Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

Bipolar Disorder Clinical Trial

Official title:

Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358238
• Other study ID #: K01MH112876
• Secondary ID: K01MH112876HUM00
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: June 19, 2019

Study information

• Verified date: June 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Bipolar disorder is a chronic illness of profound shifts in mood ranging from mania to depression. Bipolar disorder is successfully treated by combining medication with psychosocial therapy, but care can prove inadequate in practice. With gaps in coverage and medication, along with imprecise guidelines on when, where, and how to intervene, promising psychosocial therapies require adaptive strategies to better address the specific needs of individuals in a timely manner. To accomplish this, however, requires evidence-based practices for adapting a psychosocial therapy. The long-term goal of this study is to address this knowledge gap, by establishing a mobile health platform for translating a psychosocial therapy in bipolar disorder into an effective adaptive intervention.

An important first step and the specific goal of this study is to answer the question of how to engage individuals with bipolar disorder in long-term monitoring of their daily patterns of mood, stress, sleep, circadian rhythm, and medical adherence. To answer this question, individuals with bipolar disorder will interact with a smart-phone application and activity tracker over six weeks. Individuals will record their symptoms twice-daily with the smart-phone application while activity, sleep, and heart rate are recorded with their activity tracker. In addition, individuals will be interviewed on a weekly basis. The study focuses on testing three engagement strategies: using activity trackers rather than self-reports; reviewing recorded symptoms with another person on a weekly basis; and synthesizing a person's data into charts and graphs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals diagnosed with bipolar disorder

• Individuals with a smart-phone

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Weekly review
Each week in the study, an interviewer will review manic and depressive symptoms self-reported by a participant and patterns of activity, sleep, and heart rate collected by the participant's activity tracker.

Other:
• No weekly review
An interviewer will not review self-report symptoms and patterns collected from an activity tracker.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Mental Health (NIMH), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms	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.	Study end (6 weeks)
Primary	Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions	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).	Study end (6 weeks)
Primary	Average Proportion of Study Days With At Least 12 Hours of Activity Tracking	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)	Study end (6 weeks)
Primary	Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking	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.	Study end (6 weeks)
Secondary	Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale	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.	Baseline, study end (6 weeks)
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	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.	Baseline, study end (6 weeks)