Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Caroline Watkins
ORCID ID
Contact details
CPRU
Department of Nursing
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
+44 (0)1772 895140
clwatkins@uclan.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDO/28/2/16
Study information
Scientific title
Acronym
Study hypothesis
Four sessions of motivational interviewing, given early after stroke, will benefit patients mood at 3 months post-stroke.
Ethics approval
Approved by local research ethics committee
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Stroke
Intervention
Usual care plus four individual sessions of motivational interviewing (one per week) with the same therapist; each session lasting between 30 and 60 minutes.
Control: usual care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Mood, assessed by General Health Questionnaire (GHQ-28) at 3 months post-stroke
Secondary outcome measures
1. Misery, assessed by Yale single question depression screen
2. Function, assessed by Barthel index
3. Expectations of recovery, assessed by Stroke Expectations Questionnaire (SEQ)
All outcomes assessed at 3 months post-stroke
Overall trial start date
01/07/2002
Overall trial end date
01/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients admitted consecutively to hospital with an acute stroke
2. Over 18 years of age
3. Able to consent (no severe cognitive and communication problems)
4. Willing to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Known to be moving out of area following discharge
2. Already receiving Psychiatric or Clinical Psychology treatment
Recruitment start date
01/07/2002
Recruitment end date
01/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CPRU
Preston
PR1 2HE
United Kingdom
Funders
Funder type
Government
Funder name
NHS Executive North West (UK) - Health R&D NoW (RDO/28/2/16)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17303766
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21700946
Publication citations
-
Results
Watkins CL, Auton MF, Deans CF, Dickinson HA, Jack CI, Lightbody CE, Sutton CJ, van den Broek MD, Leathley MJ, Motivational interviewing early after acute stroke: a randomized, controlled trial., Stroke, 2007, 38, 3, 1004-1009, doi: 10.1161/01.STR.0000258114.28006.d7.
-
Results
Watkins CL, Wathan JV, Leathley MJ, Auton MF, Deans CF, Dickinson HA, Jack CI, Sutton CJ, van den Broek MD, Lightbody CE, The 12-month effects of early motivational interviewing after acute stroke: a randomized controlled trial., Stroke, 2011, 42, 7, 1956-1961, doi: 10.1161/STROKEAHA.110.602227.