Motivational interviewing therapy after stroke
| ISRCTN | ISRCTN17065351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17065351 |
| IRAS number | 261352 |
| Secondary identifying numbers | CPMS 45022, IRAS 261352 |
- Submission date
- 17/01/2022
- Registration date
- 01/02/2022
- Last edited
- 25/03/2024
- Recruitment status
- Recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A stroke occurs when the blood supply to the brain is cut off. A stroke can have a devastating effect on people, not only physically and mentally, but emotionally too. This research intends to help people who have had a stroke come to terms with their stroke and reduce depressive symptoms, a common problem after stroke. Depression affects about one in three stroke survivors. Depressed patients tend to be 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-Based Intervention (MIBI) could be beneficial in helping stroke survivors adapt to life after a stroke. The aim of this study is to determine if MIBI is an effective and cost-effective approach for helping people who have had a stroke.
MIBI will be compared with a sham treatment (Attention Control) where participants spend time with a visitor, to mirror the additional social attention people receive through MIBI. This will help to determine if it is actually the MIBI, or if it is simply spending time with someone, that makes a difference.
Who can participate?
Adults aged 18 years and older who have had a stroke
What does the study involve?
Participants are randomly allocated to receive either: sessions of Motivational Interviewing-Based Intervention (MIBI) which is a talking therapy with a trained therapist plus usual care; or sessions of Attention Control (AC) which involves spending time with a trained AC provider having general conversations plus usual care; or only the usual care available. MIBI and AC sessions are 45 minutes long, and held weekly for up to four weeks, over telephone or video call. Participants complete questionnaires about how they are feeling when they enter the study, and twice more at 6 weeks and 3 months after their stroke.
What are the possible benefits and risks of participating?
Participants may benefit from engaging in either MIBI 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 MIBI, participants may become upset due to talking about their recent stroke and its impact. If MIBI therapists or healthcare staff feel concerned about participants’ wellbeing, they will discuss this with participants, and participants will be referred on to an appropriate person for help. Should participants disclose information that concerns staff regarding the health and safety of the participant or those around the participant, the staff member will report this to the person responsible for their care and the participant will be referred to an appropriate person.
Where is the study run from?
University of Central Lancashire (UK)
When is the study starting and how long is it expected to run for?
September 2019 to July 2025
Who is funding the study?
1. National Institute for Health Research Collaborations for Leadership in Applied Health Research and Care North West Coast (UK)
2. National Institute for Health Research Senior Investigators Award (UK)
3. University of Central Lancashire (UK)
Who is the main contact?
Prof. Liz Lightbody
celightbody@uclan.ac.uk
Contact information
Scientific
Stroke Research Team
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
 ORCID ID |
0000-0001-5016-3471 |
|---|---|
| Phone | +44 (0)1772 893648 |
| celightbody@uclan.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Prevention, Psychological & Behavioural, Complex Intervention, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. |
| Scientific title | COMMITS - Confirming the Mechanism of Motivational Interviewing Therapy after Stroke: a multi-centre randomised controlled trial |
| Study acronym | COMMITS |
| Study hypothesis | The aim of the study is to determine the effect of Motivational Interviewing-Based Intervention (MIBI) on depressive symptoms in people post-stroke. It is hypothesised that MIBI (in addition to usual care) will reduce the number of people with depressive symptoms more so than attention control (in addition to usual care) and usual care alone. |
| Ethics approval(s) | Approved 02/01/2020, Welsh Research Ethics Committee 5, Bangor (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff CF11 9AB, UK; +44 (0)7970 422139; Wales.REC5@wales.nhs.uk), ref: 19/WA/0337 |
| Condition | Stroke |
| Intervention | Current interventions as of 25/03/2024: Following completion of baseline assessment, participants are randomly allocated to one of three groups. Random allocation is on a 1:1:1 ratio, and stratified by site, age (less than 65 years or 65 years and above), and baseline mood (PHQ-9 score of less than 10 or 10 and above). The three groups are: 1. Motivational Interviewing-Based Intervention (MIBI) plus usual care [intervention arm] 2. Attention Control (AC) plus usual care [attention control arm] 3. Usual Care (UC) [control arm] MIBI is a talking therapy that uses techniques to facilitate adjustment after stroke. Participants in the MIBI group receive up to four, 45-minutes long, individual sessions held weekly with a trained MIBI therapist, delivered remotely (telephone or video call). AC is designed to provide participants with social attention of the same duration and intensity to the MIBI therapy. AC involves general conversation not focused on mood. Participants in the AC group receive up to four, 45-minutes long, individual AC sessions held weekly with a trained AC provider, delivered remotely (telephone or video call). UC is available in accordance with national and local guidelines. Participants are not denied any treatment and receive whatever care is usual practice. All participants (in the MIBI, AC and UC groups) receive UC. _____ Previous interventions: Following completion of