跳至主要内容
临床试验/NCT03434405
NCT03434405已完成不适用

Mindfulness-based Social Cognition Group Training for Persons With Diagnoses of Psychotic Disorders (SocialMind): A Feasibility, Non-randomized Controlled Trial

Instituto de Investigación Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Recruitment rate

研究概览

简要总结

The current investigation has been designed to test the feasibility of a mindfulness-based social cognition training (SocialMind) for people with a first episode of psychosis (AGES-Mind Study, NCT03309475). The intervention has been designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. Main outcomes are recruitment rate, adverse events and treatment adherence, although therapy effects and adjustment to intervention manual are also explored.

详细描述

Social functioning is impaired among many patients with a first episode of psychosis, who also show a lower ability to recognize, understand and benefit from social stimuli (i.e., deficits in social cognition) than their pairs. Both deficits underlie the general functional impairment found across non-affective psychotic syndromes. Since currently available pharmacological strategies have not proven themselves effective in addressing this matter, new psychotherapeutic approaches should be developed. This research team developed a mindfulness-based social cognition group training (SocialMind) designed for persons who have suffered a first episode of psychosis within five years prior to their enrollment in the study (AGES-Mind Study, NCT03309475). Although there is enough evidence to support the lack of adverse events derived for mindfulness-based interventions specifically designed for psychotic patients (Cramer et al., 2016), many clinicians express their concerns about the beneficial effects of these approaches. Therefore, and in keeping with international health organisms such as United Kingdom's National Health Service (NHS), this team have proposed a feasibility study. The main hypothesis is that the AGES-Mind study can be carried out in terms of achievement of recruitment rate, lack of adverse events and levels of treatment adherence. Secondary hypothesis states that clinicians will adhere to SocialMind manual. Finally, a positive effect of the intervention is expected, both in participants' satisfaction and in some relevant variables, such as functional outcomes, clinical global impression and social cognition.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years old
  • Diagnosis of psychotic disorder according to DSM-5 and history of more than five years of psychotic symptoms
  • CGI-SCH equal or lower than four points ("moderately ill")
  • Informed consent given

排除标准

  • Intellectual disability plus impaired global functioning prior to disorder onset
  • Generalized development disorder
  • Substance related disorders (except for nicotine) according to DSM-5

研究组 & 干预措施

SocialMind

Experimental

The experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 5 monthly sessions.

干预措施: SocialMind (Behavioral)

SocialMind

Experimental

The experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 5 monthly sessions.

干预措施: Psychosocial treatment (Behavioral)

SocialMind

Experimental

The experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 5 monthly sessions.

干预措施: Psychotropic treatment (Drug)

结局指标

主要结局

Recruitment rate

时间窗: 0 weeks

At least 25 participants meeting inclusion criteria

次要结局

  • Attrition rate(8 weeks)
  • Change in Psychiatric Symptoms(8 weeks)
  • Change in social functioning(8 weeks)
  • Change in dissociative Symptoms(8 weeks)
  • State anxiety(8 weeks)
  • Change in social attribution(8 weeks)
  • Change in reflective functioning(8 weeks)
  • Change in mindful attention and awareness(8 weeks)
  • Change in neurocognitive status(8 weeks)
  • Participants' satisfaction(8 weeks)
  • Change in clinical global impression(8 weeks)
  • Change quality of life(8 weeks)
  • Change in theory of mind(8 weeks)
  • Change in emotion recognition(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验