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Psychoeducation for Transient Ischaemic Attack and Minor Stroke

Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02550392
Acronym
OPTIMISM
Enrollment
64
Registered
2015-09-15
Start date
2016-03-31
Completion date
2020-01-31
Last updated
2020-03-25

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

Conditions

Stroke, Transient Ischaemic Attack

Brief summary

Transient Ischaemic Attack (TIA), also called 'ministroke' is characterised by shortlasting symptoms that generally do not cause permanent damage. 'Minor stroke' is a term used to describe a stroke with mild and nondisabling symptoms. TIA and minor stroke patients account for more than half of all cases of stroke and they are at a higher risk to suffer a major stroke. Currently, management of TIA/minor stroke patients is mainly focused on identifying and reducing risk factors for a later stroke. However, people after a TIA often have limited access for further specialist support from stroke-specific rehabilitation services. Although there is variability in the level of recovery and severity of symptoms after TIA and minor stroke, there is evidence that these patients may experience difficulties that affect their quality of life including anxiety and depression. This study aims to develop, tailor and target the delivery of a time-limited group intervention that offers educational, psychological and social support for people following TIA and minor stroke. A qualitative study (Phase 1) will be conducted with service users and experts working with people with TIA/minor stroke to develop the psychoeducational intervention. Following this, we will conduct a feasibility randomised controlled trial in one centre (Phase 2) to explore whether this group psychoeducational intervention for people after TIA and minor stroke carers is acceptable and to determine the feasibility of the proposed evaluation and the sample size needed in a definite trial.

Detailed description

Participants will complete measures at baseline and then randomly allocated to receive the intervention or usual care. The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) in addition to self-help leaflets and usual care. It is anticipated that the intervention will be offered in 6 two-hour sessions over 3 months by an assistant psychologist. The control group will receive usual care plus self-help leaflets on relevant topics. All participants will complete outcome measures at 3 and 6 months after randomisation. We will test the feasibility, tolerability and acceptability of delivering the intervention and will record data on study completion and attrition. Findings will inform the development of a larger trial and will determine if the content and delivery of the intervention meets the needs of people after TIA and minor stroke.

Interventions

BEHAVIORALPsychoeducation

A time-limited group psychoeducational intervention that will aim to offer educational, psychological and social support.

Sponsors

The Stroke Association, United Kingdom
CollaboratorOTHER
Nottingham University Hospitals NHS Trust
CollaboratorOTHER
University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults with a first/recurrent TIA or minor stroke; * identified within 6 months of their diagnosis; * who are independent with activities of daily living; * who consent to take part

Exclusion criteria

* diagnosis of dementia; * receiving psychological interventions for mental health difficulties immediately prior to their TIA/minor stroke, visual or hearing impairments that would impact on ability to complete baseline assessments; * cognitive or communication difficulties that would impact on ability to complete baseline assessments and to participate in group sessions; * unable to communicate in English.

Design outcomes

Primary

MeasureTime frame
Number of participants recruited to the trialup to 1 year
Number of participants who completed the trialparticipants will be followed for the duration of the trial, an expected average of 12 months

Secondary

MeasureTime frameDescription
Moodbaseline, 3 and 6 months follow-upGeneral Health Questionnaire-30 (GHQ-30)
Health-related Quality of Lifebaseline, 3 and 6 months follow-upEuroQuol-5D
Knowledge and Satisfactionbaseline, 3 and 6 months follow-upKnowledge and Satisfaction Questionnaire

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026