An interventional study of Moderated discussion board and Psychoeducation in Bipolar Disorder, sponsored by University of Melbourne. Completed at 1 site in Australia. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by University of Melbourne · Not applicable, Interventional, and Supportive care
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.
This study will examine whether exposure to the three different components of the MoodSwings 2.0 intervention results in decreased depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS), and decreased manic symptoms as measured by the Young Mania Rating Scale (YMRS). The three components of the MoodSwings 2.0 intervention are:
This study will also examine whether there is an association between graduated levels of involvement and resulting improvement. These graduated levels are:
We expect that those participants assigned to the control condition (Level 1), will have fewer positive outcomes than those in Level 2 or Level 3 conditions.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 304 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University of Melbourne is the lead sponsor of 84 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Moderated discussion board only
Behavioral: Moderated discussion board
Moderated discussion board plus psychoeducation
Behavioral: Moderated discussion board · Behavioral: Psychoeducation
Moderated discussion board plus psychoeducation plus interactive psychosocial tools.
Behavioral: Moderated discussion board · Behavioral: Psychoeducation · Behavioral: Interactive Psychosocial Tools
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.
Also known as: discussion board, online discussion, online posts, online discussion boards, forum, discussion forum, support group, discussion 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.
Also known as: Online psychoeducation, Online education, Education
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".
Also known as: Interactive tools, Online tools, Online interactive tools
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.
Time frame: 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.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Time to Intervention for Mood Episode (TIME)
Relapse or time to invention will be assessed using the TIME scale, with intervention defined as initiation, discontinuation, or dose adjustment of a treatment, initiation of psychotherapy or ECT, visit to an emergency provider or hospitalization in response to new mood symptoms.
Time frame: Change from 3 months to 6 months, 9 months and 12 months
SF-12
The SF-12 is a short, multipurpose measure of perceived impairment due to health problems. It is widely used as a short version of the SF-36, and has good validity. The SF-12 yields two risk-adjusted summary scores, impairment perceived as due to physical illness, and impairment perceived due to emotional problems.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Cornell Service Index (CSI)
Use of general medical and psychiatric health services will be collected via the Cornell Service Index (CSI). The CSI is a brief assessment of health service use. It has good inter-rater and test-retest reliability and assesses four types of services: outpatient psychiatric or psychological services (e.g. psychotropic medication visits or psychotherapy), outpatient medical services (e.g. visits to medical providers), professional support services (e.g. home health nurse visits, meal delivery), and intensive services (e.g. emergency department visits or hospitalization).
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
The Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) assesses subjective quality of life (i.e. physical health, subjective feelings, leisure activities and social relationships). The 16-item short form is designed to measure satisfaction with various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Medication Adherence Rating Scale (MARS)
When applicable, adherence to prescribed medication will be assessed with the Medication Adherence Rating Scale (MARS). This 10-item scale has acceptable reliability, with Cronbach's alpha 0.75, and test re-test reliability 0.72. It is seen as a valid measure with significant correlations with other measures of medication adherence (p\<.01) and with serum blood levels at p\<.05.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Patient Satisfaction Questionnaire 18 (PSQ-18)
The Patient Satisfaction Questionnaire 18 (PSQ-18) assesses the overall satisfaction of each participant with their current medical care. This 18-item scale is a short form version of the 50-item Patient Satisfaction Questionnaire. The PSQ sub-scales show acceptable internal consistency reliability. Furthermore, corresponding PSQ-18 and PSQ-III subscales are substantially correlated with one another.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Treatment Satisfaction Questionnaire-Modified
For the purposes of this study, the Treatment Satisfaction Questionnaire-Modified was revised to suit bipolar disorder and the MoodSwings 2.0 program. This questionnaire was originally a modified version of the Treatment Satisfaction Questionnaire.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Medical Outcomes Study Social Support Survey (MOS-SSS)
Social support will be assessed with the Medical Outcomes Study Social Support Survey. This 18-item scale has acceptable reliability (alpha \>0.91) and construct validity, and was specifically developed for people with chronic conditions.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Inventory of Stigma Experiences
This scale will be used to measure both the self-reported experiences of stigma and the impact of stigma.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Motivation for Treatment Questionnaire - 8 item (MTQ-8)
The Motivation for Treatment Questionnaire (MTQ-8) consists of eight questions to assess motivational reasons to seek treatment.
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Melbourne