Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
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 stratifie
Sponsors
University of Central Lancashire
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 16/07/2025: 1. Aged =18 years 2. Admitted to a participating unit within 28 days of acute stroke 3. Able to provide informed consent 4. None, mild, moderate speech difficulties only (0, 1, 2 or 3 on the CoAT) 5. No known current psychiatric disorder (i.e. not receiving active treatment at the time of screening) 6. Not currently receiving a talk-based therapy 7. PHQ-9: Total Score =14 and Q9 Score = 0 8. No current alcohol/drug misuse or dependency 9. Able to converse in English 10. Access to online video conferencing or a telephone to participate in interventions via remote means 11. Does not have a life-threatening/terminal illness 12. Likely to adhere to follow-up procedures Previous 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
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 16/07/2025: 1. <18 years 2. Not admitted to a participating unit within 28 days of acute stroke 3. Unable to provide informed consent 4. Moderately severe communication difficulties (4 or 5 on the CoAT) 5. Current psychiatric disorder (i.e. receiving active treatment at time of screening) 6. Currently receiving a talk-based therapy 7. PHQ-9: Total Score =15 and/or Q9 Score =1 8. Current alcohol/drug misuse or dependency 9. Not able to converse in English 10. No access to online video conferencing or a telephone 11. Has a life-threatening/terminal illness 12. Unlikely to adhere to follow-up procedures Previous 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms measured with Patient Health Questionnaire (PHQ-9) at at baseline, 6 weeks and 3 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed