Bipolar DisorderNCT03358238

Modeling Mood Course to Detect Markers of Effective Adaptive Interventions

A study testing Weekly review and No weekly review in people with Bipolar Disorder, run by University of Wisconsin, Madison at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Bipolar Disorder
What is being tested?: Weekly review and No weekly review
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 2 sitesUnited States
Study dates: 27 Nov 2017to 19 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals diagnosed with bipolar disorder
Individuals with a smart-phone

Who cannot join

None

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan
Ann Arbor, Michigan, 48105
University of Wisconsin
Madison, Wisconsin, 53792

Other trials in United States

About this study

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.

Read the 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.

Conditions: Bipolar Disorder
Being tested: Weekly review, No weekly review
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Weekly reviewBehavioural
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.
No weekly reviewOther
Also called Placebo
An interviewer will not review self-report symptoms and patterns collected from an activity tracker.

Study groups in NCT03358238
Study group	Role	What they receive
No weekly review	Placebo comparator	Individuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone. Receives: Other: No weekly review
Weekly review	Experimental	Individuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone. Receives: Behavioral: Weekly review

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Study end (6 weeks)
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).
Measured: Study end (6 weeks)
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)
Measured: Study end (6 weeks)
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.
Measured: Study end (6 weeks)

Secondary outcomes (2)

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.
Measured: 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
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.
Measured: Baseline, study end (6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 201719 Jun 2019

First posted30 Nov 2017
Study start27 Nov 2017
Primary completion19 Jun 2019
Study completion19 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03358238
Sponsor's protocol ID: K01MH112876
Other IDs: K01MH112876, HUM00126732, 2017-1322
Status last verified: Jun 2020
First submitted: 26 Nov 2017
Last updated: 9 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Van Til K, McInnis MG, Cochran A. A comparative study of engagement in mobile and wearable health monitoring for bipolar disorder. Bipolar Disord. 2020 Mar;22(2):182-190. doi: 10.1111/bdi.12849. Epub 2019 Oct 25.
PubMed 31610074
Cochran A, Belman-Wells L, McInnis M. Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 10;7(5):e130. doi: 10.2196/resprot.9899.
PubMed 29748160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modeling Mood Course to Detect Markers of Effective Adaptive Interventions
ClinicalTrials.gov ID: NCT03358238
Acronym / sponsor ID: K01MH112876
Conditions: Bipolar Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: University of Michigan, National Institute of Mental Health (NIMH)
Study start: 27 Nov 2017 (actual)
Primary completion: 19 Jun 2019 (actual)
Study completion: 19 Jun 2019 (actual)
First posted: 30 Nov 2017 (actual)
Results: Posted 9 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
No weekly review	Placebo comparator	Other: No weekly reviewIndividuals will not review self-report and activity tracker data with an interviewer on a weekly basis over the phone.
Weekly review	Experimental	Behavioral: Weekly reviewIndividuals will review self-report and activity tracker data with an interviewer on a weekly basis over the phone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Individuals diagnosed with bipolar disorder
Individuals with a smart-phone

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Weekly reviewEach 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.	Behavioural	Weekly review
No weekly reviewAlso: PlaceboAn interviewer will not review self-report symptoms and patterns collected from an activity tracker.	Other	No weekly review

Primary outcome

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.
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).
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)
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.

2 secondary outcomes

Average Change From Baseline in Severity of Manic Symptoms, as Measured With the Young Mania Rating Scale
Time frame: 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)

Results and safety

Results posted to the registry on 9 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Weekly Review	23	23
Weekly Review	25	24

Primary outcome: 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). Number (95% Confidence Interval). Unit: proportion of participants

Measure	All Participants n = 47
Value	0.404 (0.264 to 0.557)

All Participants: Proportion: 0.404 (95% CI 0.264 to 0.557)

Population analysed: 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.

Primary outcome: Average Proportion of Study Days With At Least 50% Completion of Daily Self-Reports Questions

Time frame: Study end (6 weeks). Mean (95% Confidence Interval). Unit: proportion of study days

Measure	Review Arm n = 24	No Review Arm n = 23
Value	0.8185 (0.6954 to 0.9415)	0.8168 (0.6865 to 0.9470)

Review Arm vs No Review Arm: Difference in Average Proportions: .0017 (95% CI -0.1774 to 0.1807), p = 0.99, t-test, 2 sided

Primary outcome: Average Proportion of Study Days With At Least 12 Hours of Activity Tracking

Time frame: Study end (6 weeks). Mean (95% Confidence Interval). Unit: proportion of study days

Measure	Review Arm n = 24	No Review Arm n = 23
Value	0.7688 (0.6323 to 0.9054)	0.7878 (0.6376 to 0.9379)

Review Arm vs No Review Arm: Risk Difference (RD): -0.0189 (95% CI -0.2215 to 0.1837), p = 0.85, t-test, 2 sided

Primary outcome: Proportion of Participants Who Have Higher Adherence Rates for Self-reporting Symptoms Than Adherence Rates for Activity Tracking

Time frame: Study end (6 weeks). Number (95% Confidence Interval). Unit: Proportion of participants

Measure	Review Arm Participants With Unequal Adherence n = 21	No Review Arm Participants With Unequal Adherence n = 18
Value	0.6667 (0.4303 to 0.8541)	0.3889 (0.1730 to 0.6425)

Review Arm Participants With Unequal Adherence vs No Review Arm Participants With Unequal Adherence: Proportion: 0.5385 (95% CI 0.3718 to 0.6991)
Review Arm Participants With Unequal Adherence vs No Review Arm Participants With Unequal Adherence: p = 0.0828, Chi-squared

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a period of six weeks for each individual participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Weekly Review	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23
Weekly Review	1 of 24 (4.2%)	2 of 24 (8.3%)	0 of 24

Limitations and caveats (from the sponsor): Results regarding passive activity tracking may not generalize to other forms of passive tracking. Small sample sizes. Not powered to examine individual differences in responses to engagement survey at study end.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31610074Van Til K, McInnis MG, Cochran A. A comparative study of engagement in mobile and wearable health monitoring for bipolar disorder. Bipolar Disord. 2020 Mar;22(2):182-190. doi: 10.1111/bdi.12849. Epub 2019 Oct 25.
Derived from this study: PubMed 29748160Cochran A, Belman-Wells L, McInnis M. Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 10;7(5):e130. doi: 10.2196/resprot.9899.
Individual participant dataSharing planned: No

Related trials for Bipolar Disorder

Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 2
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
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RecruitingObservational study
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Recruiting
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy L Cochran, PhD principal investigator

University of Wisconsin, Madison

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Weekly review and No weekly review in people with Bipolar Disorder, run by University of Wisconsin, Madison at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03358238, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.