O'Neil Adrienne, Perez Joahna, Young Lauren M, John Tayla, Turner Megan, Saunders Dean, Mahoney Sophie, Bryan Marita, Ashtree Deborah N, Jacka Felice N, Bruscella Courtney, Pilon Megan, Mohebbi Mohammadreza, Teychenne Megan, Rosenbaum Simon, Opie Rachelle, Hockey Meghan, Peric Lucija, De Araugo Samantha, Banker Khyati, Davids India, Tembo Monica, Davis Jessica A, Lai Jerry, Rocks Tetyana, O'Shea Melissa, Mundell Niamh L, McKeon Grace, Yucel Murat, Absetz Pilvikki, Versace Vincent, Manger Sam, Morgan Mark, Chapman Anna, Bennett Craig, Speight Jane, Berk Michael, Moylan Steve, Radovic Lara, Chatterton Mary Lou
Deakin University, IMPACT - the Institute for Mental and Physical Health and Clinical Translation, Food & Mood Centre, School of Medicine, Barwon Health, Geelong, Australia.
Monash University, Melbourne, Victoria, Australia.
Lancet Reg Health West Pac. 2024 Jul 31;49:101142. doi: 10.1016/j.lanwpc.2024.101142. eCollection 2024 Aug.
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.
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).
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].
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.
This trial was funded by the Australian Medical Research Future Fund (GA133346) under its Covid-19 Mental Health Research Grant Scheme.
我们开展了第一项非劣效性随机对照试验，以确定通过在线视频会议提供生活方式疗法在心理健康结果和成本方面是否不劣于心理治疗。
采用计算机生成的区组随机化进行个体随机分组治疗设计。2021年5月至2022年4月期间，从澳大利亚维多利亚州及周边地区的一家三级心理健康服务机构招募了182名苦恼问卷-5得分≥8（提示抑郁）的成年人。参与者通过基于小组的在线视频会议，在8周内参加六次90分钟的课程，内容包括：（1）由营养师和运动生理学家进行的生活方式疗法（针对营养、体育活动）（n = 91），或（2）由心理学家进行的心理治疗（认知行为疗法）（n = 91）。主要结局是使用广义估计方程（GEE）在8周时的患者健康问卷-9（PHQ-9）抑郁评分（非劣效性边际≤2）。成本最小化分析从卫生部门和社会角度估计总成本的平均差异。结局由盲法研究助理通过计算机辅助电话访谈进行评估。结果按符合方案集（PP）和意向性分析（ITT）呈现，使用带有95%置信区间（CI）的β系数。
样本中80%为女性（平均年龄：45岁[标准差：13.4]，平均PHQ-9评分：10.5[标准差：5.7]）。平均6次课程中完成了4.2次，132例有完整数据。在8周内，两组的抑郁症状均有所减轻（PP：生活方式疗法组（n = 70）平均差异：-3.97，95%CI：-5.10，-2.84；心理治疗组（n = 62）：平均差异：-3.74，95%CI：-5.12，-2.37；ITT：生活方式疗法组（n = 91）平均差异：-4.42，95%CI：-4.59，-4.25；心理治疗组（n = 91）平均差异：-3.82，95%CI：-4.05，-3.69），有非劣效性证据（PP GEE β：-0.59；95%CI：-1.87，0.70，n = 132；ITT GEE β：-0.49，95%CI：-1.73，0.75，n = 182）。记录到三起严重不良事件。虽然生活方式疗法的成本较低，但总成本没有差异（卫生部门调整后的平均差异：PP澳元156[95%CI：-182，611澳元，ITT澳元190[95%CI：-155，651澳元]；社会调整后的平均差异：PP澳元350[95%CI：-222，1152澳元]，ITT澳元408[95%CI：-139，1157澳元]）。
在临床和成本结局方面，远程提供的生活方式疗法不劣于心理治疗。如果在一项充分有力的随机对照试验中得到重复验证，这种方法可以增加获得相关健康专业人员服务的机会，这些人员经过适当培训并遵循指南，能够以与心理学家相当的成本提供心理保健服务。
本试验由澳大利亚医学研究未来基金（GA133346）根据其新冠疫情心理健康研究资助计划提供资金。
Zotero 插件
