Condition category
Circulatory System
Date applied
09/09/2005
Date assigned
21/10/2005
Last edited
12/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.uclan.ac.uk/facs/health/nursing/research/groups/stroke/ongoing%20projects/motivinterview.htm

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 patientsÂ’ 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 measures

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

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

Sponsor information

Organisation

Royal Liverpool University Hospital (UK)

Sponsor details

Research and Development
4th Floor
Linda McCartney Centre
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes