ISRCTN17346075暂停未知
A randomised controlled trial evaluating the efficacy of Dialectical Behavioural Therapy Skills for Employment (DBT-SE) compared with a referral to a mental health employment specialist for people with difficulties consistent with a personality disorder (PD)
orth East London NHS Foundation Trust0 个研究点目标入组 432 人开始时间: 2019年11月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 发起方
- 入组人数
- 432
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Difficulties consistent with a PD: A score of 3 or more on the Standardised Assessment of Personality - Abbreviated Scale (SAPAS)
- •2. Registered with a UK GP: Willing and able to provide details of the GP practice they are registered with for safety reasons
- •3. Working age: Minimum 18 years old
- •4. Not currently working or working limited hours for limited salary:; (i) Unemployed, (ii) Certified medically unfit to work by GP for a minimum of 4 weeks (by randomisation date) with no planned return to work within the next 3 weeks or (iii) Fulfils the Government requirements for permitted work or supported permitted work, current guidance : working fewer than 16 hours per week, AND, earn less than £131.50 per week (N.B. this will be updated during the study in line with changes to UK government guidelines)
- •5. Eligible for employment in the UK: UK National or UK Resident with Residential/visa status approved for employment and a plan to remain in the UK for a minimum of 18 months
- •6. Available for employment: No commitments that preclude employment (e.g. sole carer for family member/infant who cannot be cared for by another person, full-time student)
- •7. Able to verbally communicate in English and basic reading and writing skills: The intervention is delivered in English so participants will need to be comfortable conversing with other group members. As the intervention uses handouts and homework sheets they will need to have basic reading and writing skills
排除标准
- •1. Florid Psychotic Disorder/symptoms of Psychosis: Measured through seven screening questions adapted from the SCID I. The presence of symptoms implies the volunteer is not suited to the programme and may not have the capacity to consent
- •2. Has received full or modified/adapted DBT during the last 12 months: It would not be appropriate to offer more DBT so soon after treatment ends
- •3. Suicide attempt within the last 12 weeks: Each participant will be questioned regarding suicidal behaviour, where there have been recent (< 12 weeks) incidents of suicidal behaviour the participant will not be permitted to volunteer for the study. This is because the needs of the participant are greater than the study is equipped to support
- •4. Incident of deliberate self-harm within the last 4 weeks: Each participant will be questioned regarding self-harming behaviour, where there have been recent (< 4 weeks) incidents of self-harm the participant will not be permitted to volunteer for the study. This is because the needs of the participant are greater than the study is equipped to support
- •5. Bipolar Disorder diagnosis/ currently in treatment for Bipolar Disorder (Includes being diagnosed with Bipolar Disorder but not currently receiving treatment): A diagnosis of Bipolar Disorder or pharmacological or Psychological treatment for bipolar disorder implies the participant has needs outside of the remit of the study
- •6. PD symptoms due to a head injury: Difficulties are not due to a mental health problem but an organic injury
- •7. Unable to travel to DBT-SE site or MHES site: Participants need to be willing and able to travel to either site
- •8. Receiving a psychological therapy as part of a research study unrelated to EMPOWER: Participants receiving a novel treatment as part of research will be excluded as it will not be possible to accurately quantify and characterise the treatment. If the research intervention will be over before the participant attends baseline data collection and randomisation they will be permitted to join the study but will not if the two could overlap
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