跳至主要内容
临床试验/NCT03853382
NCT03853382已完成不适用

Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH): A Feasibility Trial

University of Manchester2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Feasibility - completion rate of assessments

研究概览

简要总结

Non-suicidal self-injury (NSSI) is when somebody engages in self-harm, such as cutting, without meaning to end his or her life. A large number of people engage in NSSI for lots of reasons, for example to cope with emotions. However, currently there are large waiting lists to access psychological therapy through the NHS. Therefore, it is important to research brief therapies so that individuals who engage in NSSI can receive treatment quicker. One potentially helpful therapy suggested is Cognitive Analytic Therapy (CAT), which focuses on patterns in relationships. NSSI can be understood as a way in which people relate to themselves, which suggests that CAT would fit well in terms of understanding and working with these difficulties.

This study aims to evaluate a brief two-session CAT therapy for people who engage in NSSI. The project aims to evaluate the feasibility and acceptability of the therapy, using interviews and questionnaires. This means looking at whether participants stick with the therapy, and how they find taking part in the therapy.

All participants will meet with a researcher for an initial session to complete baseline questionnaires about their current difficulties, thoughts and feelings. Participants will then be randomly allocated to a condition: either the therapy condition or the treatment-as-usual (TAU) condition. Participants in the therapy condition will receive two therapy sessions, whilst participants in the TAU condition will not receive any therapy sessions. All participants will attend a final session to complete more questionnaires. Participants will be asked to complete online surveys weekly. Some participants will be invited to take part in interviews about their experience of the therapy. All participants will receive a shopping voucher as compensation for their time. Using the data collected from this study, future work can be done to provide better treatment for people who engage in NSSI.

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
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

  • Be aged over 16 years (parental consent is not needed; The British Psychological Society, 2008)
  • Be comfortable with and have access to email and the internet for completing study measures
  • Be currently under or receiving support form clinical/health service including NHS, 3rd sector, or University health services
  • Following DSM-V (American Psychiatric Association, 2013), have had five or more instances of NSSI in the past year:
  • NSSI methods are operationalised to include cutting, burning, biting, or scratching oneself, as well as head-banging or self-poisoning.
  • Have an adequate English language ability to understand study materials
  • Be deemed capable of providing informed consent by their clinical team.

排除标准

  • Be currently receiving any other psychological therapy (e.g. including but not limited to CBT and/or DBT), and will not have received psychological therapies in the last one month.
  • Have previously received any CAT
  • Have been diagnosed with Learning Disability or Autistic Spectrum Disorder as judged by clinical team - since the intervention has not been developed for this population
  • Be currently judged at high risk of suicidal behaviour (although if participants were keen to be involved, they could be considered when their mental health has improved).
  • Have been hospitalised as a result of self-harm in the past month

结局指标

主要结局

Feasibility - completion rate of assessments

时间窗: Five weeks

Feasibility will be based upon (i) \> 70% of participants attending the post-therapy follow-up point and (ii) a rate of missing data per outcome measure of \< 25% (this rate of missing data has been used to indicate high risk of bias within systematic reviews; Hutton et al., 2015).

Safety- adverse experiences

时间窗: Five weeks

Safety will be assessed via an Adverse Effects in Psychotherapy (AEP) self-report measure (Hutton, Byrne \& Morrison, 2017; unpublished). Items rated as greater than "a little" will be classified as notable adverse experiences. Adverse events occurring during the course of the trial (identified through discussion with the participant or clinical team) will also be monitored and recorded. These will include hospitalisation (related to mental health), medically serious self-harm (i.e. requiring medical intervention), and suicidal ideation where a plan and intent are present.

Acceptability- attendance rates

时间窗: Five weeks

We will judge the intervention feasible based on whether \> 70% of those randomised to receive the intervention complete both sessions.

次要结局

  • Depressive symptoms(Five weeks)
  • Self-concept instability(Five weeks)
  • Self-injury urges(Five weeks)
  • Non-Suicidal Self-Injury(Five weeks)
  • Self-Compassion Scale (SCS; Neff, 2003).(Five weeks)

研究者

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

Peter Taylor

clinical lecturer

University of Manchester

研究点 (2)

Loading locations...

相似试验

Cognitive Analytic Therapy-informed Containment for... | 临床试验