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| Name | Class |
|---|---|
| VA Palo Alto Health Care System | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level 1 | Active Comparator | Moderated discussion board only |
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| Level 2 | Active Comparator | Moderated discussion board plus psychoeducation |
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| Level 3 | Active Comparator | Moderated discussion board plus psychoeducation plus interactive psychosocial tools. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderated discussion board | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from 3 months to 6 months, 9 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inventory of Stigma Experiences | This scale will be used to measure both the self-reported experiences of stigma and the impact of stigma. | Change from Baseline to 3 months, 6 months, 9 months and 12 months |
| Motivation for Treatment Questionnaire - 8 item (MTQ-8) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Berk, FFPsych, PhD | Deakin University and University of Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Melbourne - Barwon Health | Geelong | Victoria | 3220 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29931798 | Derived | 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. | |
| 26462799 | Derived | 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. |
| Label | URL |
|---|---|
| MoodSwings website | View source |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Psychoeducation | Behavioral | 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:
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| Interactive Psychosocial Tools | Behavioral | 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". |
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| 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. | 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). | 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. | 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. | 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. | 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. | 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. | Change from Baseline to 3 months, 6 months, 9 months and 12 months |
The Motivation for Treatment Questionnaire (MTQ-8) consists of eight questions to assess motivational reasons to seek treatment. |
| Change from Baseline to 3 months, 6 months, 9 months and 12 months |