跳至主要内容
临床试验/NCT06597864
NCT06597864招募中不适用

Seven-step Phenomenological Psychotherapy for Self-disorder - a Pilot Study

Oslo University Hospital3 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
8
试验地点
3
主要终点
Experience of the seven-step phenomenological psychotherapy model for self-disorders

研究概览

简要总结

The goal of this clinical pilot study is to learn how adults with schizophrenia or other non-affective psychotic disorders or psychosis risk syndromes experience a novel psychotherapeutic treatment for self-disorders. The study has a qualitative, phenomenological research design. After end of treatment, the participants are interviewed about the experience of the treatment. This include how the participants liked it, if it was experienced as helpful and useful, and changes in self-experience and experience of relations to others and the world.

详细描述

Self-disorders are considered as central features of schizophrenia spectrum disorders which may be present both before, during, and after psychotic episodes. They are characterized by disturbances in the sense of ownership to experiences and agency of action, as well as in the sense of presence, reality and existence. They are further considered to drive symptom development during prodromal schizphrenia. Self-disorders may be very painful, and associated with anxiety, disturbances in daily functioning and increased sucidality. There is a lack of studies investigating the effect of psychotherapy on self-disorders. Hence, there is a need for developing and testing new treatment approaches to these debilitating conditions.

In this pilot study the investigators want to test a new model and manual for the treatment of self-disorders, the Seven-Step Phenomenological Psychotherapy for Self-Disorder (SSPP-SD), first developed by Dr.Med Paul Møller. This model focuses on the phenomenological exploration of self-disorders, subjective understanding, meaning and associated behaviors, psychoeducation, and the joint exploration of new meanings and understanding related to the experiences. The length of the treatment is stipulated to 14 individual sessions over 7-10 weeks. The first step of the treatment involves a semi-structured interview with the Examination of Anomalous Self-Experience (EASE).

The study has a qualitative phenomenological design where the primary research question is how the participants experienced the treatment. In more detail, the investigators want to explore both positive and negative experiences, how useful or helpful the participants experienced the treatment, and how the treatment affected self-experience and experience of relations to others and the world. These experiences will be explored in a qualitative interview following the end of treatment. In addition, the participants will answer questionnaires regarding symptoms, functioning, life quality (before and after treatment) and satisfaction with the treatment (after treatment). The study will inform the planning of a larger clinical trial testing the effect of the SSPP-SD on self-disorders in participants with psychotic disorders at Vestre Viken Hospital, Norway. Hence, in this pilot study the investigators will also register and evaluate therapist experiences of the SSPP-SD, and fidelity to the manual. The therapists will be supervised by Dr.med Paul Møller.

Six participants with schizophrenia or other ICD-10 F20-29 disorders, or with psychosis risk syndromes as defined in the Structured Interview for Psychosis-risk Syndromes (SIPS) will be included. They will be included from an outpatient clinic for psychotic disorders at Akershus University Hospital, Norway. Two experienced therapists trained in the model will offer the therapy, including project leader Dr. Tor Gunnar Værnes at the Oslo University Hospital.

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 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnoses in the ICD-10-CM Code range, i.e. schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders. First diagnosed no more than 3 years ago.
  • Or Psychosis risk syndrome as defined in the Structured Interview of Psychosis-Risk Syndromes (SIPS) (McGlashan, Walsh, & Woods, 2010)
  • Present with anomalous self-experiences, as confirmed by the Screen Questionnaire for EASE (SQuEASE-6) (Møller, 2018)
  • Motivated to explore and work with anomalous self-experiences in psychotherapy

排除标准

  • Severe, ongoing psychosis
  • Severe, ongoing drug abuse
  • IQ<70
  • Poor Norwegian language profiency

结局指标

主要结局

Experience of the seven-step phenomenological psychotherapy model for self-disorders

时间窗: After completing the SSPP-SD treatment, up to 12 weeks after study inclusion

Qualitative, semi-structured interview exploring how the participants experienced the therapy.

次要结局

  • General Anxiety Disorder-7 (GAD-7)(Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment)
  • Patient Health Questionnaire-9 (PHQ-9)(Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment)
  • Work and Social Adjustment Scale (WSAS)(Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment)
  • Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)(Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment)
  • Positive and Negative Syndrome Scale-6 (PANSS-6)(Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment)
  • 10-point self-disorder questionnaire(Before the SSPP-SD intervention and at the end of the intervention, up to 12 weeks after enrollment)
  • Examination of Anomalous Self-Experience (EASE)(During the first of sevens steps of treatment, session 1 and 2. Up to 3 weeks after study enrollment)
  • Client Satisfaction Questionnaire (CSQ-8)(After end of SSPP-SD treatment, up to 12 weeks after enrollment)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tor Gunnar Værnes

Principal Investigator

Oslo University Hospital

研究点 (3)

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