ISRCTN ISRCTN54465472
DOI https://doi.org/10.1186/ISRCTN54465472
Protocol serial number RDO/28/2/16
Sponsor Royal Liverpool University Hospital (UK)
Funder NHS Executive North West (UK) - Health R&D NoW (RDO/28/2/16)
Submission date
09/09/2005
Registration date
21/10/2005
Last edited
12/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Caroline Watkins
Scientific

CPRU
Department of Nursing
University of Central Lancashire
Preston
PR1 2HE
United Kingdom

Phone +44 (0)1772 895140
Email clwatkins@uclan.ac.uk

Study information

Primary study designInterventional
Study designSingle centre randomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesFour sessions of motivational interviewing, given early after stroke, will benefit patientsÂ’ mood at 3 months post-stroke.
Ethics approval(s)Approved by local research ethics committee
Health condition(s) or problem(s) studiedStroke
InterventionUsual 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 typeOther
Primary outcome measure(s)

Mood, assessed by General Health Questionnaire (GHQ-28) at 3 months post-stroke

Key secondary outcome measure(s)

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

Completion date01/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration400
Key inclusion criteria1. 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
Key exclusion criteria1. Known to be moving out of area following discharge
2. Already receiving Psychiatric or Clinical Psychology treatment
Date of first enrolment01/07/2002
Date of final enrolment01/06/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

CPRU
Preston
PR1 2HE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2007 Yes No
Results article results 01/07/2011 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes