A Phase 1/2 interventional study of A brief psychological intervention in Stroke, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-20.
Sponsored by University of Edinburgh · Phase 1/2, Interventional, and Treatment
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.
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:
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 12 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a brief psychological intervention which targets 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. Each participant will meet a therapist in six face-to-face sessions. Each session will be about one hour and be two weeks apart. During the sessions, the participant will discuss with the therapist their problems related to fatigue and work through an intervention manual to learn skills to overcome these problems.
Behavioral: A brief psychological intervention
This intervention is based on the principle of cognitive-behavioral therapy
Feasibility of Recruitment Process
The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.
Time frame: 3 months after the end of treatment
Attendance of Treatment Sessions
Number of participants who completed all treatment sessions.
Time frame: 3 months after the end of treatment
Feasibility of Telephone-delivered Booster Sessions
Numbers of participants who attended the booster session as planned and those who rearranged the session
Time frame: 3 months after the end of treatment
Feasibility of Follow-up Assessment at Three 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.
Time frame: 3 months after the end of treatment
Fatigue Assessment Scale (FAS)
This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study). The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity.
Time frame: 3 months after the end of treatment
Patient Health Questionnaire-9 (PHQ-9)
The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.
Time frame: 3 months after the end of treatment
Nottingham Extended Activities of Daily Living (NEADL)
The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.
Time frame: 3 months after the end of treatment
Stroke Impact Scale (SIS) - General Rating of Recovery
The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.
Time frame: 3 months after the end of treatment
SIS - Physical Strength
The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
SIS - Memory and Thinking
The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
SIS - Emotion
The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
SIS - Communication
The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
SIS - Daily Activities
The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
SIS - Mobility
The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
SIS - Hand Function
The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
SIS - Social Activity
The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: 3 months after the end of treatment
The recruitment was started in July 2014 and completed in October 2014. Participants were recruited through three approaches, including patients discharged from the Stroke Ward, patients visiting the Stroke Clinic, and those visited by the stroke nurses in the community.
| Milestone | Psychological Intervention |
|---|---|
| Started | 12 |
| Completed | 8 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Other health conditions | 2 |
This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study). The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity.
| units on a scale | Intervention Group |
|---|---|
| Fatigue Assessment Scale (FAS) | 17.25 ± 8.56 |
The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.
| units on a scale | Intervention Group |
|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | 5.00 ± 6.32 |
The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.
| units on a scale | Intervention Group |
|---|---|
| Nottingham Extended Activities of Daily Living (NEADL) | 21.00 ± 1.07 |
The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.
| units on a scale | Intervention Group |
|---|---|
| Stroke Impact Scale (SIS) - General Rating of Recovery | 88.63 ± 15.16 |
The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Physical Strength | 89.84 ± 12.47 |
The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Memory and Thinking | 87.05 ± 18.00 |
The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Emotion | 84.38 ± 18.84 |
The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Communication | 87.50 ± 17.91 |
The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Daily Activities | 95.94 ± 5.33 |
The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Mobility | 91.32 ± 13.96 |
The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Hand Function | 95.63 ± 8.63 |
The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.
| units on a scale | Intervention Group |
|---|---|
| SIS - Social Activity | 82.42 ± 19.90 |
The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.
| participants | Intervention Group |
|---|---|
| Initially approached patients | 120 |
| Responding patients | 49 |
| Eligible patients | 20 |
| Consented patients | 12 |
Number of participants who completed all treatment sessions.
| participants | Intervention Group |
|---|---|
| Attendance of Treatment Sessions | 8 |
Numbers of participants who attended the booster session as planned and those who rearranged the session
| participants | Intervention Group |
|---|---|
| Attended as planned | 1 |
| Rearranged | 7 |
Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.
| participants | Intervention Group |
|---|---|
| On time | 6 |
| Delayed | 2 |
Collected over From the beginning to the end of treatment (11 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | — | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Intervention Group |
|---|---|
| Mean | 62.0 ± 14.7 |
| Sex: Female, Male(Participants) | Intervention Group |
|---|---|
| Female | 1 |
| Male | 7 |
| Region of Enrollment(participants) | Intervention Group |
|---|---|
| United Kingdom | 8 |
| Fatigue Assessment Scale(units on a scale) | Intervention Group |
|---|---|
| Mean | 26.5 ± 8.0 |
| Case definition of post-stroke fatigue(participants) | Intervention Group |
|---|---|
| Fulfilling case definition | 5 |
| Not fulfilling case definition | 3 |
| Patient Health Questionnaire-9(units on a scale) | Intervention Group |
|---|---|
| Mean | 7.6 ± 4.3 |
| Nottingham Extended Activities of Daily Living(units on a scale) | Intervention Group |
|---|---|
| Mean | 20.8 ± 0.9 |
| Stroke Impact Scale - General rating of recovery(units on a scale) | Intervention Group |
|---|---|
| Mean | 74.8 ± 16.7 |
8 further baseline measures are reported on the registry.
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