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临床试验/ACTRN12617000405314
ACTRN12617000405314已完成未知

‘SIFT’ that social information! Feasibility of a novel social cognition treatment for people with acquired brain injury

niversity of New South Wales0 个研究点目标入组 28 人开始时间: 2017年3月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
28

研究概览

简要总结

This study aimed to determine the feasibility of a novel social cognition group treatment program (SIFT IT! The Social Thinking Therapy) for people with acquired brain injury. Feasibility and initial efficacy outcomes were assessed at three time-points in an RCT design. In total, 28 participants with acquired brain injury were recruited (out of 46 contacted, a recruitment rate of 60%), of which 23 were eligible for the treatment program (82% eligibility rate). These participants were randomised into either the 'treatment' group (N = 12) or the 'waitlist' group (N = 11, who were offered the treatment group following the second assessment time-point). Ten participants started and completed the 'treatment' group, in which mean attendance rates were 92%. At Time 2, there was a 9% attrition rate and over half of the 'waitlist' participants who were offered to take part in the group program agreed to take part (N = 6). Mean attendance rates in the 'waitlist' group program were 89%. By Time 3, there was further attrition, totalling 17% from baseline (Time 1) to follow-up (Time 3). Of 16 participants who commenced the SIFT IT group program, 94% completed the program (N = 1 withdrew after Session 7 due to return-to-work). Further feasibility and initial efficacy outcomes are now being analysed. Results are expected to be disseminated to participants and published in peer-reviewed journals.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • (1) experienced a moderate to severe acquired brain injury (for traumatic brain injury: score on the Glasgow Coma Scale of 9-12 [moderate], 8 or less [severe] and/or a period of post traumatic amnesia of 1-24 hours [moderate], more than 24 hours [severe])
  • (2) at least six months post-injury
  • (3) residing in the community for at least six months
  • (4) between 18 and 65 years of age
  • (5) sufficient cognitive capabilities to participate in assessment and group tasks
  • (6) sufficient English language proficiency to participate in assessment and group tasks
  • (7) performance at least one standard deviation below normative sample on social cognition measures at baseline assessment

排除标准

  • (1) diagnosed developmental delay
  • (2) substantive expressive and/or receptive language impairment
  • (3) recent history or current risk of major psychiatric crisis (e.g. suicide attempt, psychotic relapse)
  • (4) uncorrected visual or hearing impairment

研究者

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