N/A
N=48
Modeling Mood Course to Detect Markers of Effective Adaptive Interventions
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03358238 ↗Enrolled (actual)
48
Serious AEs
2.1%
Results posted
Jul 2020
Primary outcome: Primary: Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms — 0.404 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Weekly review (Behavioral); No weekly review (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms |
0.404 | — |
| PRIMARY Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions |
0.8185; 0.8168 | 0.99 |
| PRIMARY Average Proportion of Study Days With At Least 12 Hours of Activity Tracking |
0.7688; 0.7878 | 0.85 |
| PRIMARY Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking |
0.6667; 0.3889 | 0.0828 |
| SECONDARY Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale |
0.67; 0.91 | 0.20 |
| SECONDARY Average Change From Baseline in Severity of Depressive Symptoms, as Measured With the 17-item Structured Interview Guide for the Hamilton Rating Scale for Depression |
0.67; 1.13 | 0.32 |
Summary
The goal of this study is to learn how to engage individuals with bipolar disorder in long-term monitoring of daily patterns of mood, stress, sleep, circadian rhythm, and medical adherence. Knowledge gained will be used to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder into an effective adaptive intervention.
Eligibility Criteria
Inclusion Criteria
- Individuals diagnosed with bipolar disorder
- Individuals with a smart-phone
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT03358238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.