Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000409673
Ethics application status
Approved
Date submitted
7/04/2014
Date registered
15/04/2014
Date last updated
15/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
MoodSwings: An Online Self Help Program for Bipolar Disorder
Scientific title
MoodSwings 2.0: A Randomised Controlled Trial Assessing the Effectiveness of an Internet-Based Intervention for Bipolar Disorder on Mood Symptom Severity
Secondary ID [1] 284401 0
Nil
Universal Trial Number (UTN)
U1111-1155-4445
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 291585 0
Condition category
Condition code
Mental Health 291963 291963 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of three groups, which will have varying levels of access to the MoodSwings Internet-Based Intervention for Bipolar Disorder. The first group is the control group (see below), while the second and third groups allow partial and full access to the MoodSwings program content. Program content includes a series of nine learning modules, which cover a number of topics related to bipolar disorder. The first five learning modules are made available fortnightly, and the last 4 modules are released at 3, 6, 9 and 12 months after program commencement. Program content also includes a series of interactive tools, which allow users to monitor their moods, and work on strategies to better manage their bipolar disorder. These tools are also made available fortnightly. Once released, tools and modules remain available for the remainder of the 12 month study period. In addition to the MoodSwings program content, all groups will also have access to an online discussion board. There are three separate boards, with one for each group.

The two treatment groups are:
Level 2: Access to a moderated discussion board and a series of learning modules.
Level 3: Access to a moderated discussion board, a series of learning modules and a number of interactive tools.

All posts submitted to the discussion boards will be moderated by research staff members, who will be supervised by trained clinicians. The discussion board moderators will post new topics for discussion at least once per month; however they will not otherwise engage in discussion.

Participants will have access to the program for a total of 12 months. They will be assessed both online and over the phone at baseline then followed up at 3, 6, 9 and 12 months from program commencement.

To encourage adherence, participants will receive automated reminder messages if they do not log in to the program for 2 weeks. The research team are also able to track log in records to monitor adherence, however there are no other strategies in place to encourage adherence as we plan to observe natural usage patterns.
Intervention code [1] 289139 0
Treatment: Other
Comparator / control treatment
The first group in this study is the control group:
Level 1: Access to a moderated discussion board

There are a total of three discussion boards involved in the MoodSwings program, with one board allocated to each group.

All posts submitted to the discussion boards will be moderated by research staff members, who will be supervised by trained clinicians. The discussion board moderators will post new topics for discussion at least once per month; however they will not otherwise engage in discussion.
Control group
Active

Outcomes
Primary outcome [1] 291869 0
Depression symptom severity (measured by Montgomery-Asberg Depression Rating Scale (MADRS))
Timepoint [1] 291869 0
Changes assessed quarterly over 12 month study period
Primary outcome [2] 291887 0
Mania symptom severity (measured by Young Mania Rating Scale (YMRS))
Timepoint [2] 291887 0
Changes assessed quarterly over 12 month study period
Secondary outcome [1] 307702 0
Health service utilization (measured by Cornell Service Index)
Timepoint [1] 307702 0
Changes assessed quarterly over 12 month study period
Secondary outcome [2] 307741 0
Relapse (measured by Time to Intervention for Mood Episode (TIME))
Timepoint [2] 307741 0
Changes assessed quarterly over 12 month study period
Secondary outcome [3] 307742 0
Functioning (measured by SF-12)
Timepoint [3] 307742 0
Changes assessed quarterly over 12 month study period
Secondary outcome [4] 307743 0
Social support (measured by Medical Outcomes Study - Social Support Survey (MOS-SSS))
Timepoint [4] 307743 0
Changes assessed quarterly over 12 month study period
Secondary outcome [5] 307744 0
Quality of life (measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q))
Timepoint [5] 307744 0
Changes assessed quarterly over 12 month study period
Secondary outcome [6] 307745 0
Medication adherence (measured by Medication Adherence Rating Scale (MARS))
Timepoint [6] 307745 0
Changes assessed quarterly over 12 month study period
Secondary outcome [7] 307746 0
Treatment satisfaction (measured by Patient Satisfaction Questionnaire 18 item (PSQ-18))
Timepoint [7] 307746 0
Changes assessed quarterly over 12 month study period

