Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
1 other identifier
interventional
304
1 country
1
Brief Summary
This study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be most useful.
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
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 26, 2017
October 1, 2017
2.3 years
April 15, 2014
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Montgomery-Asberg Depression Rating Scale (MADRS)
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 (YMRS)
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)
Change from 3 months to 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)
Change from Baseline to 3 months, 6 months, 9 months and 12 months
- +3 more secondary outcomes
Other Outcomes (2)
Inventory of Stigma Experiences
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Motivation for Treatment Questionnaire - 8 item (MTQ-8)
Change from Baseline to 3 months, 6 months, 9 months 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. The discussion boards will be moderated by research staff, who will be supervised by a trained clinician (masters levels 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 behaviours, 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 not otherwise specified (NOS) verified with the Structured Clinical Interview for the Diagnostic Manual for Mental Disorders (SCID) mood disorders module.
- Age 21 to 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).
- Local access to emergency care.
You may not qualify if:
- Current psychosis, as assessed in screening phone interview with the SCID psychotic screening module.
- Acutely suicidal (defined as having a Hamilton Rating Scale for Depression \[HAM-D\] item 3 scores of ≥ 3)
- Current mania, assessed using the SCID mood disorder module.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Melbournelead
- VA Palo Alto Health Care Systemcollaborator
Study Sites (1)
University of Melbourne - Barwon Health
Geelong, Victoria, 3220, Australia
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
Michael Berk, FFPsych, PhD
Deakin University and University of Melbourne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Adjunct Professor
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 21, 2014
Study Start
January 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
October 26, 2017
Record last verified: 2017-10