Condition category
Circulatory System
Date applied
08/11/2017
Date assigned
16/11/2017
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Countess of Chester NHS Foundation Trust

Sponsor details

Chester Health Park
Liverpool Road
Chester
CH2 1UL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes