Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

University of Wisconsin (UW)

Status: Completed

Conditions: Bipolar Disorder

Treatments: Other: No weekly review; Behavioral: Weekly review

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03358238

K01MH112876 (U.S. NIH Grant/Contract)

2017-1322 (Other Identifier)

HUM00126732 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

No weekly review

Placebo Comparator group

Description:

Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.

Treatment:

Other: No weekly review

Weekly review

Experimental group

Description:

Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.

Treatment:

Behavioral: Weekly review