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Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples

机译:增强抑郁症中的社交互动(SIDE研究):一项基于认知的同情训练对夫妇的影响的随机对照试验的方案

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Introduction Positive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners’ health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient’s neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of “Cognitively Based Compassion Training (CBCT?)”. However, randomised trials are still scarce. Previous programmes did not involve participation of the patient’s romantic partner. Therefore, the present study aims to investigate whether a CBCT? programme adapted for couples (CBCT?-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress.Methods and analysis Couples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10?week CBCT?-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, α-amylase, interleukin (IL)-1?/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy.Ethics and dissemination Ethical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry.Trial registration number NCT03080025.
机译:简介积极的社会互动(PSI)和稳定的人际关系可以对健康产生实质性的好处。但是,患有抑郁症的患者受益于这些促进健康的作用。此外,人们发现,抑郁症状会严重影响人际关系的质量,甚至伴侣的健康,这可能会导致浪漫情侣的社交功能全面受损。心理生物学研究表明,这些损伤可能伴有患者对外部应激源的神经内分泌反应的不良适应性调节。关于社会功能的改善,最初的研究显示了“基于认知的同情训练(CBCT?)”的可喜结果。但是,仍然缺乏随机试验。以前的计划没有涉及患者浪漫伴侣的参与。因此,本研究旨在调查是否存在CBCT?方法和分析适用于夫妇的程序(CBCT?-fC)可以改善抑郁症状,困扰,社交互动技能和压力的神经生物学调节。方法和分析将邀请患有抑郁症的女性伴侣参加事前调查连续两天的干预评估,分别涉及标准化的PSI任务,眼动仪,心电图记录,唾液采样,血液采样和问卷数据。在进行基线评估后,参与研究的夫妇将被随机分为10周CBCTα-fC或常规控制条件下的治疗。主要终点是通过汉密尔顿抑郁量表测量的抑郁症状的减轻。次要结果包括自我评估的抑郁症(贝克抑郁量表),在PSI期间对伴侣面部的注意力(眼动追踪),与压力相关的生物标志物(皮质醇,α-淀粉酶,白介素(IL)-1?/ IL-6,心率)变异性),催产素受体基因和5-羟色胺转运蛋白基因的甲基化以及诸如关系质量和同理心等心理结构的自我评价。研究结果将发表在国际同行评审的期刊上以及临床心理学和精神病学领域的会议上。试验注册号为NCT03080025。

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