Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy
赞助:
University of Vermont
合作者:
信息的提供 (责任方):
Kelly Rohan，University of Vermont
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | September 1, 2018 | ||
| 预计主要完成日期 | February 28, 2023 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Structured Interview Guide for the Hamilton Rating Scale for Depression—Seasonal Affective Disorder Version (SIGH-SAD)[ Time Frame: past 1 week ] Semi-structured interview of depressive symptoms Beck Depression Inventory-Second Edition (BDI-II)[ Time Frame: past 2 weeks ] self-report measure of depressive symptoms |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy | ||
| 正式标题 ICMJE | Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy: Confirming the Targets, Mechanisms, and Treatment Sequence | ||
| 简要概况 | Major depression is a highly prevalent, chronic, and debilitating mental health problem with significant social cost that poses a tremendous economic burden. Winter seasonal affective disorder (SAD) is a subtype of recurrent major depression that affects 5% of the population (14.5 million Americans), involving substantial depressive symptoms for about 5 months of each year during most years, beginning in young adulthood. |
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| 详细说明 | Winter seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit each spring. The central public health challenge in the management of SAD is prevention of winter depression recurrences. This application focuses on two SAD treatments that each work for some patients: light therapy (LT) and a SAD-tailored group cognitive-behavioral therapy (CBT-SAD). LT is the acute SAD treatment with the most substantial evidence to support its efficacy. Correction of circadian phase is LT's established target and mechanism. In our recently completed R01-level efficacy trial, post-treatment outcomes for CBT-SAD and LT were very similar, but CBT-SAD was associated with fewer depression recurrences over 2-year followup than LT (27.3% in CBT-SAD vs. 45.6% in LT). CBT-SAD engaged and altered a specific mechanism of action, seasonal beliefs, which improved at twice the rate during CBT-SAD compared to LT, and this improvement was associated with lower risk for recurrence following CBT-SAD. This confirmatory efficacy R01 will apply the experimental therapeutics approach to determine how each treatment works when it is effective and to identify the best candidates for each. We will ascertain whether theoretically-derived candidate biomarkers of each treatment's target and effect are prescriptive of better outcomes in that treatment vs. the other. Biomarkers of LT's target and effect include circadian phase angle difference (PAD) and the post-illumination pupil response (PIPR). Biomarkers of CBT-SAD's target and effect include pupil dilation and sustained gamma band EEG responses to seasonal words, which are hypothesized to reflect less engagement with seasonal stimuli following CBT-SAD and corroborate with the established target of seasonal beliefs. In addition to determining change mechanisms, we will test the efficacy of a "switch" decision rule upon recurrence to inform clinical decision-making in practice. We will randomize 160 adults with SAD to 6-weeks of CBT-SAD or LT in Winter 1; follow subjects in Winter 2; and, if a depression recurrence occurs, cross them over into the alternate treatment (i.e., switch from LT to CBT-SAD or CBT-SAD to LT). All subjects will be followed in Winter 3. Biomarker assessments will occur at pre-, mid-, and post-treatment in Winter 1, at Winter 2 followup (and again at mid-/post-treatment for those crossed-over), and at Winter 3 followup. Consistent with NIMH's priorities for demonstrating target engagement at the level of RDoC-relevant biomarkers, this work aims to confirm the targets and mechanisms of LT and CBT-SAD to maximize the impact of future dissemination efforts. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2/Phase 3 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: head-to-head RCT 盲法: Interventional 盲法描述:Outcomes are rated on a semi-structured interview by raters blind to treatment assignment. 主要目的: Treatment |
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| 干预项目 ICMJE |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
160 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | February 28, 2023 | ||
| 预计主要完成日期 | February 28, 2023 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Principle DSM-5 diagnosis of Major Depression, Recurrent, with Seasonal Pattern. -Meet Structured Interview Guide for the Hamilton Rating Scale for Depression—Seasonal Affective Disorder Version (SIGH-SAD) criteria for a current SAD episode (see below). - No use or stable use of antidepressants (i.e., a consistent dose of the same medication maintained for > 4 weeks with no plans to change). Exclusion Criteria: - Current or past light therapy or CBT for SAD. - Presence of a comorbid Axis I disorder that requires immediate treatment (i.e., bipolar disorder, psychotic disorders, substance use disorder). - Acute and serious suicidal intent. - Planned absences of >1 week from the area through March. - History of conditions that are known contra-indications to LT, including conditions associated with toxicity of bright light to the retina (i.e., macular degeneration or any retinopathy). | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Kelly Rohan，University of Vermont | ||
| 研究赞助商 ICMJE | University of Vermont | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | University of Vermont | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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