Department of Adolescent Psychiatry, Helsinki University Hospital, Helsinki, Finland; Clinicum, Department of Public Health, University of Helsinki, Helsinki, Finland.
Department of Biostatistics, University of Turku, Turku, Finland.
J Affect Disord. 2021 May 1;286:228-238. doi: 10.1016/j.jad.2021.02.007. Epub 2021 Feb 5.
Meru Health Program (MHP) is a therapist-guided, 8-week intervention for depression delivered via smartphone. The aim was to test its efficacy in patients with clinical depression in a Finnish university student health service.
Patients (n=124, women 72.6%, mean age 25y) were stratified based on antidepressant status, and randomized into intervention group receiving MHP plus treatment as usual (TAU), and control group receiving TAU only. Depression, measured by the Patient Health Questionnaire-9 (PHQ-9) scale, was the primary outcome. After baseline (T0), follow-ups were at mid-intervention (T4), immediately post-intervention (T8); 3 months (T20), and 6 months (T32) post-intervention.
The intervention group and control group did not have significant differences in depression outcomes throughout end of treatment and follow-up. Among secondary outcomes, increase in resilience (d=0.32, p=0.03) and mindfulness (d=0.57, p=0.002), and reduction in perceived stress (d=-0.52, p=0.008) were greater in MHP+TAU versus TAU at T32; no differences were found in anxiety, sleep disturbances, and quality of life between groups. Post-hoc comparisons of patients on antidepressants showed significantly greater reduction in depression at T32 for MHP+TAU versus TAU (d=-0.73, p=0.01); patients not on antidepressants showed no between-group differences.
Limitations include unknown characteristics of TAU, potential bias from patients and providers not being blinded to treatment group, and failure to specify examination of differences by antidepressant status in the protocol.
Most outcomes, including depression, did not significantly differ between MHP+TAU and TAU. Exploratory analysis revealed intervention effect at the end of the 6-month follow-up among patients on antidepressant medication.
梅鲁健康计划（MHP）是一种由治疗师指导的、为期 8 周的智能手机抑郁症干预措施。其目的是在芬兰大学生健康服务中检验其对临床抑郁症患者的疗效。
根据抗抑郁药物的使用情况，将患者（n=124，女性 72.6%，平均年龄 25 岁）分层，随机分为接受 MHP 和常规治疗（TAU）的干预组和仅接受 TAU 的对照组。以患者健康问卷-9（PHQ-9）量表评估的抑郁程度为主要结局。在基线（T0）后，在干预中期（T4）、干预结束时（T8）、3 个月（T20）和 6 个月（T32）进行随访。
干预组和对照组在治疗结束和随访期间的抑郁结局均无显著差异。在次要结局中，MHP+TAU 组在 T32 时的韧性（d=0.32，p=0.03）和正念（d=0.57，p=0.002）增加，以及感知压力（d=-0.52，p=0.008）降低的幅度大于 TAU 组；两组在焦虑、睡眠障碍和生活质量方面均无差异。对于服用抗抑郁药的患者，MHP+TAU 组在 T32 时的抑郁程度显著低于 TAU 组（d=-0.73，p=0.01）；未服用抗抑郁药的患者组间无差异。
局限性包括对 TAU 未知的特征、患者和提供者对治疗组不设盲法可能产生的偏倚，以及方案中未具体说明按抗抑郁药状态检查差异。
大多数结局，包括抑郁，MHP+TAU 组和 TAU 组之间没有显著差异。探索性分析显示，在服用抗抑郁药的患者中，在 6 个月随访结束时存在干预效果。
