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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02118623




Registration number
NCT02118623
Ethics application status
Date submitted
15/04/2014
Date registered
21/04/2014
Date last updated
26/10/2017

Titles & IDs
Public title
Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
Scientific title
1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Secondary ID [1] 0 0
1R34MH091384
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Moderated discussion board
BEHAVIORAL - Psychoeducation
BEHAVIORAL - Interactive Psychosocial Tools

Active comparator: Level 1 - Moderated discussion board only

Active comparator: Level 2 - Moderated discussion board plus psychoeducation

Active comparator: Level 3 - Moderated discussion board plus psychoeducation plus interactive psychosocial tools.


BEHAVIORAL: Moderated discussion board
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.

BEHAVIORAL: Psychoeducation
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.

BEHAVIORAL: Interactive Psychosocial Tools
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".
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Primary outcome [2] 0 0
Young Mania Rating Scale (YMRS)
Timepoint [2] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcome [1] 0 0
Time to Intervention for Mood Episode (TIME)
Timepoint [1] 0 0
Change from 3 months to 6 months, 9 months and 12 months
Secondary outcome [2] 0 0
SF-12
Timepoint [2] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcome [3] 0 0
Cornell Service Index (CSI)
Timepoint [3] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcome [4] 0 0
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Timepoint [4] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcome [5] 0 0
Medication Adherence Rating Scale (MARS)
Timepoint [5] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcome [6] 0 0
Patient Satisfaction Questionnaire 18 (PSQ-18)
Timepoint [6] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcome [7] 0 0
Treatment Satisfaction Questionnaire-Modified
Timepoint [7] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcome [8] 0 0
Medical Outcomes Study Social Support Survey (MOS-SSS)
Timepoint [8] 0 0
Change from Baseline to 3 months, 6 months, 9 months and 12 months

Eligibility
Key inclusion criteria
* 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.
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
304
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
VA Palo Alto Health Care System
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02118623
Trial related presentations / publications
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.
Gliddon 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.
Public notes

Contacts
Principal investigator
Name 0 0
Michael Berk, FFPsych, PhD
Address 0 0
Deakin University and University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02118623