N/A Completed N=48 Randomized Health Services Research

Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

Source: ClinicalTrials.gov NCT03358238 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Jul 2020

Primary outcomePrimary: 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

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.

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

Eligibility Criteria

Inclusion Criteria

Individuals diagnosed with bipolar disorder
Individuals with a smart-phone

Exclusion Criteria

None

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.