Arjadi Retha, Nauta Maaike H, Scholte Willem F, Hollon Steven D, Chowdhary Neerja, Suryani Angela O, Uiterwaal Cuno S P M, Bockting Claudi L H
Faculty of Psychology, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia; Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, Netherlands.
Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, Netherlands.
Lancet Psychiatry. 2018 Sep;5(9):707-716. doi: 10.1016/S2215-0366(18)30223-2. Epub 2018 Jul 11.
Depression is one of the leading contributors to the global burden of disease. However, treatment availability is often very poor in low-income and middle-income countries. In a randomised clinical trial, we investigated the efficacy of internet-based behavioural activation with lay counsellor support compared with online minimal psychoeducation without support for depression in Indonesia (a middle-income country).
We did a community-based, two-group, randomised controlled trial in Indonesia. Eligible participants were aged 16 years or older, scored 10 or above on the Patient Health Questionnaire 9 (PHQ-9), met the criteria for major depressive disorder or persistent depressive disorder based on the Structured Clinical Interview for DSM-5, were proficient in Bahasa Indonesia, and could use the internet. Participants were randomly allocated (1:1) by a research assistant using a web-based randomisation program to online behavioural activation with lay support (termed Guided Act and Feel Indonesia [GAF-ID]) or online psychoeducation without further support. Randomisation was done within a random permuted block design and was stratified by sex and depression severity (ie, PHQ-9 10-14 vs ≥15). The primary outcome was self-reported PHQ-9 score at 10 weeks from baseline. Research assistants were masked to group allocation until after the assessment of the primary outcome. Interventions were described to participants during the consent procedure and after randomisation, but no indication was given as to which was the intervention of interest and which was the control. Analysis was by intention to treat. The trial was registered in the Netherlands Trial Register, number NTR5920. It is closed to new particpants, and follow-up has been completed.
Between Sept 6, 2016, and May 1, 2017, 313 participants were enrolled and randomly assigned, 159 to the GAF-ID group and 154 to the online psychoeducation group. At 10 weeks, PHQ-9 scores were significantly lower in the GAF-ID group than in the online psychoeducation group (mean difference -1·26 points [95% CI -2·29 to -0·23]; p=0·017), and participants in the GAF-ID group had a 50% higher chance of remission at 10 weeks (relative risk 1·50 [95% CI 1·19 to 1·88]; p<0·0001). An effect size of 0·24 for the GAF-ID group compared with the control group at 10 weeks was sustained over time (effect size 0·24 at 3 months, and 0·27 at 6 months). No adverse events were reported in either group.
To our knowledge, ours is the first adequately powered randomised clinical trial of an internet-based intervention for depression in a low-income or middle-income country. Online behavioural activation with lay counsellor support efficaciously reduced symptoms of depression, and could help to bridge the mental health gap in low-income and middle-income countries.
Indonesia Endowment Fund for Education, University of Groningen.
抑郁症是全球疾病负担的主要成因之一。然而,在低收入和中等收入国家,抑郁症的治疗可及性往往非常低。在一项随机临床试验中,我们调查了在印度尼西亚(一个中等收入国家),基于互联网的行为激活疗法在非专业咨询师支持下与无支持的在线最低限度心理教育相比,治疗抑郁症的疗效。
我们在印度尼西亚开展了一项基于社区的两组随机对照试验。符合条件的参与者年龄在16岁及以上,患者健康问卷9(PHQ - 9)得分在10分及以上,根据DSM - 5结构化临床访谈符合重度抑郁症或持续性抑郁症的标准,精通印尼语,且会使用互联网。参与者由一名研究助理使用基于网络的随机化程序以1:1的比例随机分配到有非专业支持的在线行为激活疗法组(称为印尼引导行动与感受[GAF - ID])或无进一步支持的在线心理教育组。随机化采用随机排列区组设计,并按性别和抑郁严重程度分层(即PHQ - 9得分10 - 14分与≥15分)。主要结局是从基线起10周时自我报告的PHQ - 9得分。在主要结局评估完成之前,研究助理对分组情况不知情。在知情程序和随机化后向参与者描述了干预措施,但未表明哪项是感兴趣的干预措施,哪项是对照措施。分析采用意向性分析。该试验已在荷兰试验注册库注册,注册号为NTR5920。已停止招募新参与者,且随访已完成。
在2016年9月6日至2017年5月1日期间,共招募了313名参与者并随机分配,159名分配到GAF - ID组,154名分配到在线心理教育组。在10周时,GAF - ID组的PHQ - 9得分显著低于在线心理教育组(平均差值 - 1.26分[95%置信区间 - 2.29至 - 0.23];p = 0.017),且GAF - ID组的参与者在10周时缓解的可能性高50%(相对风险为1.50[95%置信区间1.19至1.88];p < 0.0001)。与对照组相比,GAF - ID组在10周时的效应量为0.24,且随时间持续存在(3个月时效应量为0.24,6个月时为0.27)。两组均未报告不良事件。
据我们所知,我们的研究是在低收入或中等收入国家进行的第一项有足够样本量的基于互联网的抑郁症干预随机临床试验。在非专业咨询师支持下的在线行为激活疗法有效减轻了抑郁症状,并有助于缩小低收入和中等收入国家的心理健康差距。
印度尼西亚教育捐赠基金、格罗宁根大学。