1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- University of Melbourne
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale (MADRS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Detailed Description
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: * Moderated peer discussion board * Psychoeducation learning modules * Interactive psychosocial tools This study will also examine whether there is an association between graduated levels of involvement and resulting improvement. These graduated levels are: * Moderated peer discussion board only (Level 1) * Moderated peer discussion board and psychoeducation learning modules (Level 2) * Moderated peer discussion board, psychoeducation learning modules and interactive psychosocial tools (Level 3). 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.
Investigators
Michael Berk
Honorary Adjunct Professor
University of Melbourne
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
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.
Young Mania Rating Scale (YMRS)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
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.
Secondary Outcomes
- Time to Intervention for Mood Episode (TIME)(Change from 3 months to 6 months, 9 months and 12 months)
- SF-12(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Cornell Service Index (CSI)(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Medication Adherence Rating Scale (MARS)(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Patient Satisfaction Questionnaire 18 (PSQ-18)(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Treatment Satisfaction Questionnaire-Modified(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Medical Outcomes Study Social Support Survey (MOS-SSS)(Change from Baseline to 3 months, 6 months, 9 months and 12 months)