Elucidating treatment targets and mediators within a confirmatory efficacy trial: study protocol for a randomized controlled trial of cognitive-behavioral therapy vs. light therapy for winter depression.
Elucidating treatment targets and mediators within a confirmatory efficacy trial: study protocol for a randomized controlled trial of cognitive-behavioral therapy vs. light therapy for winter depression.
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DOI：
10.1186/s13063-022-06330-9
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发表时间：
2022-05-12
期刊：
影响因子：
2.5
通讯作者：
Vacek, Pamela M.
中科院分区：
文献类型：
--
作者：
Rohan, Kelly J.;Franzen, Peter L.;Roeckelin, Kathryn A.;Siegle, Greg J.;Kolko, David J.;Postolache, Teodor T.;Vacek, Pamela M.
关键词：
本研究是针对冬季季节性情感障碍（SAD）的两种治疗方法：针对SAD的群体认知行为疗法（CBT-SAD）和光疗法（LT）的验证性疗效试验。在我们之前的疗效试验中，CBT-SAD和LT的治疗后结果非常相似，但CBT-SAD比LT晚两个冬天的抑郁症复发率更低（CBT-SAD为27.3%，LT为45.6%）。CBT-SAD参与并改变了一种特定的作用机制，即季节性信念，它介导了CBT-SAD的急性抗抑郁作用和CBT-SAD对LT的持久益处。从理论上讲，季节性信念不同于LT假设的目标和机制：纠正昼夜节律阶段。本研究采用实验治疗方法来确定每种治疗方法在有效时是如何起作用的，并确定每种治疗方法的最佳候选者。LT的目标和效果的生物标志物包括昼夜相角差和照明后瞳孔反应。CBT-SAD的目标和效果的生物标志物包括瞳孔和持续额叶伽玛波段脑电图对季节性词汇的反应减少，这被假设为季节性信念的生物标志物，反映了CBT-SAD后对季节性刺激的参与减少。除了确定变化机制外，本研究还测试了复发时“切换”决策规则的有效性，以指导临床决策。患有SAD的成人（目标N = 160）将在冬季1随机分为6周的CBT-SAD或LT；其次是冬季；并且，如果抑郁症复发，提供交叉治疗（即从低剂量治疗转为低剂量治疗或低剂量治疗转为低剂量治疗）。所有受试者将在冬季进行随访。生物标志物评估发生在冬季1的治疗前、治疗中和治疗后，冬季2的随访（对于交叉的患者，在治疗中/治疗后再次进行）和冬季3的随访。主要疗效分析将检验CBT-SAD在抑郁症复发状态上优于LT（主要结局）。中介分析将使用平行过程潜在增长曲线模型。与国家精神卫生研究所在研究领域标准相关生物标志物水平上展示目标参与的优先事项一致，本工作旨在确认LT和CBT-SAD的目标和机制，以最大限度地提高未来传播工作的影响。ClinicalTrials.gov识别码：NCT03691792。2018年10月2日注册。
This study is a confirmatory efficacy trial of two treatments for winter seasonal affective disorder (SAD): SAD-tailored group cognitive-behavioral therapy (CBT-SAD) and light therapy (LT). In our previous efficacy trial, post-treatment outcomes for CBT-SAD and LT were very similar, but CBT-SAD was associated with fewer depression recurrences two winters later 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 mediated CBT-SAD’s acute antidepressant effects and CBT-SAD’s enduring benefit over LT. Seasonal beliefs are theoretically distinct from LT’s assumed target and mechanism: correction of circadian phase. This study applies the experimental therapeutics approach to determine how each treatment works when it is effective and to identify the best candidates for each. Biomarkers of LT’s target and effect include circadian phase angle difference and the post-illumination pupil response. Biomarkers of CBT-SAD’s target and effect include decreased pupillary and sustained frontal gamma-band EEG responses to seasonal words, which are hypothesized as biomarkers of seasonal beliefs, reflecting less engagement with seasonal stimuli following CBT-SAD. In addition to determining change mechanisms, this study tests the efficacy of a “switch” decision rule upon recurrence to inform clinical decision-making in practice. Adults with SAD (target N = 160) will be randomzied to 6-weeks of CBT-SAD or LT in winter 1; followed in winter 2; and, if a depression recurrence occurs, offered cross-over into the alternate treatment (i.e., switch from LT➔CBT-SAD or CBT-SAD➔LT). All subjects will be followed in winter 3. Biomarker assessments occur at pre-, mid-, and post-treatment in winter 1, at winter 2 follow-up (and again at mid-/post-treatment for those crossed-over), and at winter 3 follow-up. Primary efficacy analyses will test superiority of CBT-SAD over LT on depression recurrence status (the primary outcome). Mediation analyses will use parallel process latent growth curve modeling. Consistent with the National Institute of Mental Health’s priorities for demonstrating target engagement at the level of Research Domain Criteria-relevant biomarkers, this work aims to confirm the targets and mechanisms of LT and CBT-SAD to maximize the impact of future dissemination efforts. ClinicalTrials.gov identifier: NCT03691792. Registered on October 2, 2018.
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DOI：
10.1177/070674379704200309
发表时间：
1997-04-01
影响因子：
4
作者：
Lam, RW;Levitan, RD;Lamoureux, S
通讯作者：
Lamoureux, S
影响因子：
6.6
作者：
Ghadirian, AM;Murphy, BEP;Gendron, MJ
通讯作者：
Gendron, MJ
影响因子：
3.6
作者：
Rohan KJ;Meyerhoff J;Roecklein KA;DeSarno MJ;Vacek PM
通讯作者：
Vacek PM
影响因子：
4.2
作者：
Kerr, Margee;Siegle, Greg J.;Orsini, Jahala
通讯作者：
Orsini, Jahala
影响因子：
1.8
作者：
Gamlin, Paul D. R.;McDougal, David H.;Dacey, Dennis M.
通讯作者：
Dacey, Dennis M.