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Completed

NCT Number: NCT03088462

LiveWell: A Mobile Intervention for Bipolar Disorder

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.

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Key information

Conditions

Bipolar Disorder Bipolar I Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychiatric management

Other

Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.

Psychosocial treatment

Behavioral

Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.

LiveWell Program

Behavioral

Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Longitudinal Interval Follow-up Evaluation-Clinical Monitoring Form: Symptom Severity

    Time frame: 48 weeks

    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.

  2. Change in Quick Inventory of Depressive Symptomatology-Clinician Rating

    Time frame: At 0, 8, 16, 24, 32, 40 and 48 weeks

    Structured interview designed to assess severity of depression. Scale range is from 0-27.

  3. Change in Young Mania Rating Scale

    Time frame: At 0, 8, 16, 24, 32, 40 and 48 weeks

    Structured interview designed to assess severity of mania. Scale range is from 0-60.

  4. Change in World Health Organization Quality of Life Scale (BREF)

    Time frame: At 0, 24 and 48 weeks

    Structured interview designed to assess physical health, psychological health, social relationships, and environment. Each domain is scored individually with transformed scores of 4-20.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 23, 2017
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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