NCT03358238

Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

Completed NA Results posted Last updated 9 July 2020

What this trial tests

NA trial testing Weekly review in Bipolar Disorder in 50 participants. Completed in 19 June 2019.

Timeline

27 November 2017

Primary endpoint
19 June 2019

19 June 2019

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	50
Start date	27 November 2017
Primary completion	19 June 2019
Estimated completion	19 June 2019
Sites	2 locations across United States

Drugs / interventions tested

• Weekly review
• No weekly review

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms Primary · Study end (6 weeks)

Likelihood of using app over activity tracker is measured using a survey designed specifically for this study to evaluate participant engagement in monitoring symptoms. The relevant question asks 'Which are you more likely to use to monitor your symptoms' and has two mutually-exclusive options for an answer: 'An activity tracker' or 'A smart-phone app'. Engagement survey is conducted over the phone by an interviewer.

Group	Value	95% CI
All Participants	0.404	0.264 – 0.557

Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions Primary · Study end (6 weeks)

For each individual, adherence rate for self-reporting symptoms is measured/defined as the proportion of study days with at least 50% completion of of daily self-reports questions (i.e. 6 questions completed out of a total of 12). This measure is the average adherence rate for individuals in each of the two intervention arms: individuals who review their data with an interviewer ('Weekly review' arm) vs those who do not review their data with an interviewer ('No weekly review' arm).

Group	Value	95% CI
Review Arm	0.8185	0.6954 – 0.9415
No Review Arm	0.8168	0.6865 – 0.9470

Average Proportion of Study Days With At Least 12 Hours of Activity Tracking Primary · Study end (6 weeks)

For each individual, adherence rate for activity tracking is measured as the proportion of study days with at least 12 hours of activity tracking. This measure is the average adherence rates among individuals in either arm: individuals who review their data weekly with an interviewer ('Weekly review' arm) compared to individuals who do not review their data weekly with an interviewer ('No weekly review' arm)

Group	Value	95% CI
Review Arm	0.7688	0.6323 – 0.9054
No Review Arm	0.7878	0.6376 – 0.9379

Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking Primary · Study end (6 weeks)

For each individual, adherence rate for activity tracking is measured as the proportion of study days with at least 12 hours of activity tracking, whereas adherence rate for self-reporting symptoms is measured as the proportion of study days with at least 50% of daily self-reports survey questions completed.

Group	Value	95% CI
Review Arm Participants With Unequal Adherence	0.6667	0.4303 – 0.8541
No Review Arm Participants With Unequal Adherence	0.3889	0.1730 – 0.6425

Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale Secondary · Baseline, study end (6 weeks)

The Young Mania Rating Scale consists of clinician-rated 11 items to evaluate symptoms of mania, such as elevated mood, energy, and irritability. Item scores are added together to get a total score, ranging from 0 to 60. A higher score indicates more severe manic symptoms.

Group	Value	95% CI
Review Arm	0.67	-0.54 – 1.88
No Review Arm	0.91	-1.32 – 3.15

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 Secondary · Baseline, study end (6 weeks)

The 17-Item Structured Interview Guide for the Hamilton Rating Scale for Depression consists of 17 clinician-rated items to evaluate symptoms of depression, such as guilt, fatigue, and depressed mood. Item scores are summed to get a total score, ranging from 0 to 52. Higher scores indicate more severe symptoms.

Group	Value	95% CI
Review Arm	0.67	-2.07 – 3.40
No Review Arm	1.13	-1.43 – 3.69

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over a period of six weeks for each individual participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

No Weekly Review

Serious: 0/23 (0%)

Deaths: 0/23

Weekly Review

Serious: 1/24 (4%)

Deaths: 0/24

Serious adverse events (1 terms)

Reaction	System	No Weekly Review	Weekly Review
Hospitalization	Psychiatric disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	No Weekly Review	Weekly Review
Fitbit Band Issue	Product Issues	—	—
Participant Discontinuation	Product Issues	—	—
Missed Interviews	Social circumstances	—	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT03358238 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A comparative study of engagement in mobile and wearable health monitoring for bipolar disorder.
   Van Til K, McInnis MG, Cochran A. · · 2020 · cited 29× · PMID 31610074 · DOI 10.1111/bdi.12849
2. Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial.
   Cochran A, Belman-Wells L, McInnis M. · · 2018 · cited 9× · PMID 29748160 · DOI 10.2196/resprot.9899