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临床试验/NCT06377709
NCT06377709已完成不适用

A Mixed-methods Acceptability Study of ProACTive, an Early Acceptance and Commitment Therapy Intervention to Help Burns Patients Adjust to Changes to Appearance

Nottingham University Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年6月13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
13
试验地点
2
主要终点
Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A)

研究概览

简要总结

This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy (ACT) based intervention called ProACTive, aimed at supporting burns patients' adjustment to a changed appearance and preventing distress, is acceptable. This will be measured by descriptive data, questionnaire data and semi-structured interviews.

Preliminary data on the potential clinical effectiveness of the intervention will also be gathered. This will be measured by scores on standardised questionnaires.

详细描述

Evidence suggests that appearance concerns after burn injuries start early. Appearance concerns can be chronic, create psychological distress and impact quality of life. No early psychological interventions for appearance concerns after burn injuries currently exist.

ProACTive, a novel psychological intervention (talking therapy), utilising acceptance and commitment therapy (ACT) techniques with an additional focus on developing self-compassion and social skills training, was developed. It aims to help burns patients adjust to changes to appearance and prevent distress. It involves up to five 30-minute modules and patients can select how many, and which, modules to complete. It is delivered by a psychological professional working in burns services.

The primary aim of this study is to explore whether the ProACTive intervention is acceptable to burns patients. A secondary objective is to gather preliminary data on the potential clinical effectiveness of the ProACTive intervention.

A mixed-methods single-arm acceptability study will be conducted.

ProACTive will be offered to burns patients (aged 18 years or over) meeting inclusion criteria and admitted to the burns service at Nottingham University Hospitals NHS Trust.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Adult patients (18 years and over) admitted as inpatients to the burns service with an acute burn injury

排除标准

  • Patients already receiving psychological input from the burns clinical psychology service for appearance related concerns, over and above supportive listening
  • Patients admitted as inpatients to the burns service for reconstructive surgery, for a historical burn injury
  • Patients who are too physically unwell to participate
  • Patients deemed too psychologically unwell or in a mental health crisis by the usual clinical care team (for example, patients who sustained their burn injury due to a suicide attempt or self-harm, are currently having suicidal thoughts, or those with psychosis)
  • Patients who are not fluent in the English language in order to participate
  • Patients with a known cognitive impairment

结局指标

主要结局

Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A)

时间窗: As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending

A 10-item self-report questionnaire that measures appearance concerns/body esteem. Responses to each item fall on a scale between 0 and 4. The total mean score is used, falling between 0 and 4. Higher scores indicate higher appearance esteem (i.e. lower appearance concerns).

次要结局

  • Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)
  • Positive and Negative Affect Schedule (PANAS-GEN)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)
  • Self-Compassion Scale - Short Form (SCS-SF)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)
  • Helpful Aspects of Therapy Form (HAT)(As soon as is feasible before and after the intervention. The post-intervention measure will be completed within one week of the intervention ending)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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