Eligibility
Key inclusion criteria
- Current diagnosis of bipolar I disorder, bipolar II disorder or bipolar disorder not otherwise specified (confirmed by Structured Clinical Interview for DSM (SCID))
- Aged 21 to 65 years
- Access to a computer with an internet connection
- Able to speak and read English proficiently
- Sees a health care professional at least twice per year to discuss bipolar disorder symptoms and treatment needs
- Local access to emergency care
- Willing to provide emergency contact details
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current psychosis (confirmed by Structured Clinical Interview for DSM (SCID))
- Current mania (confirmed by Structured Clinical Interview for DSM (SCID))
- Acutely suicidal (confirmed by Hamilton Rating Scale for Depression (HAM-D) item 3)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant screening is completed by a blinded interviewer. Once deemed eligible, participants are randomised automatically by the MoodSwings online program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, created by computer software
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
Efficacy
Statistical methods / analysis
Based upon definitions of the minimal meaningful clinical difference observed in most clinical trials of persons with bipolar disorder, we have defined a reduction of 3.5 points on the Montgomery-Asberg Depression Rating Scale (MADRS) as a meaningful clinical outcome. An estimate of 300 patients (100 per group) will be more than adequate to detect, with 80% power, a time-averaged difference of 3.5 points on the MADRS scale. This calculation assumes a significance level alpha of 0.05, four post assessments, serial correlation equal to 0.4, standard deviation of 10 points and 20% attrition (Liu & Wu, 2005).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/03/2014
Actual
27/03/2014
Date of last participant enrolment
Anticipated
27/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2330 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment outside Australia
Country [1] 5971 0
United States of America
State/province [1] 5971 0
California, Palo Alto

Funding & Sponsors
Funding source category [1] 289050 0
Government body
Name [1] 289050 0
National Institutes of Health
Country [1] 289050 0
United States of America
Primary sponsor type
University
Name
University of Melbourne
Address
1-100 Grattan Street, Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 287718 0
None
Name [1] 287718 0
Address [1] 287718 0
Country [1] 287718 0
Other collaborator category [1] 277917 0
Hospital
Name [1] 277917 0
VA Palo Alto
Address [1] 277917 0
3801 Miranda Ave, Palo Alto, CA 94304, United States
Country [1] 277917 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290847 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 290847 0
Kitchener House
Ryrie Street
Geelong, VIC, 3220
Ethics committee country [1] 290847 0
Australia
Date submitted for ethics approval [1] 290847 0
23/09/2011
Approval date [1] 290847 0
03/10/2011
Ethics approval number [1] 290847 0
HREC/11/VICBH/47

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 useful. Specifically, the study will examine (1) whether exposure to the MoodSwings 2.0 intervention results in decreased depression and manic symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) respectively; and (2) whether there is an association between graduated levels of involvement (Level 1, 2, or 3) and resulting improvement. We expect that those assigned to the control condition (Level 1) will have fewer positive outcomes than those in Level 2 or 3.
Trial website
www.moodswings.net.au
Trial related presentations / publications
Public notes
This trial is recruiting internationally, with coordinating centres located in Geelong, Australia and Palo Alto, United States. There are no geographical restrictions for participants.

Contacts
Principal investigator
Name 47566 0
Prof Michael Berk
Address 47566 0
IMPACT SRC - Kitchener House
Ryrie Street, Geelong, VIC, 3220
Country 47566 0
Australia
Phone 47566 0
+613 4215 3330
Fax 47566 0
Email 47566 0
[email protected]
Contact person for public queries
Name 47567 0
Miss Emma Gliddon
Address 47567 0
IMPACT SRC - Kitchener House
Ryrie Street, Geelong, VIC, 3220
Country 47567 0
Australia
Phone 47567 0
+613 4215 3311
Fax 47567 0
Email 47567 0
[email protected]
Contact person for scientific queries
Name 47568 0
Miss Emma Gliddon
Address 47568 0
IMPACT SRC - Kitchener House
Ryrie Street, Geelong, VIC, 3220
Country 47568 0
Australia
Phone 47568 0
+613 4215 3311
Fax 47568 0
Email 47568 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.