Kallesøe Karen Hansen, Schröder Andreas, Wicksell Rikard K, Fink Per, Ørnbøl Eva, Rask Charlotte Ulrikka
Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
Behavior Medicine Pain Treatment Services, Karolinska, Stockholm, Sweden.
BMJ Open. 2016 Sep 15;6(9):e012743. doi: 10.1136/bmjopen-2016-012743.
Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS).
A total of 120 adolescents aged 15-19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility.
The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals.
This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS.
NCT02346071; Pre-results.
功能性躯体综合征（FSS）在青少年中很常见，其特征是严重残疾和生活质量下降。行为疗法，如接纳与承诺疗法（ACT），在患有FSS的儿童和青少年中已显示出有前景的结果，但一直专注于特定综合征，如功能性疼痛。本研究将比较基于团体的ACT与强化常规护理（EUC）对一系列FSS青少年的疗效，这些FSS通过多器官身体困扰综合征（BDS）这一统一概念来实施。
总共120名年龄在15 - 19岁且被诊断为多器官BDS、病程至少12个月的青少年将接受评估并随机分为：（1）EUC：与儿童和青少年精神科医生进行的手册化咨询及个体化治疗计划；或（2）基于ACT的手册化团体治疗加EUC。ACT项目包括9个模块（即27小时）和1次随访会议（3小时）。主要结局是身体健康，通过随机分组后12个月的简短健康调查问卷（SF - 36）总分来评估。次要结局包括自我报告的症状严重程度、症状干扰、抑郁和焦虑、疾病担忧、感知压力和总体改善情况；以及通过心率变异性、头发皮质醇和炎症生物标志物测量的客观身体活动和身体应激反应。过程指标是疾病认知、疾病相关行为和心理灵活性。
本研究按照《赫尔辛基宣言II》进行。已获得丹麦中部地区科学伦理委员会和丹麦数据保护机构的批准。研究结果将力求根据CONSORT声明在同行评审期刊上发表。
这是首批较大规模的随机临床试验之一，评估基于团体的干预对一系列严重FSS青少年的效果。
NCT02346071；预结果。
