A Pilot Study of Functional Remediation for Bipolar Disorder: Feasibility and Preliminary Efficacy
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Bipolar Disorder
- 发起方
- University of Michigan
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
Bipolar Disorder is a major mood disorder with periodic mood episodes that may be very distressing, both to the individual and to others. When ill, the person is at particular risk for disruptions to social and occupational functioning, physical health, and even premature death. When not in an episode, individuals with BD may still be feeling well but have ongoing neurobiological processes, as well as the psychological sequelae from illness episodes, that can lead to subtle neurocognitive impairment that impedes overall functioning. This study is a test of an existing, published intervention that ameliorates deficits in functioning in euthymic bipolar individuals.
研究者
Sagar Parikh
Professor of Psychiatry
University of Michigan
入排标准
入选标准
- •diagnosis of bipolar I or II disorder (BD), as determined by a structured diagnostic interview
- •at least three months of clinical remission (euthymia or minimal symptoms), based on the phone screen assessing mood episodes in the prior three months
- •score greater than 11 on a measure of everyday functioning (FAST; described in measures section) indicating at least mild impairment
- •use of a standard bipolar mood-stabilizing medication at the same, adequate dose (according to CANMAT treatment guidelines) for at least 3 months prior to screening, with ability to continue that dose during the study.
排除标准
- •history of neurological illness or injury (e.g., stroke, brain tumor)
- •documented intellectual disability
- •inability to provide written informed consent
- •substance dependence within last 3 months or substance abuse in last 30 days
- •inability to complete the six-month intervention
- •received ECT in the past 12 months
结局指标
主要结局
Feasibility
时间窗: 30 weeks
Feasibility will be determined by a composite of ability to recruit and deliver the treatment intervention to both cohorts of participants, with adequate delivery of the intervention as measured by completion of the manual's objectives.
Acceptability (Subject Satisfaction)
时间窗: 30 weeks
Acceptability of the intervention will be measured by use of the Satisfaction with Therapy and Therapist Scale.
Acceptability (Subject completion)
时间窗: 30 weeks
Measured by percentage of subjects who complete the intervention.
次要结局
- Functional Impact(30 weeks)