The Relationship Between Mindfulness and Empathy With the Oxytocinergic System in Persons With Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in oxytocin levels
研究概览
简要总结
Recent studies indicated positive effects of mindfulness-based interventions (MBI) for schizophrenia (SCZ), but also on oxytocin (OXT) levels in healthy persons. It was also shown that response to MBI could be shaped by genetic factors. However, the interplay between mindfulness and empathy and genetic factors with the oxytocinergic system has not yet been examined in SCZ. The aim of the current explorative study is to (1) explore the effect of mindfulness-based group therapy (MBGT) on OXT levels as well as empathy in persons with SCZ; (2) investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in persons with SCZ; (3) investigate whether PRS for empathy and specific genetic configurations in the oxytocin receptors are associated with MBGT outcomes and OXT levels; 4) examine changes in positive- and negative symptoms, depression, anxiety, social functioning, and mindfulness at a within-group level and between both conditions.
A parallel-group, proof-of-concept randomized controlled trial with 30 participants allocated to each trial arm (N = 60) will be conducted. Participants will be randomly assigned to MBGT alongside treatment as usual (MBGT+TAU) or treatment as usual (TAU). For a treatment period of four weeks, participants will receive weekly MBGT sessions. Four weeks after baseline assessments (T0), post-intervention assessments (T1) will take place. As a pilot study, effect sizes will be estimated for within- and between-group effects with corresponding confidence intervals.
Outcomes of our proof-of-concept study can provide insight into potential biological mechanisms underlying mindfulness in SCZ, determine a valid biomarker associated with empathy and negative symptoms and pave the way for a personalized treatment approach for individuals with SCZ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The condition will be revealed to the participants after all T0 assessments have been completed
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be aged between 18 and 65
- •meet diagnostic criteria for schizophrenia (ICD-10: F20.X) ascertained by a trained psychiatrist
- •sufficient German language proficiency to engage with the intervention
- •no recent (<4 weeks) major change in psychopharmacologic medication
- •be able to give written informed consent
排除标准
- •a score of 7 on any item of the positive scale of PANSS, suggesting severe psychotic symptoms
- •acute suicidality
- •current substance use other than nicotine
- •neurological disorders or brain damages
结局指标
主要结局
Change in oxytocin levels
时间窗: Baseline and week 4
Venous blood samples will be taken to determine the basal oxytocin plasma to obtain an individual baseline and comparison level. Furthermore, saliva samples will be taken before and after each MBGT session to determine OXT levels.
Change in empathy levels IRI
时间窗: Baseline and week 4
Interpersonal Reactivity Index (IRI) The IRI measures empathy on four subscales: perspective taking, fantasy, empathic concern and personal distress. Each subscale consists of 4 items rated on a 7-point Likert scale. The internal consistent is satisfactory with a Cronbach´s alpha of .78.
Change in empathy levels EQ
时间窗: Baseline and week 4
Empathy Quotient (EQ) The EQ consists of 40 statements to which participants have to indicate the degree to which they agree or disagree. There are four response options: 'strongly agree', 'slightly agree', 'slightly disagree', 'strongly disagree'. 'Definitely agree' responses score two points and 'slightly agree' responses score one point on half the items, and 'definitely disagree' responses score two points and 'slightly disagree' responses score one point on the other half. The remainder of the response options score 0. Finally, Cronbach's alpha was 0.92, which is high.
次要结局
- Change in SMQ Mindfulness(Baseline and week 4)
- PSP Social Functioning(Baseline)
- Change in PANSS Positive, Negative, and General Symptoms(Baseline and week 4)
- Change in DASS Depression & Anxiety(Baseline and week 4)
- Change in CFQ Psychological Flexibility(Baseline and week 4)
- Change in PANAS Positive and Negative Affect(Baseline and week 4)
- Change in SNS Negative Symptoms(Baseline and week 4)
- Change in BIRT Motivation (BMQ)(Baseline and week 4)
研究者
Kerem Böge
Dr. Dr.
Charite University, Berlin, Germany