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临床试验/ISRCTN16166070
ISRCTN16166070已完成未知

Increasing access to CBT for psychosis patients: a feasibility, randomized controlled trial evaluating brief, targeted CBT for distressing voices delivered by Assistant Psychologists

Sussex Partnership NHS Foundation Trust0 个研究点目标入组 79 人开始时间: 2019年2月5日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
79

研究概览

简要总结

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32238176 protocol (added 03/04/2020) 2021 Results article in https://doi.org/10.1192/bjo.2021.983 (added 14/09/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Current inclusion criteria as of 10/01/2020:
  • Participants must:
  • 1. Be aged 16 years or older
  • 2. Be in contact with Secondary Care Mental Health Services (under the care of a Consultant Psychiatrist)
  • 3. Be currently experiencing voice hearing; operationalized by participants having a score of at least 1 on item 1 (How frequently did you hear a voice or voices?) on the Hamilton Program for Schizophrenic Voices Questionnaire (HPSVQ) - indicating that the participant has experienced at least one episode of voice hearing in the past week
  • 4. Be distressed by hearing voices; operationalized by participants scoring at least 8 out of 16 on the ‘negative impact’ scale of the HPSVQ
  • 5. Meet DSM-5 Research criteria for Schizophrenia Spectrum or Other Psychotic Disorders (assessed by the Structured Clinical Interview for DSM-5 disorders, SCID-5)
  • 6. Be willing and able to provide written, informed consent
  • Previous inclusion criteria:
  • Participants must:
  • 1. Be 18 years or older
  • 2. Be in contact with Secondary Care Mental Health Services (under the care of a Consultant Psychiatrist)
  • 3. Be currently experiencing voice hearing; operationalized by participants having a score of at least 1 on item 1 (How frequently did you hear a voice or voices?) on the Hamilton Program for Schizophrenic Voices Questionnaire (HPSVQ) - indicating that the participant has experienced at least one episode of voice hearing in the past week
  • 4. Be distressed by hearing voices; operationalized by participants scoring at least 8 out of 16 on the ‘negative impact’ scale of the HPSVQ
  • 5. Meet DSM-5 Research criteria for Schizophrenia Spectrum or Other Psychotic Disorders (assessed by the Structured Clinical Interview for DSM-5 disorders, SCID-5)
  • 6. Be willing and able to provide written, informed consent

排除标准

  • Current exclusion criteria as of 10/01/2020:
  • Participants must not:
  • 1. Have an established organic cause for distressing voices (e.g. brain disease or injury)
  • 2. Have a primary diagnosis of substance misuse
  • 3. Have completed a full course (minimum of 16 hours) of CBT for psychotic symptoms during the past year
  • 4. Be currently participating, or be confirmed to participate in another interventional study in which they are receiving an intervention which utilizes psychological therapy
  • 5. Be non-English speaking to the degree that the participant is unable to fully understand and answer assessment questions or give informed consent
  • 6. Have severe learning disability (mild to moderate will not be excluded) assessed using the TOPF-UK
  • 7. Be at immediate and serious risk to self or other (assessed at the point of referral/eligibility review)
  • 8. Be detained in hospital under a section of the Mental Health Act
  • Previous exclusion criteria:
  • Participants must not:
  • 1. Have an established organic cause for distressing voices (e.g. brain disease or injury)
  • 2. Have a primary diagnosis of substance misuse
  • 3. Have completed a full course (minimum of 16 hours) of CBT for psychotic symptoms during the past year
  • 4. Be currently participating, or be confirmed to participate in another interventional study in which they are receiving an intervention which utilizes psychological therapy
  • 5. Be non-English speaking to the degree that the participant is unable to fully understand and answer assessment questions or give informed consent
  • 6. Have severe learning disability (mild to moderate will not be excluded) assessed using the TOPF-UK
  • 7. Be at immediate and serious risk to self or other (assessed at the point of referral/eligibility review)

研究者

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