The effectiveness of SPARX, a computerised self help intervention for adolescents seeking help for depression: randomised controlled non-inferiority trial.
The effectiveness of SPARX, a computerised self help intervention for adolescents seeking help for depression: randomised controlled non-inferiority trial.
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DOI：
10.1136/bmj.e2598
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发表时间：
2012-04-18
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影响因子：
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通讯作者：
Lucassen MF
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作者：
Merry SN;Stasiak K;Shepherd M;Frampton C;Fleming T;Lucassen MF
目的评估一种新的计算机化认知行为治疗干预（SPARX，Smart，Positive，Active，Realistic，X-factor thoughts）是否能减少寻求帮助的青少年的抑郁症状。设计多中心随机对照非劣效性试验。在新西兰设立24个初级保健站（青年诊所、全科诊所和学校咨询服务）。参与者187名12-19岁的青少年，寻求抑郁症状的帮助，没有自我伤害的重大风险，并被认为需要由他们的初级保健医生治疗：94人被分配到SPARX，93人照常治疗。干预措施计算机化认知行为疗法（SPARX）包括在四至七周的时间内提供的七个模块，而通常的治疗主要包括由训练有素的顾问和临床心理学家提供的面对面咨询。结果：主要结果是儿童抑郁评定量表（修订版）评分的变化。次要结果包括儿童抑郁量表修订版的反应和缓解，Reynolds青少年抑郁量表第二版的变化评分，情绪和感觉问卷，Kazdin儿童绝望量表，Spence儿童焦虑量表，儿科生活质量享受和满意度问卷，以及对治疗评分的总体满意度。结果94名参与者被分配到SPARX组（平均年龄15.6岁，62.8%女性），93名参与者被分配到常规治疗组（平均年龄15.6岁，68.8%女性）。170名青少年（91%，SPARX n=85，常规治疗n=85）在干预后接受了评估，168名（90%，SPARX n=83，常规治疗n=85）在3个月随访时接受了评估。符合方案分析（n=143）显示SPARX不劣于常规治疗。干预后，SPARX组和常规治疗组儿童抑郁评定量表修订版原始评分平均降低10.32分和7.59分（组间差异2.73，95%置信区间-0.31至5.77; P=0.079）。SPARX组的缓解率显著较高（n=31，43.7%）比常规治疗组（n=19，26.4%）（差异17.3%，95%可信区间1.6%~ 31.8%; P=0.030），SPARX组之间的缓解率无显著差异（66.2%，n=47）和常规治疗组（58.3%，n=42）（差异7.9%，-7.9%至24%; P=0.332）。所有次要指标均支持非劣效性。意向治疗分析证实了这些发现。随访时保持改善。两组之间归类为“可能”或“很可能”与干预相关的不良事件的频率没有差异（SPARX n=11;常规治疗n=11）。结论SPARX是一种潜在的替代常规护理的青少年抑郁症状在初级保健设置，并可用于解决一些未满足的治疗需求。试验注册澳大利亚新西兰临床试验ACTRN 12609000249257。
Objective To evaluate whether a new computerised cognitive behavioural therapy intervention (SPARX, Smart, Positive, Active, Realistic, X-factor thoughts) could reduce depressive symptoms in help seeking adolescents as much or more than treatment as usual. Design Multicentre randomised controlled non-inferiority trial. Setting 24 primary healthcare sites in New Zealand (youth clinics, general practices, and school based counselling services). Participants 187 adolescents aged 12-19, seeking help for depressive symptoms, with no major risk of self harm and deemed in need of treatment by their primary healthcare clinicians: 94 were allocated to SPARX and 93 to treatment as usual. Interventions Computerised cognitive behavioural therapy (SPARX) comprising seven modules delivered over a period of between four and seven weeks, versus treatment as usual comprising primarily face to face counselling delivered by trained counsellors and clinical psychologists. Outcomes The primary outcome was the change in score on the children’s depression rating scale-revised. Secondary outcomes included response and remission on the children’s depression rating scale-revised, change scores on the Reynolds adolescent depression scale-second edition, the mood and feelings questionnaire, the Kazdin hopelessness scale for children, the Spence children’s anxiety scale, the paediatric quality of life enjoyment and satisfaction questionnaire, and overall satisfaction with treatment ratings. Results 94 participants were allocated to SPARX (mean age 15.6 years, 62.8% female) and 93 to treatment as usual (mean age 15.6 years, 68.8% female). 170 adolescents (91%, SPARX n=85, treatment as usual n=85) were assessed after intervention and 168 (90%, SPARX n=83, treatment as usual n=85) were assessed at the three month follow-up point. Per protocol analyses (n=143) showed that SPARX was not inferior to treatment as usual. Post-intervention, there was a mean reduction of 10.32 in SPARX and 7.59 in treatment as usual in raw scores on the children’s depression rating scale-revised (between group difference 2.73, 95% confidence interval −0.31 to 5.77; P=0.079). Remission rates were significantly higher in the SPARX arm (n=31, 43.7%) than in the treatment as usual arm (n=19, 26.4%) (difference 17.3%, 95% confidence interval 1.6% to 31.8%; P=0.030) and response rates did not differ significantly between the SPARX arm (66.2%, n=47) and treatment as usual arm (58.3%, n=42) (difference 7.9%, −7.9% to 24%; P=0.332). All secondary measures supported non-inferiority. Intention to treat analyses confirmed these findings. Improvements were maintained at follow-up. The frequency of adverse events classified as “possibly” or “probably” related to the intervention did not differ between groups (SPARX n=11; treatment as usual n=11). Conclusions SPARX is a potential alternative to usual care for adolescents presenting with depressive symptoms in primary care settings and could be used to address some of the unmet demand for treatment. Trial registration Australian New Zealand Clinical Trials ACTRN12609000249257.