Bipolar DisorderNCT03088462
LiveWell: A Mobile Intervention for Bipolar Disorder
A study testing Psychiatric management, Psychosocial treatment and LiveWell Program in people with Bipolar Disorder and Bipolar I Disorder, run by Northwestern University at 2 sites in United States.
Trial summary
LiveWell is a study evaluating the use of smartphones to better understand and improve the treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions and improve their effectiveness in reducing symptoms and preventing mood episodes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Bipolar I Disorder
- What is being tested?
- Psychiatric management, Psychosocial treatment and LiveWell Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2017to 10 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-65 years
- Bipolar Disorder Type I
- Minimum of 1 acute episode in the last 2 years
Who cannot join
- Not receiving psychiatric care
- Current mood episode
- Current substance use disorder (within the last 3 months)
- Current severe suicidal ideation or a recent serious suicide attempt (within the last 3 months)
- Inability to speak and read English
- Visual, hearing, voice, cognitive or motor impairment that would prevent completion of study and treatment procedures
- Participants will need to attend two in-person clinic visits at 680 N Lake Shore Drive, Chicago IL 60611 Suite 1520 or at 3311 E Old Shakopee Rd, Bloomington, MN 55425.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HealthPartners Institute
Bloomington, Minnesota, 55425
Northwestern University
Chicago, Illinois, 60611
About this study
LiveWell is a study evaluating the use of smartphones to better understand and improve the treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions and improve their effectiveness in reducing symptoms and preventing mood episodes.
Read the detailed description
A single blind, randomized controlled trial (N = 200, 2:3 ratio of usual care vs usual care and intervention) will be conducted in clinical practices around Chicago and Minneapolis. Eligible participants are adult bipolar 1 disorder patients not experiencing a current mood episode with a history of at least one acute episode in the last two years who are in treatment with a psychiatrist.
The primary clinical outcome will be time to relapse, and the secondary outcomes will be percent time symptomatic, symptom severity, and quality of life.
Participation in the study lasts for 12 months. Participants are asked to carry a smartphone with them whenever they leave home and wear a wristwatch for measuring activity all day every day. Participants are also asked to complete a series of telephone assessments and may be asked to complete daily check-ins on a smartphone and work with a health coach.
Participants will need to attend two in-person clinic visits at 680 N Lake Shore Drive, Chicago IL 60611 Suite 1520 or at 3311 E Old Shakopee Rd, Bloomington, MN 55425.
- Conditions
- Bipolar Disorder, Bipolar I Disorder
- Being tested
- Psychiatric management, Psychosocial treatment, LiveWell Program
- Keywords
- Bipolar Disorder, Smartphone, Behavior Therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric managementOther
Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.
Psychosocial treatmentBehavioural
Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.
LiveWell ProgramBehavioural
Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | Active comparator | Any treatment for bipolar disorder participant is involved in. Receives: Other: Psychiatric management; Behavioral: Psychosocial treatment |
| Treatment As Usual + LiveWell Program | Experimental | Treatment as usual combined with the LiveWell program. Receives: Other: Psychiatric management; Behavioral: Psychosocial treatment; Behavioral: LiveWell Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status
Semi-structured interview designed to assess clinical status allowing determination of time to relapse (onset of a mood episode).
Clinical Status: episode = depression, mania, hypomania, mixed; continued symptomatic (≥ 3 moderate symptoms without recovery), recovering (≤ 2 moderate symptoms, ≤ 8 weeks), prodromal (≥ 3 moderate symptoms after recovery); recovered (≤ 2 moderate symptoms, ≥ 8 weeks).
Measured: Up to 48 weeks
Secondary outcomes (4)
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity
Semi-structured interview designed to assess symptom severity allowing determination of percent time symptomatic (time with psychiatric status rating > 1.5).
Psychiatric Status Rating: Syndromal Symptoms - 6 = definite criteria with psychotic symptoms or extreme impairment, 5 = definite criteria without psychotic symptoms or extreme impairment; Subsyndromal Symptoms - 4 = not definite criteria but major symptoms or major impairment, 3 = ≥ 3 moderate symptoms, moderate impairment, 2 = ≤ 2 moderate criteria symptoms, minimal impairment; Asymptomatic:1.5 = ≥ 1 mild but no moderate criteria symptoms; 1 = no mild or moderate criteria symptoms.
Measured: 48 weeks
Change in Quick Inventory of Depressive Symptomatology-Clinician Rating
Structured interview designed to assess severity of depression. Scale range is from 0-27.
Measured: At 0, 8, 16, 24, 32, 40 and 48 weeks
Change in Young Mania Rating Scale
Structured interview designed to assess severity of mania. Scale range is from 0-60.
Measured: At 0, 8, 16, 24, 32, 40 and 48 weeks
Change in World Health Organization Quality of Life Scale (BREF)
Structured interview designed to assess physical health, psychological health, social relationships, and environment. Each domain is scored individually with transformed scores of 4-20.
Measured: At 0, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start20 Mar 2017
- Primary completion10 Apr 2020
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Evan Goulding, Northwestern University
- Investigators
- Evan H Goulding, MD/PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088462
- Sponsor's protocol ID
- 1R01MH110626
- Other IDs
- 1R01MH110626
- Status last verified
- Sep 2021
- First submitted
- 8 Mar 2017
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jonathan GK, Abitante G, McBride A, Bernstein-Sandler M, Babington P, Dopke CA, Rossom RC, Mohr DC, Goulding EH. LiveWell, a smartphone-based self-management intervention for bipolar disorder: Intervention participation and usability analysis. J Affect Disord. 2024 Apr 1;350:926-936. doi: 10.1016/j.jad.2024.01.099. Epub 2024 Jan 19.
