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临床试验/NCT02853396
NCT02853396Unknown不适用

A Pilot of a Brief Cognitive Behaviour Therapy Formulation Focused Intervention for Internalised Stigma With Acute Inpatients That Experience Psychosis

Lisa Wood1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Internalised stigma of mental illness scale

研究概览

简要总结

Stigma is a significant concern for those who experience psychosis. People with psychosis are the most stigmatised group of all mental health difficulties. There is a lack of research examining the effectiveness of psychological therapies for people who experience psychosis who are also experiencing negative impacts of stigma. To date, all studies examining stigma therapies have been conducted with outpatients and no support have been developed for inpatients. The aim of this study to conduct a pilot randomised controlled trial of a brief therapy (based on cognitive behavioural therapy)to help participants cope with stigma. It will be compared to a educational control intervention. Both therapies will last approximately two hours and be conducted in one or two sessions by the principal investigator (clinical psychologist). Participants will be given a number of questionnaires assessing a number of outcomes such as impacts of stigma, depression, recovery, and self-esteem. Participants will be assessed on these measure prior to the therapy, post therapy and at follow-up.

详细描述

A single-blind randomised controlled pilot trial will be conducted comparing a Cognitive Behaviour Therapy formulation driven internalised stigma intervention (experimental group) against a psychoeducational control intervention (control group). It will follow recommendations outlined by the Medical Research Council's framework for the development and evaluation of complex interventions. This will allow for the medication of the intervention if necessary in order to examine what type of intervention is best suited to the inpatient environment.

Aim: To examine the efficacy of a formulation driven intervention for internalised stigma in psychosis with acute inpatients. The intervention will be compared to a brief psychoeducational internalised stigma intervention.

Description of therapies:

Experimental Condition The experimental condition will receive a two hour intervention session (across one or two sessions) which will be based on a Cognitive Behaviour therapy formulation. These sessions will be undertaken within a two week period. The sessions will collaboratively assess and create a narrative of the participants' experiences of stigma, and develop a personalised stigma formulation. A stigma-related goal will be identified and a brief intervention will be collaboratively developed to tackle this goal. The intervention formulation and change mechanisms will draw upon strategies for people who experience psychosis. Intervention strategies may include guided discovery, skills development, normalising and belief change strategies, including behavioural experiments targeting stigma-relevant appraisals and negative beliefs about self including public stereotypes of psychosis, and supporting decisions about whether to disclose.

Control Condition The control condition will receive a two hour session receiving psychoeducation and normalising material relating to stigma in psychosis. The aim of the material is normalise experiences of psychosis and stigma. Information includes prevalence rates of psychosis, experiences of stigma and discrimination commonly reported by those who experience psychosis.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 18-65
  • •Who meet criteria for a schizophrenia-spectrum diagnoses (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified; ICD-10)
  • •Able to give in-formed consent and have capacity to consent
  • •Receiving care from a clinical in-patient team
  • •Able to complete the interview in English
  • •Self-report being concerned about stigma

排除标准

  • •Non-English speakers (due to translation costs)
  • •An acquired brain injury or substance misuse judged to be the acute cause of the psychotic experiences
  • •Lacking capacity for informed consent (the applicant will work with the participant to assess whether they understand the information sheet and study and therefore their ability to give informed consent)
  • •Experiencing severe thought disorder

研究组 & 干预措施

Cognitive behavioural therapy

Experimental

Cognitive behaviour therapy

干预措施: Cognitive Behaviour Therapy (Other)

Psychoeducation

Active Comparator

psychoeducation

干预措施: Psychoeducation (Other)

结局指标

主要结局

Internalised stigma of mental illness scale

时间窗: 10 minutes

次要结局

  • Process of Recovery Questionnaire(5 minutes)
  • Beck Depression Inventory(5 minutes)
  • Beck Hopelessness Scale(5 mins)
  • Self-Esteem Rating scale(5 mins)
  • Attitudes towards mental health scale(5 mins)

研究者

发起方
Lisa Wood
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lisa Wood

Clinical Psychologist

University of Manchester

研究点 (1)

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