LiveWell: A Mobile Intervention for Bipolar Disorder

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
LiveWell: A Mobile Intervention for Bipolar Disorder

Conditions
-----------------
Bipolar Disorder, Bipolar I Disorder

Intervention / Treatment
-----------------
* Other: Psychiatric management
* Behavioral: Psychosocial treatment
* Behavioral: LiveWell Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment As Usual<br>Any treatment for bipolar disorder participant is involved in. | Other: Psychiatric management<br>* Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.<br>Behavioral: Psychosocial treatment<br>* Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.<br>|
| Experimental: Treatment As Usual + LiveWell Program<br>Treatment as usual combined with the LiveWell program. | Other: Psychiatric management<br>* Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.<br>Behavioral: Psychosocial treatment<br>* Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.<br>Behavioral: LiveWell Program<br>* Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | At 0, 24 and 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Smartphone, Behavior Therapy