Papola Davide, Purgato Marianna, Gastaldon Chiara, Bovo Chiara, van Ommeren Mark, Barbui Corrado, Tol Wietse A
Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
Cochrane Global Mental Health, University of Verona, Verona, Italy.
Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD012417. doi: 10.1002/14651858.CD012417.pub2.
People living in 'humanitarian settings' in low- and middle-income countries (LMICs) are exposed to a constellation of physical and psychological stressors that make them vulnerable to developing mental disorders. A range of psychological and social interventions have been implemented with the aim to prevent the onset of mental disorders and/or lower psychological distress in populations at risk, and it is not known whether interventions are effective.
To compare the efficacy and acceptability of psychological and social interventions versus control conditions (wait list, treatment as usual, attention placebo, psychological placebo, or no treatment) aimed at preventing the onset of non-psychotic mental disorders in people living in LMICs affected by humanitarian crises.
We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR), the Cochrane Drugs and Alcohol Review Group (CDAG) Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), Embase (OVID), PsycINFO (OVID), and ProQuest PILOTS database with results incorporated from searches to February 2020. We also searched the World Health Organization's (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to identify unpublished or ongoing studies. We checked the reference lists of relevant studies and reviews.
All randomised controlled trials (RCTs) comparing psychological and social interventions versus control conditions to prevent the onset of mental disorders in adults and children living in LMICs affected by humanitarian crises. We excluded studies that enrolled participants based on a positive diagnosis of mental disorder (or based on a proxy of scoring above a cut-off score on a screening measure).
We calculated standardised mean differences for continuous outcomes and risk ratios for dichotomous data, using a random-effects model. We analysed data at endpoint (zero to four weeks after therapy) and at medium term (one to four months after intervention). No data were available at long term (six months or longer). We used GRADE to assess the quality of evidence.
In the present review we included seven RCTs with a total of 2398 participants, coming from both children/adolescents (five RCTs), and adults (two RCTs). Together, the seven RCTs compared six different psychosocial interventions against a control comparator (waiting list in all studies). All the interventions were delivered by paraprofessionals and, with the exception of one study, delivered at a group level. None of the included studies provided data on the efficacy of interventions to prevent the onset of mental disorders (incidence). For the primary outcome of acceptability, there may be no evidence of a difference between psychological and social interventions and control at endpoint for children and adolescents (RR 0.93, 95% CI 0.78 to 1.10; 5 studies, 1372 participants; low-quality evidence) or adults (RR 0.96, 95% CI 0.61 to 1.50; 2 studies, 767 participants; very low quality evidence). No information on adverse events related to the interventions was available. For children's and adolescents' secondary outcomes of prevention interventions, there may be no evidence of a difference between psychological and social intervention groups and control groups for reducing PTSD symptoms (standardised mean difference (SMD) -0.16, 95% CI -0.50 to 0.18; 3 studies, 590 participants; very low quality evidence), depressive symptoms (SMD -0.01, 95% CI -0.29 to 0.31; 4 RCTs, 746 participants; very low quality evidence) and anxiety symptoms (SMD 0.11, 95% CI -0.09 to 0.31; 3 studies, 632 participants; very low quality evidence) at study endpoint. In adults' secondary outcomes of prevention interventions, psychological counselling may be effective for reducing depressive symptoms (MD -7.50, 95% CI -9.19 to -5.81; 1 study, 258 participants; very low quality evidence) and anxiety symptoms (MD -6.10, 95% CI -7.57 to -4.63; 1 study, 258 participants; very low quality evidence) at endpoint. No data were available for PTSD symptoms in the adult population. Owing to the small number of RCTs included in the present review, it was not possible to carry out neither sensitivity nor subgroup analyses.
AUTHORS' CONCLUSIONS: Of the seven prevention studies included in this review, none assessed whether prevention interventions reduced the incidence of mental disorders and there may be no evidence for any differences in acceptability. Additionally, for both child and adolescent populations and adult populations, a very small number of RCTs with low quality evidence on the review's secondary outcomes (changes in symptomatology at endpoint) did not suggest any beneficial effect for the studied prevention interventions. Confidence in the findings is hampered by the scarcity of prevention studies eligible for inclusion in the review, by risk of bias in the studies, and by substantial levels of heterogeneity. Moreover, it is possible that random error had a role in distorting results, and that a more thorough picture of the efficacy of prevention interventions will be provided by future studies. For this reason, prevention studies are urgently needed to assess the impact of interventions on the incidence of mental disorders in children and adults, with extended periods of follow-up.
