Therapist-guided and self-guided internet-based behavioural activation versus treatment as usual for adolescents with depression: randomised controlled trial with economic evaluation.

IF 6.6 0 PSYCHIATRY
Rebecca Andersson, Johan Ahlen, Fabian Lenhard, Anna Ohlis, Vera Wachtmeister, Moa Karemyr, Jens Högstrom, Matteo Bottai, David Mataix-Cols, Sarah Vigerland, Eva Serlachius
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引用次数: 0

Abstract

Background: Adolescent depression is a major public health concern with limited access to effective treatments. Behavioural activation (BA) is a suitable intervention for digital delivery, but definitive adolescent trials are scarce.

Objective: To evaluate whether therapist-guided and self-guided internet-based BA (I-BA) are more efficacious and cost-effective than treatment as usual (TAU) for adolescents with mild to moderate major depressive disorder (MDD).

Methods: Single-blinded, parallel-group randomised controlled trial with economic evaluation. A total of 219 adolescents (13-17 years) with mild-moderate MDD were randomised (1:1:1) to 10 weeks of therapist-guided I-BA, self-guided I-BA or TAU. Both I-BA interventions included adolescent and parent modules.

Primary outcome: change in depression severity (Children's Depression Rating Scale-Revised, CDRS-R, range 17-113) from baseline to 3-month follow-up (primary endpoint), assessed by blinded evaluators. Analyses included all randomised participants, with statisticians blinded to allocation. A health economic evaluation was performed at the primary endpoint.

Findings: Baseline CDRS-R indicated clinically significant depression (mean 57.1, threshold ≥40). Retention at the primary endpoint was 82.6%. Mean reductions were 17.0 (therapist-guided I-BA), 16.0 (self-guided I-BA) and 11.6 (TAU), bringing both I-BA groups below the clinical cut-off. Therapist-guided I-BA showed greater reductions than TAU (estimated mean difference -4.68; 95% CI -0.05 to -9.30; p=0.048, d=-0.47; 95% CI 0.00 to -0.93), while self-guided I-BA was not statistically superior (estimated mean difference -3.44; 95% CI -8.05 to 1.17, p=0.14, d=-0.37; 95% CI -0.86 to 0.12). The predefined six-point clinical important difference was not met. Results were sensitive to modelling: significance disappeared with random slopes but effect estimates were similar; baseline-adjusted analyses favoured both I-BA arms. Both I-BA options had lower costs than TAU (p=0.03, p<0.001), with self-guided I-BA being the most economical.

Conclusions: Therapist-guided I-BA reduced depressive symptoms at lower cost than TAU, but clinical importance and robustness are uncertain. Self-guided I-BA showed no clear superiority but was cost-efficient.

Clinical implications: Therapist-guided I-BA may increase access to evidence-based care for adolescents with MDD, though findings require cautious interpretation. Self-guided I-BA may be useful where therapist access is limited, but more research is needed.

治疗师指导和自我指导的基于互联网的行为激活与常规治疗青少年抑郁症:随机对照试验与经济评估。
背景:青少年抑郁症是一个主要的公共卫生问题,但获得有效治疗的机会有限。行为激活(BA)是一种适合于数字传输的干预措施,但明确的青少年试验很少。目的:评价治疗师指导和自我指导的基于互联网的BA (I-BA)治疗青少年轻中度重度抑郁障碍(MDD)是否比常规治疗(TAU)更有效和更具成本效益。方法:单盲、平行组随机对照试验,进行经济性评价。共有219名患有轻中度重度抑郁症的青少年(13-17岁)被随机分配(1:1:1)至10周的治疗师指导的I-BA、自我指导的I-BA或TAU。两种I-BA干预都包括青少年和家长模块。主要结局:抑郁严重程度的变化(儿童抑郁评定量表-修订,CDRS-R,范围17-113)从基线到3个月的随访(主要终点),由盲法评估者评估。分析包括所有随机参与者,统计学家对分配不知情。在主要终点进行健康经济评估。结果:基线CDRS-R显示临床显著抑郁(平均57.1,阈值≥40)。主要终点的保留率为82.6%。平均减少17.0(治疗师引导的I-BA), 16.0(自我引导的I-BA)和11.6 (TAU),使两组I-BA均低于临床临界值。治疗师引导的I-BA比TAU减少更多(估计平均差异为-4.68;95% CI为-0.05至-9.30;p=0.048, d=-0.47; 95% CI为0.00至-0.93),而自我引导的I-BA没有统计学上的优势(估计平均差异为-3.44;95% CI为-8.05至1.17,p=0.14, d=-0.37; 95% CI为-0.86至0.12)。未达到预定的6点临床重要差异。结果对建模很敏感:随机斜率显著性消失,但效果估计相似;基线调整后的分析均支持I-BA组。结论:治疗师指导下的I-BA治疗比TAU治疗减少抑郁症状的成本更低,但临床重要性和稳健性尚不确定。自导式I-BA没有明显的优势,但具有成本效益。临床意义:治疗师指导的I-BA可能会增加MDD青少年获得循证治疗的机会,尽管研究结果需要谨慎解释。自我引导的I-BA可能在治疗师接触有限的情况下有用,但需要更多的研究。
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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