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临床试验/NCT04990414
NCT04990414已完成2 期

Cognitive Behaviour Therapy for Voices and Dissociation: A Case Series

Greater Manchester Mental Health NHS Foundation Trust0 个研究点目标入组 19 人开始时间: 2013年11月24日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
19
主要终点
Change in the Psychotic Symptoms Rating Scale - auditory hallucinations subscale

研究概览

简要总结

Case series design with participants with psychosis with a history of interpersonal trauma/abuse and current distressing auditory verbal hallucinations and dissociative experience. Participants were offered up to 24 therapy sessions over a 6-month intervention window.

详细描述

Objectives: Previous studies have suggested that dissociation might represent an important mechanism in the maintenance of auditory verbal hallucinations (i.e., voices) in people who have a history of traumatic life experiences. This study investigated whether a cognitive behavioural therapy (CBT) intervention for psychosis augmented with techniques specifically targeting dissociative symptoms could improve both dissociation and auditory hallucination severity in a sample of voice hearers with psychosis and a history of interpersonal trauma (e.g., exposure to sexual, physical, and/or emotional abuse).

Design: Case series.

Methods: A total of 19 service users with psychosis were offered up to 24 therapy sessions over a 6-month intervention window. Participants were assessed four times over a 12-month period using measures of dissociation, psychotic symptoms severity, and additional secondary mental-health and recovery measures.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be in contact with mental health services.
  • Have an identified care coordinator.
  • Meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention in Psychosis service in order to allow for diagnostic uncertainty in early phases of psychosis.
  • History of voice-hearing for a minimum of six months.
  • Aged 16 and above.
  • Score ≥ 2 (i.e. "Voices occurring at least once a day") on the frequency item of the PSYRATS.
  • Score ≥ 3 (i.e. "Voices are very distressing, although subject could feel worse") on the distress intensity rating of the PSYRATS.
  • Confirmed that they consider AVHs, dissociative experiences, and/or trauma as their main problem or presenting difficulty, and that would like to receive a psychological intervention specifically designed to address these difficulties - this will be assessed using four items integrated in the PSYRATS interview administered as part of the present study, and the self-reported therapy goals generated through the CHOICE short form.
  • Score ≥ 1 on any of the items of the Bref Betrayal Trauma Survey assessing lifetime exposure to interpersonal trauma (i.e. items 3-11).
  • scores suggestive of clinical levels of dissociative symptoms, as indicated by a score > 20 on the Dissociative Experiences Scale, time bound
  • Capacity to provide informed consent.
  • Judged by their clinician to be clinically stable for the preceding 4 weeks

排除标准

  • Any person without capacity to provide written informed consent.
  • If the experience of voices/psychosis is organic in origin (for example, hallucinatory experiences linked to traumatic brain injuries, organic psychoses, or emerging in the context of dementing conditions).
  • Insufficient command of English to complete the research interviews and measures.
  • Intellectual disability, or severe cognitive dysfunction that might preclude the individual's ability to provide informed consent, understand the study procedure and/or fully appreciate the potential consequences of their participation.
  • Primary diagnosis of substance misuse dependency.
  • Where care coordinators identify reasons for why participation might be potentially detrimental.
  • Inpatient/acute care needed.

结局指标

主要结局

Change in the Psychotic Symptoms Rating Scale - auditory hallucinations subscale

时间窗: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

change in the severity of hallucinatory experiences, assessed via a clinical interview measuring for presence and severity of auditory hallucinations in the previous week

Change in the Dissociative Experiences Scale - time bound

时间窗: baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment

Change in the frequency of dissociative experiences, assessed via a questionnaire measure assessing presence and frequency of dissociative experiences in the previous month

次要结局

  • Change in the Psychotic Symptoms Rating Scale - delusions subscale(baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment)
  • Change in the Impact of Events Scale Revised(baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment)
  • Change in the short Depression, Anxiety and Stress Scales(baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment)
  • Change in the Questionnaire about the Process of Recovery(baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment)
  • Change in the short-form of the CHoice of Outcome In Cbt for psychosEs (CHOICE)(baseline, at mid-treatment (approximately 3 months after the baseline assessment), at the end of treatment (6 months after baseline), and again at 6 months following the end of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Filippo Varese

Senior Clinical Lecturer

University of Manchester

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