Plain English Summary
Background and study aims
Stroke can have a devastating effect on people, not only physically and mentally, but emotionally too. A stroke occurs when the blood supply to the brain is cut off. This research intends to help stroke survivors come to terms with the stroke and prevent depression, a common problem after stroke. Depression affects about one in three stroke survivors. Depressed patients are less motivated to take part in rehabilitation when they are in hospital, resulting in longer hospital stay and poorer recovery.
A type of talking therapy (counselling) called Motivational Interviewing (MI) could be beneficial in helping stroke patients adapt to life after a stroke. The aim of this study is to explore if it MI is a feasible approach to helping patients who have had a stroke.
Who can participate?
Adults aged 18 and older who have had a stroke
What does the study involve?
Participants are randomly allocated to receive either sessions of motivational interviewing (a talking therapy) with a trained therapist, or sessions of attention control which involves spending time with a trained visitor. The sessions are up to an hour long, and held weekly in the participants’ home or in hospital, for up to four weeks. Participant’s complete questionnaires about they are feeling before starting their first session, and again at three months after their stroke.
What are the possible benefits and risks of participating?
Participants may benefit from engaging in either MI or AC sessions by being able to talk to someone individually. Participants may also value being involved in improving psychological support services for future patients. While engaging in MI, participants may become distressed. If therapists or ward staff feel concerned about participants, patient are referred on to an appropriate person with the patient's consent. Should patients disclose information that concerns staff regarding the health and safety of the participant or those around the participant, again the staff member reports this to the lead researcher and the patient is referred to an appropriate person. Participants are made aware of these confidentiality issues before consenting to participate in the study.
Where is the study run from?
Countess of Chester Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2012- November 2015
Who is funding the study?
Northern Stroke Research Fund (UK)
Who is the main contact?
1. Miss Kulsum Patel (Public)
2. Dr Liz Lightbody (Scientific)
Trial website
Contact information
Type
Public
Primary contact
Miss Kulsum Patel
ORCID ID
Contact details
Stroke Research Team
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
Type
Scientific
Additional contact
Dr Liz Lightbody
ORCID ID
http://orcid.org/0000-0001-5016-3471
Contact details
Stroke Research Team
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
105693
Study information
Scientific title
Motivational interviewing for low mood and adjustment early after stroke: A feasibility randomised trial
Acronym
Study hypothesis
The aim of this study is to explore the feasibility of delivering MI using members of the clinical team, and using an attention control, to inform the protocol for a future definitive trial.
Ethics approval
NRES North West Committee - Preston, 31/08/2012, ref: 12/NW/0633
Study design
Mixed methods single centre feasibility study non-blinded parallel-group randomised controlled feasibility trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet’
Condition
Stroke
Intervention
Following completion of baseline assessment, eligible participants are randomised early after stroke on a 1:1 ratio (stratified by response to Yale question “Do you often feel sad or depressed?” Yes or No) to:
1. Motivational Interviewing (MI) [intervention arm],
2. Attention Control (AC) [control arm].
MI is a talking therapy, the techniques of which have been applied to facilitate adjustment after stroke. Participants in the MI group received up to four, hour-long, individual MI sessions held weekly with a trained MI therapist, in hospital or at home.
AC was designed to provide participants with social attention of the same duration and intensity to the MI therapy and involved general conversation and activities not focused on mood (e.g. playing cards). Participants in the AC group receive up to four, hour-long, individual AC sessions held weekly with a trained AC visitor, in hospital or at home.
Participants in both groups are followed up at three months post-stroke.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility of a future definitive trial is measured using:
1. Recruitment and three-month retention of participants, through examination of screening logs and follow up completion;
2. Completeness of data capture in study measures;
3. Acceptability of MI and AC, through interviews with participants;
4. Implementation of MI and AC, through interviews with staff delivering MI and AC;
5. Fidelity to MI and AC, through monitoring of audio recordings of sessions.
Secondary outcome measures
1. Mood is measured using the GHQ12, Yale, DISCs scores at baseline and three months
2. Survival is measured using status (alive/dead) at three months
3. Function is measured using Barthel at baseline and 3 months, and NEADL at three months
4. Quality of life is measured using the EQ5D at three months
5. Adjustment is measured using CIR at three months
6. Community integration is measured using CIQ at three months
Overall trial start date
01/06/2012
Overall trial end date
30/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 or over
2. Medical diagnosis of stroke (from WHO criteria)
3. Medically stable
4. No severe communication difficulties
5. Having capacity to consent
6. No current psychological input
7. Live in hospital catchment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Aged under 18
2. Non diagnosis of stroke (from WHO criteria)
3. Medically unstable
4. Severe communication difficulties
5. Lacking capacity to consent
6. Patient receiving current psychological input
7. Live outside hospital catchment
Recruitment start date
01/12/2012
Recruitment end date
30/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Countess of Chester Hospital
CH2 1UL
United Kingdom
Funders
Funder type
Charity
Funder name
Northern Stroke Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publish results in Pilot and Feasibility Studies. The study protocol is not available online but can be obtained from the study contact on request.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Liz Lightbody, University of Central Lancashire, email: celightbody@uclan.ac.uk
Intention to publish date
30/11/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30263147