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临床试验/NCT05023447
NCT05023447进行中(未招募)不适用

The BRIDGE Project: A Feasibility Randomised Controlled Trial of Brief, Intensive Assessment and Integrated Formulation for Young People (Age 14-24) Early in the Course of Borderline Personality Disorder

NHS Greater Glasgow and Clyde2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Recruitment & Retention rates

研究概览

简要总结

The BRIDGE project: A feasibility randomised controlled trial of brief, intensive assessment and integrated formulation for young people (age 14-24) early in the course of borderline personality disorder.

详细描述

This project is the first step in testing a new intervention programme, called BRIDGE (Brief, Intensive Assessment and Integrated Formulation), for young people early in the course of Borderline Personality Disorder (BPD). The BRIDGE Project will help us find out whether we can do a much bigger study in the future that will tell us whether BRIDGE works well. BPD is characterised by long standing difficulty in managing emotional responses, personal relationships, impulse control and self-image. Research shows that individuals with BPD may experience discrimination and resulting stigmatisation by both the public and health care professionals. Many adolescents and young people with complex needs and high suicide risk are left under-diagnosed and untreated. As a result, young people with BPD are frequently not in education or training and experience challenging relationships with friends and families. The overall aim of the study is to assess the possibility of providing a treatment programme for young people with BPD symptoms in the general population, who may or may not be accessing any mental health services. First, we need to see whether young people are comfortable with random allocation to BRIDGE (AND service as usual) or Service-as-usual (ALONE) (a bit like tossing a coin). Second, we need to find out whether enough young people want to be involved. Third, whether we can find out the information we need about them and can follow up enough young people later. The proposed study will try to find these things out, so that we can design a future, bigger, study to find out whether BRIDGE is good value for young people with BPD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Randomized

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cut off score of 11 out of 15 on the self-reported SCID-II BPD questionnaire AND subthreshold (3 or 4 out of 9 domains) or threshold (5 and above out of 9 domains) criteria on the SCID-II DSM-V (BPD Module)
  • Age 14-25

排除标准

  • Currently receiving psychological/counselling /psychotherapeutic treatment for BPD
  • Has received psychological/counselling/psychotherapeutic intervention for over 8 sessions in the last 3 months
  • Severe or profound intellectual disability, that would preclude full engagement in talking therapy
  • Receiving Intensive psychiatric treatment at the time of study entry, for conditions such as acute psychosis or severe eating disorder
  • Non-English speaking

结局指标

主要结局

Recruitment & Retention rates

时间窗: Continuous over 3 year study period

The number of participants recruited for randomisation and the number retained to follow-up (12 \& 24wks post randomisation).

次要结局

  • Acceptability of trial processes and interventions(Continuous over 3 year study period)
  • Process Evaluation(Continuous over 3 year study period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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