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临床试验/NCT02974400
NCT02974400已完成不适用

Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for Persecutory Ideation and Auditory Verbal Hallucinations

University of Bern4 个研究点 分布在 2 个国家目标入组 101 人开始时间: 2016年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
4
主要终点
Positive and Negative Syndrome Scale (PANSS)

研究概览

简要总结

Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis (CBTp), its dissemination into routine mental health care remains poor. National regulations such as the National Institute for Health and Care Excellence (NICE) guideline in the United Kingdom recommend that CBTp should be offered to every person with psychotic symptoms, but more than 50% do not receive even a single session of CBTp. In Germany, CBTp is virtually not represented in the psychotherapy health service. Internet-based cognitive behavioral therapy (CBT) in a self-help format has been proven feasible and effective in anxiety and depressive disorders. Recently, Internet-based (self-help) interventions are also deployed via smartphone apps. The feasibility of Internet-based treatments for people with schizophrenia is well documented for Internet-based interventions (e.g., medication management) and also reported for smartphone interventions. However, there is a dearth of empirical studies precluding a conclusive picture. As far as the investigators know, there is only one study encompassing 90 participants with psychosis that investigated an Internet-based intervention with symptom-specific, cognitive behavioral interventions, which is from the investigators' research group. The unique features of the proposed project are 1) the first-time evaluation of a symptom-oriented, CBTp-based self-help treatment for people with psychotic symptoms via Internet, enhanced with smartphone assistance. The study is set up as randomized controlled trial (RCT) with active treatment versus a wait-list control group. It evaluates a combined Internet-based guided self-help treatment for persecutory ideation and auditory verbal hallucinations. The active treatment condition consists of access to a self-help website including regular written electronic contact with a guide and access to smartphone-based interactive worksheets (apps). The trials combine the low-threshold advantages of an online approach (e.g., anonymity) with the virtues of a clinical trial (e.g., symptom assessment and diagnostic verification via Interview). The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS). Secondary outcome measures include self-reported symptom measures (Paranoia Checklist; Beliefs About Voices Questionnaire revised), completion rates, drop-out from the intervention, general symptomatology, side-effects, and client satisfaction. The project will help to answer the empirical question whether CBTp-based interventions in a purely Internet-based self-help format are effective. Positive findings would pave the way for an easy-to-access treatment option for patients with psychotic symptoms who currently are deprived of psychotherapeutic treatment.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Electronic informed consent
  • Internet access
  • Adequate command of the German language
  • PANSS Suspiciousness/persecution >= 3 AND/OR PANSS hallucinations >=3
  • Diagnosis of schizophrenia, schizoaffective disorder or delusional disorder
  • Concurrent psychopharmacological treatment

排除标准

  • Acute suicidality
  • Acute risk of endangering others
  • No emergency plan (with is formulated during the telephone interview)
  • Disease of the central nervous system with need for treatment

研究组 & 干预措施

Internet-based guided self-help

Experimental

Internet-based, guided, CBT-oriented self-help treatment for persecutory ideation and auditory verbal hallucinations with access to a self-help website including regular written electronic contact with a guide and access to smartphone-based interactive worksheets (8 weeks)

干预措施: Internet-based, CBT-oriented, guided self-help (Behavioral)

Wait-List

No Intervention

Wait-list control group (8 weeks)

结局指标

主要结局

Positive and Negative Syndrome Scale (PANSS)

时间窗: Change in PANSS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)

Kay et al. (1987); clinician administered

次要结局

  • Quality of life (WHO-QOL)(Change in WHO-QOL from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module))
  • Patient Health Questionnaire (PHQ-9)(Change in PHQ-9 from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module))
  • Paranoia Checklist (PC)(Change in PC from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module))
  • Launay-Slade Hallucination Scale (LSHS)(Change in LSHS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module))
  • Incongruence Scale (INK)(Change in INK from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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