Aguilar-Raab Corina, Jarczok Marc N, Warth Marco, Stoffel Martin, Winter Friederike, Tieck Maria, Berg Judith, Negi Lobsang Tenzin, Harrison Tim, Pace Thaddeus W W, Ditzen Beate
Institute of Medical Psychology, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany.
Department of Psychosomatic Medicine and Psychotherapy, University Clinic Ulm, Ulm, Germany.
BMJ Open. 2018 Oct 4;8(9):e020448. doi: 10.1136/bmjopen-2017-020448.
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.
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)-1ß/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.
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.
NCT03080025.
积极的社会互动（PSI）和稳定的人际关系对健康有益。然而，抑郁症患者从这些促进健康的影响中获益较少。此外，已发现关系质量甚至伴侣的健康会受到抑郁症状的负面影响，这可能导致浪漫伴侣的社会功能出现全面受损。心理生物学研究表明，这些损害可能伴随着患者对外部压力源的神经内分泌反应的适应不良调节。关于社会功能的改善，初步研究显示了“基于认知的慈悲训练（CBCT®）”的良好效果。然而，随机试验仍然很少。以前的项目没有让患者的浪漫伴侣参与。因此，本研究旨在调查一种适用于夫妻的CBCT®项目（CBCT®-fC）是否可以改善抑郁症状、痛苦、社会互动技能以及压力的神经生物学调节。
女性伴侣患有抑郁症的夫妻将被邀请连续两天分别参加干预前后评估，包括标准化的PSI任务、眼动追踪、心电图记录、唾液采样、血液采样和问卷调查数据。在基线评估后，参与的夫妻将被随机分配到为期10周的CBCT®-fC组或常规治疗对照组。主要终点是通过汉密尔顿抑郁量表测量的抑郁症状减轻。次要结果包括自评抑郁（贝克抑郁量表）、在PSI期间对伴侣面部的关注（眼动追踪）、与压力相关的生物标志物（皮质醇、α-淀粉酶、白细胞介素（IL）-1β/IL-6、心率变异性）、催产素受体基因和血清素转运体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评。
已获得海德堡医学院伦理委员会的伦理批准。研究结果将在国际同行评审期刊以及临床心理学和精神病学领域的会议上发表。
NCT03080025。
