Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Attunement and Responsiveness towards patients
研究概览
简要总结
In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain.
详细描述
In the past few decades, efforts have been made to explore the potential augmenting effect of neurobiological compounds for patients with mental disorders (Hertenstein et al, 2021). One of these compounds is Oxytocin (OT), a nine-amino acid neuropeptide generated in the hypothalamus and released by the pituitary gland (Brownstein et al., 1980). Oxytocin has been suggested to be one of these possible facilitators when administered in clinical settings (Peled-Avron et al., 2020). Studies show that OT administration can enhance social abilities of children with autism spectrum disorder (Yatawara et al.,, 2016; Parker et al., 2017), decrease depression and anxiety symptoms when administered as add-on to antidepressants (Scantamburlo et al., 2015), reduce anxiety and negative self-appraisal following exposure therapy (Guastella et al., 2009; Alvares et al., 2012) and improve theory of mind among patients with schizophrenia (De Coster et al., 2019; Pedersen et al., 2011; Modabbernia et al., 2013).
Aside from its potential direct neural effects, OT was previously suggested to enhance treatment outcomes through its effects on vital interpersonal processes taking place during psychotherapy. As early as 2010, OT was suggested to affect the therapeutic process through its ability to modulate trust and sense of safety, which seem crucial for effective therapeutic processes to take place (Olff et al., 2010). Indeed, studies have documented that OT administration can improve trust and cooperation in humans (Barraza & Zak, 2009; De Dreu, 2012; Xu et al, 2019). Nonetheless, in a recent study conducted by Grossman-Giron et al. (2021), OT administration led to more favorable therapeutic outcomes, but led to no improvement in the therapeutic working alliance between patients and therapists.
One biobehavioral model which can explain the compelling evidence found in Grossman-Giron et al. (2021) is the putative role of OT in the activation of the caregiving system of the therapist. Studies demonstrate that activation of the caregiving system in response to the other's distress is mediated by release of OT (Swain et al., 2012). Studies assessing the neurobiological mechanisms associating OT with caregiving behavior demonstrate that a crying infant increases activation in insula and inferior frontal gyrus in the mothers' brain, and reduces activation in right amygdala, all regions known to be involved in empathy and empathic caregiving responses (Naber et al., 2010; Riem et al., 2011; Swain et al., 2012). Similarly, elevated OT levels in the mother were found to be associated with mothers' response to their infants' stress, a trend which was evident also among foster mothers (Bick & Dozier, 2013). OT administration to fathers was also found increased parental behaviors in father-child dyads (Weisman et al., 2012). These combined findings suggest that OT's effect of vital elements of the therapeutic dyad, such as responsiveness to patients' distress and the ability to convey support, empathy, and trust, might be situated in the therapist.
Although no study has previously tested the effect of OT administration to therapist on therapeutic process and outcome, several correlative studies have provided partial support for such an effect. In a recent study conducted by Fisher et al. (2023), the authors examined therapists' hormonal response as a possible biomarker of effective therapeutic interventions. In this study, therapists' (n=6) OT levels were measured during the ongoing therapy of men (n=62) suffering from depression. The authors found that therapists' OT levels mediated the association between patients' negative emotions and depression severity. Put differently, the authors found that patients' negative emotions were associated with increased levels of OT, which in turn was associated with therapeutic outcomes. These findings might suggest that the elevation in OT system might have produced a shift in specific caregiving mechanisms which produced a more favorable outcome.
Several potential therapist-specific mechanisms might be associated with this elevation of OT occurring during psychotherapy. OT is strongly linked to empathy, which is considered a vital element of the therapeutic process (Elliott et al., 2011). Client-perceived empathy was found to be a predictor of outcome of psychotherapy (Barrett-Lennard, 1981; Elliott et al., 2011). Another potential factor likely to be associated with OT and the caregiving system is therapists' behavioral responsiveness, defined as the therapist's ability to adjust their responses to the current state of the client (Falkenstrom, 2015). In a study conducted by Wu and Levitt (2020), therapist behavioral responsiveness was assessed in a metanalysis of 75 studies. The authors found that specific responses are important in different therapeutic contexts, within psychotherapy interventions and with patients with different characteristics. Finally, it can also be speculated that activation of the caregiving system would lead to changes in attunement, defined as a process of communion and unity of interpersonal contact, going beyond empathy, to create a two-person experience of connectedness by providing a reciprocal affect and/or resonating response (Erskine, 1998). Studies demonstrate that the higher the attunement, the better the outcome (Aafjes-van Doorn et al. 2022). Taken together, these three therapist-specific factors, and how they are specifically perceived by the patient, might be stronger mediators between OT and therapy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oxytocin
24IU (12IU*2) of Oxytocin, Sorbitol, Benzyl, alcohol glycerol, distilled water.
干预措施: Oxytocin nasal spray (Drug)
Placebo
24IU (12IU*2) of Sorbitol, Benzyl, alcohol glycerol, distilled water.
干预措施: Oxytocin nasal spray (Drug)
结局指标
主要结局
Attunement and Responsiveness towards patients
时间窗: 3 weeks
PEAR; Snyder \& Silberschatz, 2017 - The Patient's Experience of Attunement and Responsiveness Scale
次要结局
- Attachment with Therapist(3 weeks)
- Working Alliance with Therapist(3 weeks)
- Patient Symptoms(3 weeks)