PubMed 38246280Goulding EH, Dopke CA, Rossom R, Jonathan G, Mohr D, Kwasny MJ. Effects of a Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder on Relapse, Symptom Burden, and Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Feb 1;80(2):109-118. doi: 10.1001/jamapsychiatry.2022.4304.
PubMed 36542401Goulding EH, Dopke CA, Rossom RC, Michaels T, Martin CR, Ryan C, Jonathan G, McBride A, Babington P, Bernstein M, Bank A, Garborg CS, Dinh JM, Begale M, Kwasny MJ, Mohr DC. A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Feb 21;11(2):e30710. doi: 10.2196/30710.
PubMed 35188473
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiveWell: A Mobile Intervention for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03088462
- Acronym / sponsor ID
- 1R01MH110626
- Conditions
- Bipolar Disorder, Bipolar I Disorder
- Keywords
- Bipolar Disorder, Smartphone, Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LiveWell is a study evaluating the use of smartphones to better understand and improve the treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions and improve their effectiveness in reducing symptoms and preventing mood episodes.
Detailed description
A single blind, randomized controlled trial (N = 200, 2:3 ratio of usual care vs usual care and intervention) will be conducted in clinical practices around Chicago and Minneapolis. Eligible participants are adult bipolar 1 disorder patients not experiencing a current mood episode with a history of at least one acute episode in the last two years who are in treatment with a psychiatrist.
The primary clinical outcome will be time to relapse, and the secondary outcomes will be percent time symptomatic, symptom severity, and quality of life.
Participation in the study lasts for 12 months. Participants are asked to carry a smartphone with them whenever they leave home and wear a wristwatch for measuring activity all day every day. Participants are also asked to complete a series of telephone assessments and may be asked to complete daily check-ins on a smartphone and work with a health coach.
Participants will need to attend two in-person clinic visits at 680 N Lake Shore Drive, Chicago IL 60611 Suite 1520 or at 3311 E Old Shakopee Rd, Bloomington, MN 55425.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | Active comparator | Other: Psychiatric management, Behavioral: Psychosocial treatmentAny treatment for bipolar disorder participant is involved in. |
| Treatment As Usual + LiveWell Program | Experimental | Other: Psychiatric management, Behavioral: Psychosocial treatment, Behavioral: LiveWell ProgramTreatment as usual combined with the LiveWell program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18-65 years
- Bipolar Disorder Type I
- Minimum of 1 acute episode in the last 2 years
Key exclusion criteria (7 listed)
- Not receiving psychiatric care
- Current mood episode
- Current substance use disorder (within the last 3 months)
- Current severe suicidal ideation or a recent serious suicide attempt (within the last 3 months)
- Inability to speak and read English
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 |
|---|---|---|
| Psychiatric managementRoutine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy. | Other | Treatment As Usual, Treatment As Usual + LiveWell Program |
| Psychosocial treatmentAny psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups. | Behavioural | Treatment As Usual, Treatment As Usual + LiveWell Program |
| LiveWell ProgramParticipants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder. | Behavioural | Treatment As Usual + LiveWell Program |
Primary outcome
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status
Time frame: Up to 48 weeks
Semi-structured interview designed to assess clinical status allowing determination of time to relapse (onset of a mood episode). Clinical Status: episode = depression, mania, hypomania, mixed; continued symptomatic (≥ 3 moderate symptoms without recovery), recovering (≤ 2 moderate symptoms, ≤ 8 weeks), prodromal (≥ 3 moderate symptoms after recovery); recovered (≤ 2 moderate symptoms, ≥ 8 weeks).
4 secondary outcomes
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity
Time frame: 48 weeks
Change in Quick Inventory of Depressive Symptomatology-Clinician Rating
Time frame: At 0, 8, 16, 24, 32, 40 and 48 weeks
Change in Young Mania Rating Scale
Time frame: At 0, 8, 16, 24, 32, 40 and 48 weeks
Change in World Health Organization Quality of Life Scale (BREF)
Time frame: At 0, 24 and 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Derived from this study: PubMed 38246280Jonathan GK, Abitante G, McBride A, Bernstein-Sandler M, Babington P, Dopke CA, Rossom RC, Mohr DC, Goulding EH. LiveWell, a smartphone-based self-management intervention for bipolar disorder: Intervention participation and usability analysis. J Affect Disord. 2024 Apr 1;350:926-936. doi: 10.1016/j.jad.2024.01.099. Epub 2024 Jan 19.
- Derived from this study: PubMed 36542401Goulding EH, Dopke CA, Rossom R, Jonathan G, Mohr D, Kwasny MJ. Effects of a Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder on Relapse, Symptom Burden, and Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Feb 1;80(2):109-118. doi: 10.1001/jamapsychiatry.2022.4304.
- Derived from this study: PubMed 35188473Goulding EH, Dopke CA, Rossom RC, Michaels T, Martin CR, Ryan C, Jonathan G, McBride A, Babington P, Bernstein M, Bank A, Garborg CS, Dinh JM, Begale M, Kwasny MJ, Mohr DC. A Smartphone-Based Self-management Intervention for Individuals With Bipolar Disorder (LiveWell): Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Feb 21;11(2):e30710. doi: 10.2196/30710.
- Individual participant dataSharing planned: Undecided
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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.
Evan H Goulding, MD/PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric management, Psychosocial treatment and LiveWell Program in people with Bipolar Disorder and Bipolar I Disorder, run by Northwestern University 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 3 inclusion and 7 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 4 Oct 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Clinical Status (time frame: Up to 48 weeks). 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 NCT03088462, which also lists 3 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 4 Oct 2021.