生活在低收入和中等收入国家(LMICs)“人道主义环境”中的人们面临一系列生理和心理压力源,这使他们易患精神障碍。为预防精神障碍的发生和/或减轻高危人群的心理困扰,已实施了一系列心理和社会干预措施,但尚不清楚这些干预措施是否有效。
比较心理和社会干预措施与对照条件(等待名单、常规治疗、注意力安慰剂、心理安慰剂或不治疗)在预防受人道主义危机影响的LMICs人群非精神病性精神障碍发生方面的疗效和可接受性。
我们检索了Cochrane常见精神障碍对照试验注册库(CCMD - CTR)、Cochrane药物与酒精审查小组(CDAG)专业注册库、Cochrane对照试验中央注册库(CENTRAL)、MEDLINE(OVID)、Embase(OVID)、PsycINFO(OVID)和ProQuest PILOTS数据库,纳入截至2020年2月检索结果。我们还检索了世界卫生组织(WHO)国际临床试验注册平台和ClinicalTrials.gov以识别未发表或正在进行的研究。我们检查了相关研究和综述的参考文献列表。
所有比较心理和社会干预措施与对照条件以预防受人道主义危机影响的LMICs儿童和成人精神障碍发生的随机对照试验(RCTs)。我们排除了基于精神障碍阳性诊断(或基于筛查测量中高于临界分数的代理评分)招募参与者的研究。
我们使用随机效应模型计算连续结局的标准化均值差和二分数据的风险比。我们在终点(治疗后零至四周)和中期(干预后一至四个月)分析数据。长期(六个月或更长时间)无可用数据。我们使用GRADE评估证据质量。
在本综述中,我们纳入了7项RCTs,共2398名参与者,来自儿童/青少年(5项RCTs)和成人(2项RCTs)。这7项RCTs共比较了6种不同的心理社会干预措施与对照比较组(所有研究均为等待名单)。所有干预措施均由非专业人员实施,除一项研究外,均以小组形式进行。纳入的研究均未提供关于干预措施预防精神障碍发生(发病率)疗效的数据。对于可接受性的主要结局,在终点时,儿童和青少年(风险比0.93,95%置信区间0.78至1.10;5项研究,1372名参与者;低质量证据)或成人(风险比0.96,95%置信区间0.61至1.50;2项研究,767名参与者;极低质量证据)的心理和社会干预措施与对照之间可能没有差异的证据。没有关于与干预措施相关不良事件的信息。对于儿童和青少年预防干预措施的次要结局,在研究终点时,心理和社会干预组与对照组在减轻创伤后应激障碍症状(标准化均值差(SMD) - 0.16,95%置信区间 - 0.50至0.18;3项研究,590名参与者;极低质量证据)、抑郁症状(SMD - 0.01,95%置信区间 - 0.29至0.31;4项RCTs,746名参与者;极低质量证据)和焦虑症状(SMD 0.11,95%置信区间 - 0.09至0.31;3项研究,632名参与者;极低质量证据)方面可能没有差异的证据。在成人预防干预措施的次要结局中,心理辅导在终点时可能对减轻抑郁症状(平均差 - 7.50,95%置信区间 - 9.19至 - 5.81;1项研究,258名参与者;极低质量证据)和焦虑症状(平均差 - 6.10,95%置信区间 - 7.57至 - 4.63;1项研究,258名参与者;极低质量证据)有效。成人人群中创伤后应激障碍症状无可用数据。由于本综述纳入的RCTs数量较少,无法进行敏感性分析和亚组分析。
在本综述纳入的7项预防研究中,没有一项评估预防干预措施是否降低了精神障碍的发病率,并且在可接受性方面可能没有差异的证据。此外,对于儿童和青少年人群以及成人人群,关于综述次要结局(终点时症状学变化)的RCTs数量极少且证据质量低,未显示所研究的预防干预措施有任何有益效果。纳入综述的预防研究稀缺、研究存在偏倚风险以及大量的异质性阻碍了对研究结果的信心。此外,随机误差可能在扭曲结果方面起了作用,未来的研究可能会提供关于预防干预措施疗效更全面的情况。因此,迫切需要进行预防研究,以评估干预措施对儿童和成人精神障碍发病率的影响,并进行更长时间的随访。