OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in PANSS Negative Symptoms
研究概览
简要总结
The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated a lower NS by OXT administration in the positive social context of MBGT in SSD. The investigators also demonstrated that NS and other symptoms improved after mindfulness-based group psychotherapy (MBGT). The aim of this study in individuals with SSD is to examine the effect of combining OXT administration with MBGT on NS, affect, and stress with psychological and biological markers. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
详细描述
Schizophrenia spectrum disorders (SCZ) are severe mental illnesses with a lifetime prevalence of 1-2%. Three core syndromes characterize SCZ: positive and negative syndromes (NS), as well as a cognitive syndrome. The effectiveness of current treatment options for negative symptoms (NS) and sociocognitive deficits in schizophrenia spectrum disorders (SSD) remains limited.
The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated lower NS by OXT administration in a positive social context of MBGT in SSD. The investigators also demonstrated that NS and other symptoms improved after mindfulness-based group psychotherapy (MBGT).
The aim of this study in individuals with SSD is to examine the effect of combining OXT administration with MBGT on NS, affect, and stress. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS, i.e. the difference in T7 - T0 of the negative syndrome subscale of the PANSS (Positive and Negative Syndrome Scale) after 4 weeks. The PANSS as a validated and structured clinical interview will be collected by a blinded psychiatrist. MBGT - sessions by experienced psychotherapists take place over four weeks. These sessions as a positive social context take place once a week in a group of about six patients. Participants received either synthetic oxytocin or a placebo 30 minutes before MBGT.
The role of genetic variations (OXTR genes) for the treatment effect on NS will be explored too as well as the effect on various stress markers including cortisol levels and the endocannabinoid system, affect, group cohesion and mindfulness.
The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •declaration of consent
- •Psychiatric diagnosis of schizophrenia (ICD-10: F2x.x spectrum) for group of patients
- •Mild to moderate positive symptoms (5 ≤ Positive symptoms on individual items using P- PANSS)
- •German should either be the native language or spoken at a native level.
- •No change in systematically recorded psychopharmacological medication in the last 2 weeks before study inclusion.
排除标准
- •Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 6 ≥ positive symptoms on individual items using P-PANSS).
- •Acute suicidality
- •Acute consumption phase of a substance dependence, except nicotine
- •No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage
- •Pregnancy and breastfeeding
- •Current electroconvulsive therapy
- •If one of the following criteria applies to the participants, we will conduct an individual consultation in advance to determine whether participation in the study is possible:
- •Overweight or underweight (body mass index (BMI) < 17.5 or > 30)
- •Disease of the endocrine system
- •Impaired kidney or liver function
- •Metabolic diseases
- •Change in blood potassium or sodium levels
结局指标
主要结局
Change in PANSS Negative Symptoms
时间窗: Baseline (T0), post-intervention at week 4 (T4) and follow-up (week 8, T5)
The Positive and Negative Syndrome Scale (PANSS) is one of the most widely used rater instruments for the assessment of the presence and severity of psychotic symptoms. Each scale comprises seven statements which are rated by the interviewer using a seven-point Likert format (from 1= absent to 7= extreme). The PANSS is reported to have satisfactory internal consistency, good interrater reliability and construct validity.
次要结局
- Change and group differences in cortisol saliva levels(Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T5))
- Change and group differences in GCQ-S Group Climate Questionnaire (Short Version)(Post-intervention at week 1-4 (T1-T7))
- Change and group differences in BNSS Brief Negative Symptom Scale(Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8))
- Change and group differences in SNS Negative Symptoms(Baseline (T0), post-intervention at week 2 (T3), post-intervention at week 4 (T9) and follow-up (week 8, T5))
- Change and group differences in DASS-21 Depression, Anxiety, and Stress Scale(aseline (T0), post-intervention at week 2 (T3), post-intervention at week 4 (T7) and follow-up (week 8, T9))
- Change and group differences in stress via visual analogue scale (Bubbles)(Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T8))
- Change and group differences in CDSS Calgary Depression Scale of Schizophrenia(Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8))
- Change and group differences in PANAS (Positive and Negative Affect Scale)(Baseline (T0), pre- and post-intervention in week 1 - 4 (T1-T7) and follow-up (week 8, T8))
- Change and group differences in PSP Social Functioning(Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8))
- Change and group differences in SMQ Mindfulness(Baseline (T0), post-intervention at week 4 (T7) and follow-up (week 8, T8))
- Change and group differences in endocannibinoid levels(Baseline (T0), post-intervention week 1 (T1), post-intervention week 4 (T7) and follow-up (week 8, T8))
研究者
Kerem Böge
PD Dr. Dr.
Charite University, Berlin, Germany