A Feasibility Study of a Brief Psychological Intervention for Post-stroke Fatigue
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment Process
研究概览
简要总结
Stroke is a leading cause of adult disability in the community. Fatigue affects about a third of stroke survivors. It results in difficulty taking part in everyday activities, and increases risk of hospitalization and death after stroke. Despite of its high prevalence and distressing consequences, there is no effective treatment.
Psychological interventions have improved fatigue in patients with other conditions such as multiple sclerosis. These interventions primarily target patients' beliefs about overcoming fatigue and their physical activities in daily life. Also studies indicated that post-stroke fatigue is associated with mood. Based on this knowledge, the investigator has designed a brief psychological intervention for post-stroke fatigue.
The current study is a feasibility study to test the adequacy of intervention manuals and the feasibility of trial processes. This study will need 12 stroke survivors who have post-stroke fatigue and are over three months but within two years after their stroke. Stroke survivors with severe depression or having insufficient capability in cognition or communication will not be included. The investigator will check their eligibility by questionnaires and interviews and then invite eligible people to take part in the study.
This intervention will be delivered by a therapist (a clinical psychologist) to each participant through six face-to-face therapy sessions. Each session will be about one hour and be two weeks' apart. During the sessions, participants will discuss with the therapist their fatigue problems, and, with the support from the therapist, work out ways to solve their problems. One month after the last face-to-face session, each participant will receive a feedback session by telephone from the therapist. Each participant will be followed up to three months after the last face-to-face session.
After all participants complete their feedback sessions, the investigator will invite them to a group meeting to share their experiences of taking part in this trial and makes suggestions as how their experiences of this intervention, and also of this trial, could be improved.
详细描述
This is a feasibility study to test a brief psychological intervention for post-stroke fatigue. 12 stroke survivors with post-stroke fatigue will be recruited for this study. This intervention has been adapted from similar interventions that have improved fatigue in other conditions, such as multiple sclerosis, cancer and chronic fatigue syndrome. Like in other conditions, fatigue in stroke survivors is associated with low mood, people's beliefs about overcoming fatigue, and reduced physical activity. This intervention will target patients' mood, their beliefs about their ability to overcome fatigue, and the scheduling of daily activities, with an aim to increase physical activities in daily life and finally reduce the level of fatigue.
Following the relevant guideline of the United Kingdom (UK) Medical Research Council, the investigators will perform a sequence of trials to test the feasibility, safety and effectiveness of this intervention. Current study is an initial stage to test the feasibility of the intervention, i.e. whether this brief psychological intervention could be adequately delivered to people with post-stroke fatigue on an individual basis. To standardize the therapeutic components of this psychological intervention, this intervention will be delivered by a clinical psychologist in the current study. In subsequent trials, the intervention will then be adapted to be delivered by stroke nurses, which is a more practical situation within the National Health Service of the United Kingdom.
Check for eligibility and consent for participation: the investigator will send mails to stroke survivors who had a stroke between the past three to 24 months to invite them to take part in a survey for post-stroke fatigue and depression. For those who have post-stroke fatigue and do not have severe depression, they will be invited to a face-to-face meeting with the investigator. At this meeting, the investigator will further check the eligibility of each potential participant and answer his/her questions about this study. If the potential participant is willing to take part in the trial, him/her will be asked to sign a consent form for participation.
Baseline assessment of clinical outcomes: after signing the consent, the participant will be asked to complete four questionnaires for baseline assessment:
- Fatigue Assessment Scale
- Case definition of post-stroke fatigue
- Nottingham Extended Activities of Daily Living
- Stroke Impact Scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Had a clinical diagnosis of stroke in the past three to 24 months (including minor stroke)
- •Have post-stroke fatigue
- •Over 18 years old
- •Live in the Lothian area, Scotland
排除标准
- •Have severe depression (with a total score of the Patient Health Questionnaire-9 of 15 or more)
- •Have severe cognitive deficits
- •Have severe aphasia
- •Have significant difficulty in verbal communication
- •Medically unstable or have another unfavorable condition that could impact results (e.g. substance abuse)
- •Being in the nursing home
- •Currently in another research study that might affect fatigue or add significant burden to participants, e.g. studies have outcome measures for fatigue or involve physical training
结局指标
主要结局
Feasibility of Recruitment Process
时间窗: 3 months after the end of treatment
The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.
Feasibility of Telephone-delivered Booster Sessions
时间窗: 3 months after the end of treatment
Numbers of participants who attended the booster session as planned and those who rearranged the session
Attendance of Treatment Sessions
时间窗: 3 months after the end of treatment
Number of participants who completed all treatment sessions.
Feasibility of Follow-up Assessment at Three Months After the End of Treatment
时间窗: 3 months after the end of treatment
Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(3 months after the end of treatment)
- Stroke Impact Scale (SIS) - General Rating of Recovery(3 months after the end of treatment)
- SIS - Physical Strength(3 months after the end of treatment)
- SIS - Communication(3 months after the end of treatment)
- SIS - Mobility(3 months after the end of treatment)
- SIS - Hand Function(3 months after the end of treatment)
- Nottingham Extended Activities of Daily Living (NEADL)(3 months after the end of treatment)
- SIS - Memory and Thinking(3 months after the end of treatment)
- SIS - Daily Activities(3 months after the end of treatment)
- SIS - Social Activity(3 months after the end of treatment)
- Fatigue Assessment Scale (FAS)(3 months after the end of treatment)
- SIS - Emotion(3 months after the end of treatment)