Psychoeducation for Transient Ischaemic Attack and Minor Stroke

NCT ID: NCT02550392

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-01-31

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.

Conditions

Transient Ischaemic Attack; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group psychoeducation

The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) and usual care.

Group Type: EXPERIMENTAL

Psychoeducation

Intervention Type: BEHAVIORAL

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

Control group

Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychoeducation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Stroke Association, United Kingdom

OTHER

Sponsor Role: collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eirini Kontou, PhD DClinPsy

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

TSA PDF 2015-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15079

Identifier Type: -

Identifier Source: org_study_id