Clinical trial NCT02131532: A Rehabilitation Therapy for Post-stroke Fatigue
Official title: A Feasibility Study of a Brief Psychological Intervention for Post-stroke Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: Post-stroke fatigue
Psychological intervention
Feasibility
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. Fatigue Assessment Scale
2. Case definition of post-stroke fatigue
3. Nottingham Extended Activities of Daily Living
4. Stroke Impact Scale

Therapy sessions: each participant will be attending six face-to-face sessions over a period of eleven weeks in the hospital. Each session will last for about one hour, where the participant will meet a therapist (a clinical psychologist) of this intervention. With the support from the therapist, the participant will work through an intervention manual to learn skills to overcome their problems related to fatigue, especially for physical activity, mood and sleep. There will be intervals of two weeks between sessions. During the intervals, the participant will be asked to keep a diary to record their daily activities and sleep, to put into action things they have agreed with the therapist (including doing more activity), or to read sections of the intervention manual.

Post-treatment assessment of clinical outcomes: participants will three assessments of clinical outcomes, i.e. immediately after completing all six treatment sessions, one month after treatment, and three-month after treatment.

1. Fatigue (Fatigue Assessment Scale and a case definition of post-stroke fatigue)
2. Depression (Patient Health Questionnaire-9)
3. Independence in daily life (Nottingham Extended Activities of Daily Living)
4. Health-related quality of life (Stroke Impact Scale)

An interim analysis will be performed after one-month assessment and the final analysis will be performed after the three-month assessment. Before- and after- treatment assessments will show whether the intervention is beneficial for the above aspects and whether these benefits could be maintained. The investigator will then write to each participant to inform them of the individual results of both analyses.

Feedback session: at the time of one-month assessment, the participant will be asked to fill a feedback form for their experience of this intervention and the trial. The investigator will analyze the results of this feedback form as well as the results of one-month assessment, and then inform both the participant and the therapist of the individual results. Then the therapist will carry out a feedback session with each participant by telephone (about one hour). During this session, they will discuss the results of assessments and any difficulties that the participant may have experienced in the past month. They will also agree a plan to make further improvement.

Fatigue is a chronic symptom which would require a long term for recovery. Thus this intervention with six treatment sessions is expected to be an intensive initial program for the recovery of post-stroke fatigue, from which participants will learn skills to overcome fatigue-related problems that they can use in daily life. Thus the therapist will encourage participants to continue using these skills in their daily life even after completing the therapy sessions.

Feedback meeting: after all participants have completed their feedback sessions, the investigator will invite them to a feedback meeting. This meeting will be facilitated by the Chief Investigator of this study. At this meeting, participants will share their experience in taking part in this trial, discuss any difficulties they have experienced, and make suggestions to improve this intervention and the trial processes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of Recruitment Process
timeFrame: 3 months after the end of treatment
measure: Attendance of Treatment Sessions
timeFrame: 3 months after the end of treatment
measure: Feasibility of Telephone-delivered Booster Sessions
timeFrame: 3 months after the end of treatment
measure: Feasibility of Follow-up Assessment at Three Months After the End of Treatment
timeFrame: 3 months after the end of treatment
Secondary outcomes:
measure: Fatigue Assessment Scale (FAS)
timeFrame: 3 months after the end of treatment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 months after the end of treatment
measure: Nottingham Extended Activities of Daily Living (NEADL)
timeFrame: 3 months after the end of treatment
measure: Stroke Impact Scale (SIS) - General Rating of Recovery
timeFrame: 3 months after the end of treatment
measure: SIS - Physical Strength
timeFrame: 3 months after the end of treatment
measure: SIS - Memory and Thinking
timeFrame: 3 months after the end of treatment
measure: SIS - Emotion
timeFrame: 3 months after the end of treatment
measure: SIS - Communication
timeFrame: 3 months after the end of treatment
measure: SIS - Daily Activities
timeFrame: 3 months after the end of treatment
measure: SIS - Mobility
timeFrame: 3 months after the end of treatment
measure: SIS - Hand Function
timeFrame: 3 months after the end of treatment
measure: SIS - Social Activity
timeFrame: 3 months after the end of treatment
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
Study officials:
affiliation: Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom
name: Simiao Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu S, Barugh A, Macleod M, Mead G. Psychological associations of poststroke fatigue: a systematic review and meta-analysis. Stroke. 2014 Jun;45(6):1778-83. doi: 10.1161/STROKEAHA.113.004584. Epub 2014 Apr 29.
citation: Duncan F, Wu S, Mead GE. Frequency and natural history of fatigue after stroke: a systematic review of longitudinal studies. J Psychosom Res. 2012 Jul;73(1):18-27. doi: 10.1016/j.jpsychores.2012.04.001. Epub 2012 Apr 29.
citation: Wu S, Mead G, Macleod M, Chalder T. Model of understanding fatigue after stroke. Stroke. 2015 Mar;46(3):893-8. doi: 10.1161/STROKEAHA.114.006647. Epub 2015 Feb 3. No abstract available.
citation: Wu S, Chalder T, Anderson KE, Gillespie D, Macleod MR, Mead GE. Development of a psychological intervention for fatigue after stroke. PLoS One. 2017 Aug 17;12(8):e0183286. doi: 10.1371/journal.pone.0183286. eCollection 2017.