipolar Disorder (BD), Quality of Life (QOL)
- Interventions
- PolarUs Mobile App
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brief Quality of Life in Bipolar Disorder (QoL.BD) Scale | At enrolment, followed by every 4 weeks during the 12 week study-period. | The Brief QoL.BD contains 12 items representing core life areas (Physical, Sleep, Mood, Cognition, Leisure, Social, Spirituality, Finance, Household, Self-Esteem, Independence, and Identity). Each item contains five Likert-type items to assess satisfaction with that life area (1 = Strongly Disagree to 5 = Strongly Agree). Overall scores are calculated by summing responses to the 12 items (range: 12-60), with higher scores indicating greater life satisfaction. Initial field testing showed the Brief QoL.BD had excellent internal reliability (Cronbach's α=0.88) and higher sensitivity to change in clinician-rated symptoms of depression than generic QoL measures. The QoL.BD has been used in clinical trials, with sensitivity to treatment effects and construct validity demonstrated through associations with symptoms of mania and depression, generic QoL instruments, and functioning. The scale has been validated for use in multiple languages, including French, Mandarin Chinese and Spanish. |
| Secondary | Patient Health Questionnaire 8 (PHQ-8) | At enrolment, followed by every 4 weeks during the 12 week study-period. | Self-reported depressive symptoms will be assessed by the Patient Health Questionnaire-8 (PHQ-8), which evaluates 8 of the 9 criteria for depression from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The eight Likert-type items ask about the frequency of depressive symptoms experienced in the past two weeks (0 = "Not at all" to 3 = "Nearly every day"). Responses are summed to create a total score (range: 0-24); higher scores indicate greater depression severity. The PHQ-8 performs comparably with clinician assessments; internal reliability has been demonstrated in population studies (Cronbach α=0.87). The PHQ-8 has comparable performance to the original nine item version (PHQ-9), which assesses all DSM-IV criteria, including current suicidal ideation. The PHQ-8 was chosen since formal psychiatric evaluation and supports cannot be provided through this study. Additionally, data collected is self-reported and immediate follow-up isn't possible. |
| Secondary | Internal State Scale (ISS) Version 2 | At enrolment, followed by every 4 weeks during the 12 week study-period. | The ISS consists of four subscales: Activation, Well Being, Perceived Conflict, and the Depression Index. A single-item Global Bipolar Scale is also included for reference to earlier single analog line mood scales for bipolar disorder. Scoring of every item is based on a Likert scale with eleven "bins" (equivalent to 0-10, 11- 20, …91-100), whereby the first bin is scored as zero, the second as 10, and so on to the eleventh bin which is scored as 100. The Well Being subscale used in conjunction with the Activation Subscale is used to discriminate between depressed, (hypo)manic, and subsyndromal/euthymic states: (Hypo)Mania: \>=155 on Activation and \>=125 on Wellbeing Subscales Mixed State: \>=155 on Activation and \<125 on Wellbeing Subscales Euthymia: \<155 on Activation and \>=125 on Wellbeing Subscales Depression: \<155 on Activation and \<125 on Wellbeing Subscales The Activation, Depression Index and Perceived Conflict subscales can be used as symptom severity self-report scales. |
| Secondary | WHOQOL-BREF | At enrolment, followed by every 4 weeks during the 12 week study-period. | The WHOQOL-BREF is a 26-item questionnaire assessing four domains contributing to quality of life (QoL) (physical health, psychological health, social relationships, environment). The WHOQOL-BREF is a general QoL measure. The 26-items of the WHOQOL-BREF are scored from 1-5 on a likert scale. Domain scores are calculated by taking the mean of all items included in each domain and multiplying by a factor of four. These scores are then transformed to a 0-100 scale, with a higher score indicating a higher quality of life for that domain. |
| Secondary | Self-Compassion Scale-Short Form (SCS-SF) | At enrolment, followed by every 4 weeks during the 12 week study-period. | The Self-Compassion Scale-Short Form contains 12 Likert-type items (1=Almost Never, 5 = Almost Always) used to assess 6 dimensions of self-compassion: self-kindness, self-judgement, common humanity, isolation, mindfulness, and overidentification. Subscales are calculated by averaging relevant items to calculate an overall score (range: 1-5); negative subscales are reverse-coded. Higher overall scores indicate more frequent self-compassionate behaviours and attitudes. Internal consistency has been demonstrated (Cronbach α=0.86); confirmatory factor analysis supports both the 6 subscales and a single higher-order factor of self-compassion. |
| Secondary | Self-Efficacy for Managing Chronic Disease Scale (SEMCD) | At enrolment, followed by every 4 weeks during the 12 week study-period. | The 6-item SEMCD-6 measures self-efficacy to manage chronic disease, asking patients to rate their confidence in their abilities to perform a range of self-management tasks. Each of the 6 items are rated on a scale from 1 ('not at all confident') to 10 ('totally confident'). Scores for the scale are calculated as a mean of the 6 items (minimum score = 1, maximum score = 10), with higher scores indicating greater self-efficacy. |
| Secondary | User Engagement Scale-Short Form (UES-SF) | At week 4, followed by every 4 weeks during the 12 week study-period. | The User Engagement Scale-Short Form will be used to measure self-reported user engagement. The form has 12 items and uses a 5 point Likert scale (1=Strongly disagree to 5=Strongly agree). Scores range from 1-5, with higher scores indicating more engaging material. An overall engagement score can be calculated by adding all of the items together and dividing by twelve. |
| Secondary | App Engagement Data | In real-time, after users receive access to the PolarUs app for the 12 week study-period. | Behavioural indicators of app engagement will be assessed objectively and continuously through automatically tracked usage metrics collected in real time through Google Analytics. Variables such as frequency of app use, retention, attrition, dwell time on pages, strategies chosen and resources accessed will be collected. |
| Secondary | Matryoshka Service Needs Profile (SNP) | At enrolment, followed by every 4 weeks during the 12 week study-period. | The Matryoshka Service Needs Profile, based on the Client Service Receipt Inventory, will be used to collect information about healthcare resource use (i.e., healthcare provider visits, inpatient stays, emergency department visits, and psychotropic medication consumption) and health-related quality of life. Descriptive statistics will be used to describe the characteristics of healthcare received by the study participant. The Matryoshka SNP has been successfully used in evaluations of mental health programs and social enterprises and can be adapted for different contexts. Unit prices will be based on those applicable to a Canadian or United States participant, as appropriate. |
| Secondary | EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | At enrolment, followed by every 4 weeks during the 12 week study-period. | The EQ-5D-5L will be used to collect information about health-related quality of life outcomes through a descriptive profile and visual analogue scale (VAS). The descriptive profile encompasses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with each dimension rated on a five-level scale, from no problems (level 1) to extreme problems (level 5). Ratings of the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). The VAS provides participant's rating of their health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine'). Higher scores indicate better health outcomes. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers24
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07890805
GET https://conductscience.org/api/trials/v1/NCT07890805/papers?page=2