None listed
Conditions
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.
Interventions
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 fortnig
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.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Healthy volunteers
No
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
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)
Outcome results
None listed