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Managing uncertainty and post-traumatic stress symptoms in stroke survivors

Managing uncertainty after a stroke: development and acceptability of a brief psychological trauma-informed intervention to help recognise and reduce post-traumatic stress symptoms in stroke survivors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17836713
Enrollment
249
Registered
2026-02-24
Start date
2026-05-12
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Stroke, Primary sub-specialty: Acute Care

Interventions

The intervention will be developed through the research, following established guidance and the Intervention Mapping approach, and drawing on relevant evidence and expert feedback through discussions
eligibility
carer involvement
additional features
and plans for digitisation. The intervention evaluation is designed to address important uncertainties before moving to potential digitisation and further testing.

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: The key inclusion criteria for stroke survivors in all WPs are: 1. Adults (=18 years). 2. Confirmed diagnosis of first-ever stroke (ischaemic stroke or intracerebral haemorrhage). 3. Within 8-weeks of stroke onset. 4. Has capacity, comprehension, and ability to engage in study procedures/activities. 5. Deemed well enough by their clinician to participate. 6. Able to provide or witness informed consent. The key inclusion criteria for carers in WP2 and WP3 include: 1. Adults (=18 years). 2. Provides regular unpaid care for a stroke survivor who is participating in the study. 3. Spouse, partner, relative, or friend of the stroke survivor. 4. Able to provide written informed consent. The key inclusion criteria for stroke survivors in Study 2 of the PhD research include: 1. Involved in WP1. 2. Agreed to further contact for involvement in future studies. 3. Have capacity, comprehension, and ability to engage in study procedures/activities. 4. Able to provide or witness informed consent.

Exclusion criteria

Exclusion criteria: The key exclusion criteria for stroke survivors in all WPs are: 1. Diagnosis of subarachnoid haemorrhage. 2. Recurrent stroke or a history of stroke. 3. Involved in psychological intervention studies. 4. Serious mental illness currently under psychiatric care. 5. Receiving palliative care. 6. Lacking capacity to provide informed consent or requiring proxy consent. 7. Lives outside the research area. The exclusion criteria for carers in WP2 and WP3 include: 1. Child or adolescent carer (<18-years). 2. Does not provide regular unpaid care for the stroke survivor. 3. Cares for a stroke survivor who is not participating in the study. 4. Paid carer. 5. Lacking the capacity to provide informed consent or requiring proxy consent. 6. Lives outside the research area. The exclusion criteria for stroke survivors in Study 2 of the PhD research include: 1. Has experienced further strokes. 2. Involved in psychological intervention studies. 3. Serious mental illness currently under psychiatric care. 4. Receiving palliative care. 5. Lacking the capacity to provide informed consent or requiring proxy consent.

Countries

England, United Kingdom

Contacts

Public ContactNavneet Aujla
na434@leicester.ac.uk+ 44 (0)1162297801

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026