Bipolar Disorder
Conditions
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.
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.
Interventions
BEHAVIORALWeekly 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.
OTHERNo weekly review
An interviewer will not review self-report symptoms and patterns collected from an activity tracker.
Sponsors
University of Michigan
National Institute of Mental Health (NIMH)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals diagnosed with bipolar disorder * Individuals with a smart-phone
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms | 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. |
| Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions | 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). |
| Average Proportion of Study Days With At Least 12 Hours of Activity Tracking | 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) |
| Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking | 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
| Measure | Time frame | Description |
|---|---|---|
| Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Two participants were enrolled and subsequently excluded before the start of the study. One of these individuals died between the consent date and the start of the study, and the other was lost to follow-up between the consent date and study start.
Participants by arm
| Arm | Count |
|---|---|
| No Weekly Review Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
No weekly review: An interviewer will not review self-report symptoms and patterns collected from an activity tracker. | 23 |
| Weekly Review Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
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. | 25 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Weekly Review | No Weekly Review |
|---|---|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 10.8 | 41.0 years STANDARD_DEVIATION 10.6 | 42.4 years STANDARD_DEVIATION 11.2 |
| Diagnosis Bipolar I | 33 participants | 16 participants | 17 participants |
| Diagnosis Bipolar II | 12 participants | 6 participants | 6 participants |
| Diagnosis Bipolar NOS | 3 participants | 3 participants | 0 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 22 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 22 Participants | 19 Participants |
| Region of Enrollment United States | 47 participants | 25 participants | 23 participants |
| Sex: Female, Male Female | 26 Participants | 14 Participants | 12 Participants |
| Sex: Female, Male Male | 22 Participants | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 1 / 23 | 2 / 24 |
| serious Total, serious adverse events | 0 / 23 | 1 / 24 |
Outcome results
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)
Time frame: Study end (6 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Average Proportion of Study Days With At Least 12 Hours of Activity Tracking | 0.7688 proportion of study days |
| No Review Arm | Average Proportion of Study Days With At Least 12 Hours of Activity Tracking | 0.7878 proportion of study days |
Comparison: Null hypothesis was that the difference in average adherence rates to activity tracking between arms was zero.p-value: 0.8595% CI: [-0.2215, 0.1837]t-test, 2 sided
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).
Time frame: Study end (6 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions | 0.8185 proportion of study days |
| No Review Arm | Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions | 0.8168 proportion of study days |
Comparison: Null hypothesis was that the difference in average adherence rates of self-reporting between arms was zero.p-value: 0.9995% CI: [-0.1774, 0.1807]t-test, 2 sided
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.
Time frame: Study end (6 weeks)
Population: For an individual, adherence rate for self-report is proportion of days with at least 50% completion of self-report questions; adherence rate for activity tracking is proportion of days with at least 12 hours of activity tracking.~Participants with no difference in adherence rates between self-report and activity tracking were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking | 0.6667 Proportion of participants |
| No Review Arm | Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking | 0.3889 Proportion of participants |
Comparison: Estimating proportion of individuals with higher adherence rates for self-report over activity tracking among individuals with unequal adherence rates95% CI: [0.3718, 0.6991]
Comparison: Null hypothesis is that among individuals with unequal adherence rates, the proportion of individuals with greater adherence to self-report over activity tracking in the Review Arm is equal to the proportion of individuals with greater adherence to self-report over activity tracking in the No Review Arm.p-value: 0.0828Chi-squared
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.
Time frame: Study end (6 weeks)
Population: The analysis population includes both arms (rather than reporting outcomes by arm). Goals of this study went beyond measuring arm effects. Here, the question of interest is across the sample, do individuals prefer self-reporting over using an activity tracker. It is not of interest to know if the intervention changes this preference.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Proportion of Participants Who Report They Are More Likely to Use a Smart-phone App Over an Activity Tracker to Monitor Their Symptoms | 0.404 proportion of participants |
95% CI: [0.264, 0.557]
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.
Time frame: Baseline, study end (6 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | 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 | 0.67 score on a scale |
| No Review Arm | 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 | 1.13 score on a scale |
Comparison: Null hypothesis was that average change in scores on the structured interview guide for the Hamilton rating scale for depression is zero.p-value: 0.3295% CI: [-0.91, 2.7]t-test, 2 sided
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.
Time frame: Baseline, study end (6 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale | 0.67 score on a scale |
| No Review Arm | Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale | 0.91 score on a scale |
Comparison: One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~Null hypothesis was that the average change in total scores was zero.p-value: 0.295% CI: [-0.42, 1.99]t-test, 2 sided