Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

June 24, 2020 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals diagnosed with bipolar disorder
  • Individuals with a smart-phone

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No weekly review
Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
Other: No weekly review
An interviewer will not review self-report symptoms and patterns collected from an activity tracker.
Other Names:
  • Placebo
Experimental: Weekly review
Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms
Time Frame: 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.
Study end (6 weeks)
Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions
Time Frame: 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).
Study end (6 weeks)
Average Proportion of Study Days With At Least 12 Hours of Activity Tracking
Time Frame: 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)
Study end (6 weeks)
Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking
Time Frame: 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.
Study end (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale
Time Frame: 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.
Baseline, study end (6 weeks)
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
Time Frame: 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.
Baseline, study end (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute of Mental Health (NIMH)
University of Michigan

Investigators

  • Principal Investigator: Amy L Cochran, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Actual)

June 19, 2019

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

November 26, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K01MH112876 (U.S. NIH Grant/Contract)
  • HUM00126732 (Other Identifier: University of Michigan)
  • 2017-1322 (Other Identifier: University of Wisconsin)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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