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Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

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ClinicalTrials.gov Identifier: NCT03358238
Recruitment Status : Enrolling by invitation
First Posted : November 30, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
University of Michigan
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Weekly review Other: No weekly review Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Modeling Mood Course to Detect Markers of Effective Adaptive Interventions
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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 Name: 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.




Primary Outcome Measures :
  1. 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.

  2. Difference in adherence rates for self-reporting symptoms between 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) [ Time Frame: Study end (6 weeks) ]
    For each individual, 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.

  3. Difference in adherence rates for activity tracking between 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) [ 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.

  4. 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.


Secondary Outcome Measures :
  1. 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 11 items to evaluate symptoms of mania, such as elevated mood, energy, and irritability. Item scores are added together to get a total score.

  2. 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 items to evaluate symptoms of depression, such as guilt, fatigue, depressed mood. Item scores are summed to get a total score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358238


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Amy L Cochran, PhD University of Wisconsin, Madison

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03358238     History of Changes
Other Study ID Numbers: K01MH112876 ( U.S. NIH Grant/Contract )
K01MH112876 ( U.S. NIH Grant/Contract )
HUM00126732 ( Other Identifier: University of Michigan )
2017-1322 ( Other Identifier: University of Wisconsin )
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders