跳至主要内容
临床试验/NCT06316258
NCT06316258尚未招募不适用

Evaluating the Feasibility and Acceptability of Compassion Focused Therapy Group Intervention for Adults With Moderate-severe Acquired Brain Injury in an Inpatient Neurorehabilitation Setting

King's College London0 个研究点目标入组 12 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
12
主要终点
Practicality - delivery of intervention

研究概览

简要总结

Emotional difficulties such as anxiety and depression are common after experiencing a brain injury. The compassion focused therapy (or CFT) model proposes the importance of developing skills in being able to self-soothe and be self-compassionate to counteract feelings of distress. Several studies have shown that therapy groups using CFT techniques are helpful, but there has only been one previous study of a CFT group with people with acquired brain injury. This study aims to evaluate a new CFT group for people who have had a brain injury and are currently receiving inpatient neuro-rehabilitation. The group will have six weekly sessions with 4-6 people in each group. The group will be run at the inpatient neuro-rehabilitation unit. As this is a new group that has not been run before, it will be a small study to see whether the group is feasible and acceptable to attendees. The study will evaluate whether the group can be run as planned and how many people attend. The investigators will also interview people who attended the group to find out what they thought of the group.

The study also aims to use four questionnaires measuring emotional distress, well-being, self-compassion and quality of life to measure the effect of the group. Group attendees questionnaire scores from before and after the group will be compared to see if there has been any change due to attending the group.

This project is being completed as part of a Doctorate in Clinical Psychology at King's College London, and will be recruiting patients from an inpatient neurorehabilitation setting.

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

  • Has experienced a non-progressive acquired brain injury
  • Is at least 18 years old
  • Has capacity to consent to take part in the group and associated research project
  • Is currently experiencing emotional distress, as identified descriptively by the treating team and indicated by a minimum score of 8 or above (mild symptoms) on the HADS.

排除标准

  • Has a [severe] cognitive impairment to a degree that this is considered by the treating team to prevent their ability to participate in the group despite adaptations.
  • Has a [severe] communication impairment to a degree that is considered by the treating team to prevent their ability to participate in or understand the group content despite adaptations.
  • Is currently experiencing a severe mental health disorder or crisis that would impact on their ability to participate in the group.

研究组 & 干预措施

Compassion focused therapy group

Experimental

6 week compassion focused therapy group for adults with ABI

干预措施: Compassion focused therapy group (Behavioral)

结局指标

主要结局

Practicality - delivery of intervention

时间窗: Weeks 1-6 at each weekly group session

The number of items covered in the session out of the items that were planned in the session guide

Acceptability - patient interview feedback

时间窗: Interview time point after week 6

Feedback from attendees collected via recorded semi-structured interviews after end of intervention

Acceptability - end of session ratings scores

时间窗: Weeks 1-6 at each weekly group session

Patient ratings of enjoyment, understanding and helpfulness using 'Session Rating Form' designed for study

Demand - patients recruited

时间窗: At screening/enrollment

Number of patients recruited to group

Implementation - group sessions completed

时间窗: Weeks 1-6 at each weekly group session

Number of group sessions completed out of 6

Implementation - practice sessions completed

时间窗: Weeks 1-6 at each weekly group session

Number of additional practice sessions completed out of 6

Implementation - patients per group

时间窗: Weeks 1-6 at each weekly group session

Number of patients per group

Demand - patients referred and screened for the group

时间窗: At screening/enrollment

Number of patients referred and screened

Demand - attendance

时间窗: Weeks 1-6 at each weekly group session

Session attendance rate

次要结局

  • Change in self-compassion questionnaire score(2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up)
  • Change in quality of life questionnaire score(2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up)
  • Change in mental well-being questionnaire score(2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up)
  • Change in emotional distress questionnaire score(2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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