Motivational interviewing for low mood after stroke

ISRCTN ISRCTN55624892
DOI https://doi.org/10.1186/ISRCTN55624892
Protocol serial number 105693
Sponsor Countess of Chester NHS Foundation Trust
Funder Northern Stroke Research Fund
Submission date
08/11/2017
Registration date
16/11/2017
Last edited
01/10/2018
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

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)

Contact information

Miss Kulsum Patel
Public

Stroke Research Team
University of Central Lancashire
Preston
PR1 2HE
United Kingdom

Dr Liz Lightbody
Scientific

Stroke Research Team
University of Central Lancashire
Preston
PR1 2HE
United Kingdom

ORCiD logo 0000-0001-5016-3471

Study information

Primary study designInterventional
Study designMixed methods single centre feasibility study non-blinded parallel-group randomised controlled feasibility trial
Secondary study designRandomised parallel trial
Study type Participant information sheet
Scientific titleMotivational interviewing for low mood and adjustment early after stroke: A feasibility randomised trial
Study objectivesThe 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(s)NRES North West Committee - Preston, 31/08/2012, ref: 12/NW/0633
Health condition(s) or problem(s) studiedStroke
InterventionFollowing 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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

Completion date30/11/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2012
Date of final enrolment30/11/2013

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Countess of Chester Hospital
CH2 1UL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
IPD sharing planThe 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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 25/09/2018 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

01/10/2018: Publication reference added.

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