Patient outcomes and session dose in a randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction: Influential factors and methodological considerations

IF 4.3 2区心理学 Q1 PSYCHOLOGY, CLINICAL

Behaviour Research and Therapy Pub Date : 2026-04-01 Epub Date: 2026-02-17 DOI:10.1016/j.brat.2026.104987

Anne E. Milner , Laurel D. Sarfan , Marlen Diaz , Rafael Esteva Hache , Estephania Ovalle Patino , Allison G. Harvey

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引用次数: 0

Abstract

Objective

Randomized controlled trials (RCTs) assessing the implementation of evidence-based psychological treatments (EBPTs) into clinical practice may involve variations that are not always systematically investigated. This study aimed to investigate the impact of such variations in the context of an effectiveness-implementation hybrid trial - specifically, the relationship between trial outcomes and number of treatment sessions, dropout, and differences in assessment timing.

Method

Adults (N = 539) with sleep and circadian problems were randomized to the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC; Adapted or Standard version) or usual care followed by delayed treatment (UC-DT).

Results

Participants who completed the recommended number of TSC sessions showed larger effect sizes and more significant improvements relative to UC-DT, when compared to participants who received a partial session dose. Notably, a substantial number of participants who dropped out of treatment showed a meaningful clinical change by mid-treatment (20%), though this number did not differ significantly from the number of patients who received the full dose of treatment. Larger treatment effects were observed when assessments were completed within 3 months of their planned date. Kaplan-Meier Survival Analyses indicated that the dose to optimize the primary outcome of sleep disturbance at post-treatment was eight sessions for Standard TSC and six sessions for Adapted TSC.

Conclusions

This study underscores the impact of methodological variations on treatment outcomes in the implementation of TSC into clinical practice. Furthermore, our findings establish specific session thresholds for Standard and Adapted TSC to optimize clinical outcomes.

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睡眠和昼夜功能障碍的跨诊断干预的随机对照试验中的患者结局和疗程剂量：影响因素和方法学考虑。

目的：随机对照试验（rct）评估循证心理治疗（EBPTs）在临床实践中的实施可能涉及一些并不总是系统调查的变化。本研究旨在调查在有效性-实施混合试验背景下这些差异的影响，特别是试验结果与治疗次数、退出和评估时间差异之间的关系。方法：有睡眠和昼夜节律问题的成人（N = 539）被随机分配到睡眠和昼夜节律障碍的跨诊断干预（TSC；改编版或标准版）或常规护理后延迟治疗（UC-DT）。结果：与接受部分剂量的参与者相比，完成推荐数量的TSC会话的参与者相对于UC-DT显示出更大的效应大小和更显著的改善。值得注意的是，大量退出治疗的参与者在治疗中期表现出有意义的临床变化（20%），尽管这一数字与接受全剂量治疗的患者数量没有显着差异。当评估在计划日期的3个月内完成时，观察到更大的治疗效果。Kaplan-Meier生存分析显示，治疗后睡眠障碍主要结局的最佳剂量为标准TSC组8次，适应性TSC组6次。结论：本研究强调了在临床实践中实施TSC的方法变化对治疗结果的影响。此外，我们的研究结果为标准和适应TSC建立了特定的会话阈值，以优化临床结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Behaviour Research and Therapy PSYCHOLOGY, CLINICAL-

CiteScore

7.50

自引率

7.30%

发文量

148

期刊介绍： The major focus of Behaviour Research and Therapy is an experimental psychopathology approach to understanding emotional and behavioral disorders and their prevention and treatment, using cognitive, behavioral, and psychophysiological (including neural) methods and models. This includes laboratory-based experimental studies with healthy, at risk and subclinical individuals that inform clinical application as well as studies with clinically severe samples. The following types of submissions are encouraged: theoretical reviews of mechanisms that contribute to psychopathology and that offer new treatment targets; tests of novel, mechanistically focused psychological interventions, especially ones that include theory-driven or experimentally-derived predictors, moderators and mediators; and innovations in dissemination and implementation of evidence-based practices into clinical practice in psychology and associated fields, especially those that target underlying mechanisms or focus on novel approaches to treatment delivery. In addition to traditional psychological disorders, the scope of the journal includes behavioural medicine (e.g., chronic pain). The journal will not consider manuscripts dealing primarily with measurement, psychometric analyses, and personality assessment.