1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Level 1
Moderated discussion board only
干预措施: Moderated discussion board (Behavioral)
Level 2
Moderated discussion board plus psychoeducation
干预措施: Moderated discussion board (Behavioral)
Level 2
Moderated discussion board plus psychoeducation
干预措施: Psychoeducation (Behavioral)
Level 3
Moderated discussion board plus psychoeducation plus interactive psychosocial tools.
干预措施: Interactive Psychosocial Tools (Behavioral)
Level 3
Moderated discussion board plus psychoeducation plus interactive psychosocial tools.
干预措施: Moderated discussion board (Behavioral)
Level 3
Moderated discussion board plus psychoeducation plus interactive psychosocial tools.
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Michael Berk
Honorary Adjunct Professor
University of Melbourne