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临床试验/NCT03935243
NCT03935243Unknown不适用

Efficacy of Equine Assisted Therapy on Psychosocial Functioning, Negative Symptoms and Quality of Life in Patients With Schizophrenia: a Prospective, Randomised and Controlled Study

University of Zurich1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年9月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
16
试验地点
1
主要终点
Changed negative symptoms retrieved from psychometric instruments (BNSS) after the intervention

研究概览

简要总结

The main object of this study is to evaluate the efficacy of equine assisted therapy on substantial and so far unsatisfactorily treatable symptom complexes in patients with schizophrenia.

详细描述

The clinical picture in schizophrenia involves changes in perception, cognition, and affect such as delusions, hallucinations, and disorganized thinking and disorders of attention, memory, and executive thinking. A clinical differentiation, which is widespread in practice, divides the psychopathological disorders of schizophrenic patients in the clinical core areas into positive and negative symptoms.

The term negative symptoms was introduced by Hughlings-Jackson, who made the distinction between florid-psychotic or positive symptoms and "defect" or negative symptoms. The term "positive symptoms" usually includes delusions, hallucinations and formal thinking disorders. The latter are often explained in recent research tradition as a separate "disorganization syndrome". Negative symptoms also appear in the context of other psychiatric and neurological disorders, for example in patients with depression, Parkinson's and craniocerebral traumas.

Negative symptoms, according to Frith and Done, essentially signify a "deficit of willed action" or, more generally, a pathological deficit of activity and reactivity. To establish a border between idiopathic, i.e. primarily due to schizophrenia, outlasting ("trait") negative symptoms and secondary, temporary ("state") negative symptoms Carpenter and colleagues introduced the concept of the deficit vs. non-deficit form of schizophrenia. Negative symptoms constituting the deficit syndrome include affective flattening, limited emotional range, loss of interest, speech depletion, diminished purposefulness, and social listlessness. These symptoms are considered to be primary negative symptoms if they persist beyond the onset of an acute psychotic episode and have been established by differential diagnosis that they are not or at least not entirely secondary to the presence of depression, the side effects of antipsychotic treatment or other circumstances. While primary negative symptoms are currently largely immune to any type of treatment, secondary negative symptoms may remit spontaneously or after appropriate treatment.

Men are more frequently and stronger affected by negative symptoms than women. Also, the negative symptoms manifest themselves earlier in the course of the disease and are associated with stronger cognitive impairments than in women. However, the extent of men's deficits varies little during further psychotic episodes, while women tend to have a progressive profile. Recruitment for the current study will take into account the prevalence.

The positive symptoms can be treated very effectively with medication and stabilization can usually be achieved within a few weeks. On the other hand, the negative symptoms are very difficult to influence with medication. Ideally, modern integrative psychiatric treatment concepts therefore incorporate a combination of pharmacological, psychotherapeutic and psychosocial treatment strategies adapted to the specific symptom constellation and the particular needs and deficiencies of the individual patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia (ICD-10: F20.0-20.3, F20.5)
  • men or female patients (older than 18 years of age)
  • written informed consent

排除标准

  • acute risk of harming oneself or others
  • severe manifest allergies
  • medically uncontrolled epilepsy
  • Significant side effects of medication (blood pressure fluctuations with dizziness, movement-limiting Parkinson's disease, etc.).

结局指标

主要结局

Changed negative symptoms retrieved from psychometric instruments (BNSS) after the intervention

时间窗: week 0 (t1), week 8 +/- 1 day (t2), week 15 +/- 2 days (t3)

BNSS: 5 domains for the negative symptoms are recorded, namely "blunted affect", "alogie", "asociality", "anhedonia" and "avolition". The BNSS also distinguishes between the anticipatory and the consumptive aspects of anhedonia, which are distinct advantages over other questionnaires such as PANSS or SANS (Kirkpatrick 2011, Marder \& Kirkpatrick 2014). With its 13 items that can be collected within 15 minutes, the BNSS is a short scale that, despite its shortness, has excellent inter-rater and test-retest reliability and good validity. Furthermore, there are only small correlations of the BNSS with masses of positive symptoms, anxiety and depression (Strauss et al., 2012, Kirkpatrick et al., 2011). Like the PSP scale, the BNSS is surveyed during the first, second and third rounds and here too the surveys are conducted by experienced psychologists or psychiatrists.

Changed psychosocial functioning after the intervention (PSP)

时间窗: week 0 (t1), week 8 +/- 1 day (t2), week 15 +/- 2 days (t3)

PSP: External rating scale consisting of 4 subscales, which are calculated to a total score ranging from 0 to 100. The 4 scales are "disturbing and aggressive behavior," "self-care," "socially beneficial activities," and "personal and social relationships" (Morosini et al., 2000). The individual items are queried on a 6-point scale, which includes the expressions "absent", "easy", "obvious", "pronounced", "severe" and "extremely serious". Explanations are available for the respective characteristics. Schaub and Juckel (2011) have also created an interview guide for the German version, which should further simplify the assessment. The individual surveys are carried out by experienced psychologists or psychiatrists. The PSP scale was chosen because it is quick and easy to query, has a higher information content than other scales (e.g., SOFAS or GAF), and also has high validity and reliability.

次要结局

  • Changed quality of life (Quality of Life Questionnaire in Schizophrenia (S-QoL)(week 0 (t1), week 8 +/- 1 day (t2), week 15 +/- 2 days (t3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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