LiveWell: A Mobile Intervention for Bipolar Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/24/2018 |
| Start Date: | March 20, 2017 |
| End Date: | July 31, 2020 |
| Contact: | Evan H Goulding, MD/PhD |
| Email: | livewell@northwestern.edu |
| Phone: | 312-503-9095 |
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.
treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions
and improve their effectiveness in reducing symptoms and preventing mood episodes.
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.
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.
Inclusion Criteria:
- Adults 18-65 years
- Bipolar Disorder Type I
- Minimum of 1 acute episode in the last 2 years
Exclusion Criteria:
- 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.
We found this trial at
2
sites
303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Evan Goulding, MD/PhD
Phone: 312-503-9095
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Bloomington, Minnesota 55425
Principal Investigator: Rebecca Rossom, MD
Phone: 952-967-5763
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