baseline assessment, participants are randomly allocated to one of three groups. Random allocation is on a 1:1:1 ratio, and stratified by site, age (less than 65 years or 65 years and above), and baseline mood (PHQ-9 score of less than 10 or 10 and above). The three groups are: 1. Motivational Interviewing-Based Intervention (MIBI) plus usual care [intervention arm] 2. Attention Control (AC) plus usual care [attention control arm] 3. Usual Care (UC) [control arm] MIBI is a talking therapy that uses techniques to facilitate adjustment after stroke. Participants in the MIBI group receive up to four, 45-minutes long, individual sessions held weekly with a trained MIBI therapist, delivered remotely (telephone or video call). AC is designed to provide participants with social attention of the same duration and intensity to the MIBI therapy. AC involves general conversation not focused on mood. Participants in the AC group receive up to four, 45-minutes long, individual AC sessions held weekly with a trained AC visitor, delivered remotely (telephone or video call). UC is available in accordance with national and local guidelines. Participants are not denied any treatment and receive whatever care is usual practice. All participants (in the MIBI, AC and UC groups) receive UC. |
| Intervention type | Behavioural |
| Primary outcome measure | Depressive symptoms measured with Patient Health Questionnaire (PHQ-9) at at baseline, 6 weeks and 3 months post-randomisation |
| Secondary outcome measures | 1. Depressive symptoms measured using the Yale single item (“Do you often feel sad or depressed?” Yes or No) at 6 weeks and 3 months; self-reported anti-depressant use (Yes or No) at 3 months; and self-reported psychological input (Yes or No) at 3 months 2. Survival measured using status (alive or dead) at 3 months 3. Anxiety disorder measured using General Anxiety Disorder 7-item at baseline, 6 weeks and 3 months 4. Quality of life measured using Stroke Impact Scale Short-Form at 3 months and the EuroQoL-5 Dimensions, five-level version (EQ-5D-5L) at baseline and 3 months 5. Patients’ resource use measured with a resource use questionnaire at baseline and 3 months 6. Dependence measured using the Modified Rankin Scale at baseline and 3 months 7. Physical function measured using the Barthel Index at baseline and 3 months 8. Further stroke measured using self-report (Yes or No) at 3 months 9. Mediating factors including self-efficacy and confidence measured using the Stroke Self-Efficacy Questionnaire and Confidence after Stroke Measure at 6 weeks and 3 months |
| Overall study start date | 01/09/2019 |
| Overall study end date | 25/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1334; UK Sample Size: 1334 |
| Participant inclusion criteria | 1. Aged ≥18 years 2. Admitted to a participating unit within 28 days of acute stroke 3. Able to provide informed consent 4. Modified Rankin Score (mRS) of 0 – 4 5. None, mild, moderate speech difficulties only (0, 1, 2 or 3 on the CoAT) 6. No known current psychiatric disorder (i.e. not receiving active treatment at the time of screening) 7. Not currently receiving a talk-based therapy 8. PHQ-9: Total Score ≤14 and Q9 Score = 0 9. No current alcohol/drug misuse or dependency 10. Able to converse in English 11. Access to online video conferencing or a telephone to participate in interventions via remote means 12. Does not have a life-threatening/terminal illness 13. Likely to adhere to follow-up procedures |
| Participant exclusion criteria | 1. <18 years 2. Not admitted to a participating unit within 28 days of acute stroke 3. Unable to provide informed consent 4. mRS of 5 5. Moderately severe communication difficulties (4 or 5 on the CoAT) 6. Current psychiatric disorder (i.e. receiving active treatment at time of screening) 7. Currently receiving a talk-based therapy 8. PHQ-9: Total Score ≥15 and/or Q9 Score ≥1 9. Current alcohol/drug misuse or dependency 10. Not able to converse in English 11. No access to online video conferencing or a telephone 12. Has a life-threatening/terminal illness 13. Unlikely to adhere to follow-up procedures |
| Recruitment start date | 01/03/2022 |
| Recruitment end date | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Kendal
LA9 7RG
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Epsom
KT18 7EG
United Kingdom
Sponsor information
University/education
c/o StJohn Crean
Preston
PR1 2HE
England
United Kingdom
| Phone | +44 (0)1772893393 |
|---|---|
| SCrean@uclan.ac.uk | |
| Website | http://www.uclan.ac.uk/ |
"ROR" |
https://ror.org/010jbqd54 |
Funders
Funder type
Government
No information available
No information available
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UCLan
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | A protocol will be available once published. The final results of the study will be published in a peer-reviewed journal following the end of the study and within a year of the overall study end date. Results will also be disseminated widely to participants, patients and the public through social media and lay reports; clinical staff through final reports and presentations; academic community through publication in journals and presentations at conferences; and policy by feeding into the next update of the Intercollegiate Stroke Working Party National Clinical Guideline for Stroke. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. Exact data sharing plans are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/03/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2024 to 25/03/2024.
2. The interventions were changed.
3. The target number of participants was changed from 1200 to 1334.
4. The recruitment end date was changed from 31/12/2023 to 31/07/2025.
5. The intention to publish date was changed from 31/03/2025 to 31/12/2025.
6. The plain English summary was updated to reflect these changes.
17/01/2022: Trial's existence confirmed by the NIHR.
