Internet-Based Interventions for Bipolar Disorder
MoodSwings 2
2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
1 other identifier
interventional
300
1 country
1
Brief Summary
The investigators hope to learn whether access to online support and education can help people with Bipolar Disorder (BD) better manage their symptoms of depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 10, 2015
September 1, 2015
1.9 years
May 16, 2013
September 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Montgomery Asberg Rating Scale (MADRS) for Depression
The MADRS is a 10-item scale, completed by the clinician to assess symptoms of depression. It is particularly sensitive to changes in depression over time. Joint reliability for the total score across several studies ranged from 0.76 to 0.95, and it is viewed as a reliable and valid measure of depression symptoms.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Young Mania Rating Scale
The YMRS is an 11-item scale, completed by the clinician to assess symptoms of mania. This scale is viewed as a reliable and valid measure of manic symptoms, and is sensitive to changes in mania over time.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary Outcomes (8)
Time to Intervention for Mood Episode( TIME)
Changes from Baseline to 3 months, 6 months, 9 months and 12 months
SF-12
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Cornell Service Index (CSI)
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Change from baseline to 3 months, 6 months, 9 months and 12 months
Medication Adherence rating Scale( MARS)
Changes from Baseline to 3 months, 6months, 9 months and 12 months
- +3 more secondary outcomes
Other Outcomes (2)
Inventory Of Stigma Experiences
Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Motivation for Treatment Questionnaire - 8 item ( MTQ 8)
Changes from Baseline to 3 months, 6 months,9months and 12 months
Study Arms (3)
Level 1
ACTIVE COMPARATORModerated discussion board only
Level 2
ACTIVE COMPARATORModerated discussion board plus psychoeducation
Level 3
ACTIVE COMPARATORModerated discussion board plus psychoeducation plus interactive psychosocial tools
Interventions
All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our "peer support" control condition, although we do expect some modest benefit from this intervention alone (Mead et al., 2010). The discussion boards will be moderated by trained clinicians (masters level or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group.
Online psychoeducation is only available to those randomized to Levels 2 and 3. The core modules of MoodSwings 2.0 will use videos and improved organization of content based on feedback from previous pilot work. Module topic areas include: 1. What is bipolar disorder? - Content about symptoms and diagnosis 2. Stress and triggers of illness 3. Medication and the biological basis of bipolar disorder 4. Depression - Symptoms, early detection and helpful strategies 5. Mania and hypomania - Symptoms, early detection and helpful strategies
Online psychosocial tools are only available to those randomized to Level 3. They include structured mood monitoring, medication monitoring, and life charting visual tools. There are also interactive worksheets that encourage awareness of negative thoughts and strategies to challenge them, help participants weight the costs and benefits of different behaviors, problem solving and goal setting, and reinforcing self-affirmation. Participants have the opportunity to build a record of personal triggers of illness and illness profile - including early warning signs, and symptoms typically experienced during an episode of illness, as well as a personal "relapse prevention plan."
Eligibility Criteria
You may qualify if:
- Current diagnosis of bipolar I disorder, bipolar II disorder, or bipolar disorder NOS verified with the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) Mood disorder module.
- Age 21-65.
- Access to a computer with internet access. Access to a printer is preferable, but not required.
- Able to speak and read English proficiently.
- Some degree of medical supervision of bipolar disorder (sees a health professional at least twice a year to discuss symptoms and treatment needs) and local access to emergency care.
You may not qualify if:
- Current psychosis, as assessed in screening phone interview with the SCID psychosis module.
- Acutely suicidal (defined as having a HAM-D item 3, score of ≥3).
- Current mania, assessed using mania module of the SCID mood disorders module.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Palo Alto Health Care Systemlead
- University of Melbournecollaborator
Study Sites (1)
VA Palo Alto Healthcare System
Palo Alto, California, 94304, United States
Related Publications (2)
Gliddon E, Cosgrove V, Berk L, Lauder S, Mohebbi M, Grimm D, Dodd S, Coulson C, Raju K, Suppes T, Berk M. A randomized controlled trial of MoodSwings 2.0: An internet-based self-management program for bipolar disorder. Bipolar Disord. 2019 Feb;21(1):28-39. doi: 10.1111/bdi.12669. Epub 2018 Jun 21.
PMID: 29931798DERIVEDGliddon E, Lauder S, Berk L, Cosgrove V, Grimm D, Dodd S, Suppes T, Berk M. Evaluating discussion board engagement in the MoodSwings online self-help program for bipolar disorder: protocol for an observational prospective cohort study. BMC Psychiatry. 2015 Oct 14;15:243. doi: 10.1186/s12888-015-0630-7.
PMID: 26462799DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Suppes, MD, PhD
VA Palo Alto Health Care System & Stanford University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Bipolar and Depression Research Program
Study Record Dates
First Submitted
May 16, 2013
First Posted
April 7, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
September 10, 2015
Record last verified: 2015-09