A Pilot Study of Functional Remediation for Bipolar Disorder: Feasibility and Preliminary Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Receiving Psychosocial Intervention
Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities.
干预措施: Functional Remediation (Other)
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)
研究者
Sagar Parikh
Professor of Psychiatry
University of Michigan