Department of Psychiatry, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1230, New York, NY, 10029, USA.
MIRECC, James J. Peters VA Medical Center, Bronx, NY, USA.
Trials. 2020 Oct 21;21(1):871. doi: 10.1186/s13063-020-04788-z.
Suicide risk among individuals with schizophrenia (SZ) is intractably high, with over 40% of individuals attempting to take their own lives during their lifetime and an estimated 5-10% completing suicide. At present, available pharmacological and psychotherapeutic treatments offer limited risk reduction benefits, and thus, there remains an urgent need to explore novel interventions that will ameliorate this risk. Aerobic exercise (AE) has been shown to improve a number of predictors of suicide risk (e.g., depressed mood, sleeping difficulties). As individuals with SZ display a highly sedentary lifestyle, AE may reduce suicide risk.
Employing a multi-site, single-blind, randomized clinical trial design, we will examine the impact of AE on risk for suicide and related variables in individuals with SZ. Participants will be randomized to one of two 12-week exercise interventions: AE or a stretching and toning (ST) control intervention. Primary outcome measures will include suicide risk (Columbia Suicide Severity Rating Scale, C-SSRS) and aerobic fitness (VOmax), along with additional measures of suicide risk, mood, emotion regulation, sleep, cognition, and physical activity, with assessments completed at baseline and after 6 and 12 weeks of interventions.
It is hypothesized that AE will reduce suicide risk among individuals with SZ. This study may offer support for a more efficacious treatment method for this population in addition to the pre-existing pharmacological and psychotherapeutic treatment regimens.
Clinicaltrials.gov, NCT03270098 . Registered on September 1, 2017.
精神分裂症患者（SZ）的自杀风险极高，超过 40%的个体在一生中试图自杀，估计有 5-10%的个体完成自杀。目前，可用的药物和心理治疗方法提供的风险降低益处有限，因此，迫切需要探索新的干预措施来降低这种风险。有氧运动（AE）已被证明可以改善许多自杀风险的预测因素（例如，抑郁情绪、睡眠困难）。由于 SZ 患者的生活方式高度久坐不动，AE 可能会降低自杀风险。
采用多中心、单盲、随机临床试验设计，我们将研究 AE 对 SZ 患者自杀风险及相关变量的影响。参与者将随机分为两种 12 周的运动干预组之一：AE 或拉伸和塑形（ST）对照干预组。主要结局指标将包括自杀风险（哥伦比亚自杀严重程度评定量表，C-SSRS）和有氧运动能力（VOmax），以及自杀风险、情绪、情绪调节、睡眠、认知和身体活动的其他测量指标，评估在基线和干预 6 周和 12 周后完成。
假设 AE 将降低 SZ 患者的自杀风险。这项研究可能为这一人群提供除现有药物和心理治疗方案之外的更有效的治疗方法。
Clinicaltrials.gov，NCT03270098。于 2017 年 9 月 1 日注册。
