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临床试验/NCT06591754
NCT06591754Enrolling By Invitation不适用

A Pilotstudy Investigating Feasability, Acceptability and Preliminary Effects of ISTDP (Intensive Short Term Dynamic Psychotherapy) for Patients with Personality Disorder in a Psychiatric Clinic Specialized on Depression, Anxiety and PTSD

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
34
试验地点
2
主要终点
Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews

研究概览

简要总结

The primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using Intensive Short-Term Dynamic Psychotherapy (ISTDP) for patients diagnosed with personality disorders. The secondary objective is to investigate preliminary effects of the treatment in terms of reducing symtoms of depression, anxiety and emotion regulation difficulties.

详细描述

The investigators vill investigate a 25-week treatment with ISTDP that consists of both weekly group- and individual therapy for patients diagnosed with personality disorder in a psychiatric clinic specialized on depression, anxiety and PTSD. The feasibility and acceptability and preliminary effects will be evaluated using a within-group design with repeated measures and qualitative interviews. Patients will be recruited from the clinic and the main inclusion criteria is that the patient have a personality disorder diagnosis.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Personality disorder diagnosis (Clinical assessment using STIP-5) Speaks Swedish fluently

排除标准

  • Autism or intellectual disability Borderline, antisocial or narcissistic personality disorder diagnosis Need for interpreter Urgent social misery Psychotic disorder High suicidality

结局指标

主要结局

Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews

时间窗: Immediately after treatment completion

Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews

Depression symtoms

时间窗: Baseline, weekly throughout treatment, immediately after treatment completion and 6-month follow-up

Depression symtoms will be measured with Patient Health Questionnaire (PHQ-9; (Kroenke et al., 2001)

Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)

时间窗: Immediately after treatment completion (25 weeks)

Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)

Adverse events related to the treatment

时间窗: From start of treatment up to. 6 month follow up.

Adverse events related to the treatment

Number of individual sessions attended during the treatment

时间窗: Throughout the treatment period, up to 25 weeks

Number of individual sessions attended during the treatment

Number of group sessions attended during the treatment

时间窗: Throughout the treatment period, up to 25 weeks

Number of group sessions attended during the treatment

Number of dropouts

时间窗: Throughout the treatment period, up to 25 weeks

Number of dropouts

Total number of sessions attended during the treatment

时间窗: Throughout the treatment period, up to 25 weeks

Total number of sessions attended during the treatment

次要结局

  • Fear of negative emotions(Change from baseline to post-treatment (25 weeks) and follow up 6 months after treatment.)
  • Anxiety symtoms(Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.)
  • Symtoms of Borderline Personality disorder(Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.)
  • Emotions regulation difficulties(Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.)
  • Working alliance(Weekly throughout treatment , up to 25 weeks)
  • Emotional activation during therapy(Weekly throughout treatment, up to 25 weeks)
  • Severity of personality disorder(Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.)
  • Quality of life(Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.)

研究者

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

Maria Bragesjo

PhD and licensed psychologist

Karolinska Institutet

研究点 (2)

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