Nasstasia Yasmina, Baker Amanda L, Halpin Sean A, Hides Leanne, Lewin Terry J, Kelly Brian J, Callister Robin
School of Psychology, University of Newcastle, Callaghan, NSW 2308, Australia.
School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW 2308, Australia.
Contemp Clin Trials Commun. 2017 Nov 24;9:13-22. doi: 10.1016/j.conctc.2017.11.007. eCollection 2018 Mar.
Recent meta-analytic reviews suggest exercise can reduce depression severity among adults with major depressive disorder (MDD); however, efficacy studies with depressed youth are limited. Few studies have investigated the efficacy of multi-modal exercise interventions in this population, addressed treatment engagement, or explored the differential effects of exercise on depressive symptom profiles.
This paper describes the study protocol and recruitment pattern for an assessor blinded, two-arm randomised controlled trial investigating the efficacy of an integrated motivational interviewing (MI) and multi-modal exercise intervention in youth diagnosed with MDD. Associations between depressive symptom profiles (cognitive, somatic and affective) and psychological, physiological (fitness), and biological (blood biomarker) outcomes will also be examined.
Participants aged 15-25 years with current MDD were recruited. Eligible participants were randomised and stratified according to gender and depression severity to either an immediate or delayed (control) group. The immediate group received a brief MI intervention followed by a 12-week small group exercise intervention (3 times per week for 1 h), all delivered by personal trainers. The delayed control group received the same intervention 12-weeks later. Both groups were reassessed at mid-treatment or mid-control, post-treatment or post-control, and follow-up (12 weeks post-treatment).
68 participants were recruited and randomly allocated to an intervention group.
This trial will increase our understanding of the efficacy of multi-modal exercise interventions for depression and the specific effects of exercise on depressive symptom profiles. It also offers a novel contribution by addressing treatment engagement in exercise efficacy trials in youth with MDD.
近期的荟萃分析综述表明,运动可以减轻重度抑郁症(MDD)成年患者的抑郁严重程度;然而,针对抑郁青少年的疗效研究有限。很少有研究调查多模式运动干预对该人群的疗效、解决治疗参与度问题,或探讨运动对抑郁症状特征的不同影响。
本文描述了一项评估者盲法、双臂随机对照试验的研究方案和招募模式,该试验旨在研究综合动机访谈(MI)和多模式运动干预对诊断为MDD的青少年的疗效。还将研究抑郁症状特征(认知、躯体和情感)与心理、生理(体能)和生物学(血液生物标志物)结果之间的关联。
招募年龄在15 - 25岁、患有当前MDD的参与者。符合条件的参与者根据性别和抑郁严重程度随机分层,分为即刻干预组或延迟(对照)组。即刻干预组先接受简短的MI干预,随后进行为期12周的小组运动干预(每周3次,每次1小时),所有干预均由私人教练提供。延迟对照组在12周后接受相同的干预。两组在治疗中期或对照中期、治疗后或对照后以及随访(治疗后12周)时进行重新评估。
招募了68名参与者并随机分配到干预组。
该试验将增进我们对多模式运动干预治疗抑郁症疗效以及运动对抑郁症状特征具体影响的理解。它还通过解决患有MDD的青少年运动疗效试验中的治疗参与度问题,做出了新颖的贡献。