Clinical and cost-effectiveness of remote-delivered, online lifestyle therapy versus psychotherapy for reducing depression: results from the CALM non-inferiority, randomised trial

IF 7.6 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES The Lancet Regional Health: Western Pacific Pub Date : 2024-08-01 DOI:10.1016/j.lanwpc.2024.101142
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Abstract

Background

We conducted the first non-inferiority, randomised controlled trial to determine whether lifestyle therapy is non-inferior to psychotherapy with respect to mental health outcomes and costs when delivered via online videoconferencing.

Methods

An individually randomised, group treatment design with computer-generated block randomisation was used. Between May 2021–April 2022, 182 adults with a Distress Questionnaire-5 score = ≥8 (indicative depression) were recruited from a tertiary mental health service in regional Victoria, Australia and surrounds. Participants were assigned to six 90-min sessions over 8-weeks using group-based, online videoconferencing comprising: (1) lifestyle therapy (targeting nutrition, physical activity) with a dietitian and exercise physiologist (n = 91) or (2) psychotherapy (Cognitive Behavioural Therapy) with psychologists (n = 91). The primary outcome was Patient Health Questionnaire-9 (PHQ-9) depression at 8-weeks (non-inferiority margin ≤2) using Generalised Estimating Equations (GEE). Cost-minimisation analysis estimated the mean difference in total costs from health sector and societal perspectives. Outcomes were assessed by blinded research assistants using Computer Assisted Telephone Interviews. Results are presented per-protocol (PP) and Intention to Treat (ITT) using beta coefficients with 95% Confidence Intervals (CIs).

Findings

The sample was 80% women (mean: 45-years [SD:13.4], mean PHQ-9:10.5 [SD:5.7]. An average 4.2 of 6 sessions were completed, with complete data for n = 132. Over 8-weeks, depression reduced in both arms (PP: Lifestyle (n = 70) mean difference:−3.97, 95% CIs:−5.10, −2.84; and Psychotherapy (n = 62): mean difference:−3.74, 95% CIs:−5.12, −2.37; ITT: Lifestyle (n = 91) mean difference:−4.42, 95% CIs: −4.59, −4.25; Psychotherapy (n = 91) mean difference:−3.82, 95% CIs:−4.05, −3.69) with evidence of non-inferiority (PP GEE β:−0.59; 95% CIs:−1.87, 0.70, n = 132; ITT GEE β:−0.49, 95% CIs:−1.73, 0.75, n = 182). Three serious adverse events were recorded. While lifestyle therapy was delivered at lower cost, there were no differences in total costs (health sector adjusted mean difference: PP AUD$156 [95% CIs −$182, $611, ITT AUD$190 [95% CIs −$155, $651] ]; societal adjusted mean difference: PP AUD$350 [95% CIs:−$222, $1152] ITT AUD$ 408 [95% CIs −$139, $1157].

Interpretation

Remote-delivered lifestyle therapy was non-inferior to psychotherapy with respect to clinical and cost outcomes. If replicated in a fully powered RCT, this approach could increase access to allied health professionals who, with adequate training and guidelines, can deliver mental healthcare at comparable cost to psychologists.

Funding

This trial was funded by the Australian Medical Research Future Fund (GA133346) under its Covid-19 Mental Health Research Grant Scheme.

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远程在线生活方式疗法与心理疗法在减少抑郁方面的临床和成本效益对比:CALM 非劣效性随机试验的结果
背景我们开展了首个非劣效性随机对照试验,以确定通过在线视频会议提供的生活方式疗法在心理健康结果和成本方面是否不逊于心理疗法。2021年5月至2022年4月期间,从澳大利亚维多利亚州及其周边地区的一家三级心理健康服务机构招募了182名压力问卷-5得分=≥8(指示性抑郁)的成年人。参与者被分配到为期 8 周的 6 次 90 分钟疗程中,疗程采用基于小组的在线视频会议方式,包括:(1)由营养师和运动生理学家提供的生活方式疗法(针对营养和体育锻炼)(n = 91)或(2)由心理学家提供的心理疗法(认知行为疗法)(n = 91)。采用广义估计方程 (GEE),主要结果为 8 周时的患者健康问卷-9 (PHQ-9) 抑郁度(非劣效差≤2)。成本最小化分析从卫生部门和社会角度估算了总成本的平均差异。结果由盲人研究助理通过计算机辅助电话访谈进行评估。研究结果采用贝塔系数和 95% 置信区间 (CIs) 显示按方案 (PP) 和意向治疗 (ITT) 结果:45岁[SD:13.4],PHQ-9平均值:10.5[SD:5.7]。在 6 个疗程中,平均完成了 4.2 个疗程,有 132 人获得了完整的数据。在 8 周内,两组患者的抑郁程度均有所减轻(PP:生活方式(n = 70)平均差异:-3.97,95% CIs:-5.10,-2.84;心理疗法(n = 62):平均差异:-3.74,95% CIs:-5.12,-2.37;ITT:生活方式(n = 91)平均差异:-4.42,95% CIs:-4.59,-4.37):-4.59,-4.25;心理疗法(n = 91)平均差异:-3.82,95% CIs:-4.05,-3.69),有证据表明非劣效(PP GEE β:-0.59;95% CIs:-1.87,0.70,n = 132;ITT GEE β:-0.49,95% CIs:-1.73,0.75,n = 182)。共记录到三起严重不良事件。虽然生活方式疗法的成本较低,但总成本并无差异(卫生部门调整后的平均差异:PP 156 澳元 [95 CI:-0.49]):PP为156澳元[95% CIs为-182澳元,611澳元,ITT为190澳元[95% CIs为-155澳元,651澳元]];社会调整后的平均差异为350澳元[95% CIs为-182澳元,651澳元]:PP为350澳元[95% CIs:-222澳元,1152澳元] ITT为408澳元[95% CIs:-139澳元,1157澳元]。如果在完全有效的 RCT 中推广,这种方法可以增加专职医疗人员的使用机会,这些人员经过适当的培训和指导,可以以与心理学家相当的成本提供心理保健服务。
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来源期刊
The Lancet Regional Health: Western Pacific
The Lancet Regional Health: Western Pacific Medicine-Pediatrics, Perinatology and Child Health
CiteScore
8.80
自引率
2.80%
发文量
305
审稿时长
11 weeks
期刊介绍: The Lancet Regional Health – Western Pacific, a gold open access journal, is an integral part of The Lancet's global initiative advocating for healthcare quality and access worldwide. It aims to advance clinical practice and health policy in the Western Pacific region, contributing to enhanced health outcomes. The journal publishes high-quality original research shedding light on clinical practice and health policy in the region. It also includes reviews, commentaries, and opinion pieces covering diverse regional health topics, such as infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, aging health, mental health, the health workforce and systems, and health policy.
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