Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia

NCT07386652 | Not Yet Recruiting DMC

• 1 other identifier: 177373
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

Research question Does participation in an Intensive Comprehensive Aphasia Programme produce a meaningful change in the communication of people with aphasia, their quality of life and that of their carers? Background Aphasia is a persistent language disorder that severely impairs communicative abilities. Most commonly induced by a stroke, aphasia reduces quality of life more than any other condition. People with aphasia (PWA) and their carers feel abandoned by the NHS due to the limited treatment options available. Meanwhile, neuroscientific evidence suggests that PWA can make meaningful gains in communicative ability, mood, and quality of life if therapists are given enough time to work with them. Although studies indicate Intensive Comprehensive Aphasia Programmes (ICAPs) are effective ways to deliver such therapy, no randomised controlled trial (RCT) of an ICAP has yet been conducted. the investigators propose conducting the first ever ICAP RCT. Aims and objectives Clinical: i) To test the efficacy of an ICAP in improving PWAs' language impairment, communicative ability, mood, and quality of life; ii) to measure the quantity and quality of therapy received in the community by the standard care group; iii) to assess the significance of age and time-since-stroke in PWA's responses to ICAP intervention. Mechanistic: To test whether combining baseline behaviour and MRI brain scans can usefully predict individual patients' responses to the ICAP treatment. Methods The RCT will test the effect of an ICAP intervention by randomly assigning PWA and their carers to one of two groups receiving either ICAP or standard care at two participating sites. The investigators aim to deliver 100 hours of ICAP therapy over a 4-week schedule to adult PWA who are more than 3 months post-stroke. The investigators will compare the effects of the ICAP, comprising complex interventions with multiple interacting therapeutic components, with standard care, the quantity and quality of which will be recorded by research assistants. The primary outcome measure is a standardized scale for measuring quality of life for PWA (SAQOL-39g). The primary endpoint is 4 months post-randomisation. The investigators will also test for effects at 9 months. Anticipated impacts The trial could provide the evidence needed to transform how the NHS treats PWA and their carers. If the investigators demonstrate that participating in an ICAP leads to clinically meaningful and sustained improvements, the next stage in achieving wider NHS roll-out will be a multi-centre trial to investigate the cost- and clinical effectiveness of ICAPs across the UK.

Conditions

Aphasia Following Cerebral Infarction

Keywords

Intensive Comprehensive Aphasia Programme; ICAP; People With Aphasia; PWA

Outcome Measures

Primary Outcomes (2)

• Stroke and Aphasia Quality of Life Scale-39

  The primary outcome measure will be a standardized scale for measuring quality of life for PWA. The primary endpoint is at 4 months, i.e. 3 months post-ICAP. Likert scale (1-5 for each question). High scores = better outcome. The main score is reported as an average of all scores but there are three subscales: Communication, psychosocial and physical. The investigators expect changes in communication and psychosocial but not physical subscores. Min = 1, Max = 5

  Four months post allocation to interventio or control arm.

• Structural MRI brain scan

  By using a high-resolution MRI brain scan prior to therapy, we will provide a mechanistic account of the effects of the ICAP on PWA's speech production and speech comprehension gains.

  Four months post treatment-allocation

Secondary Outcomes (12)

• Comprehensive Aphasia Test

  Baseline, 1-month, 4-month and 9-month post treatment-allocation

• Communicative Effectiveness Index

  Baseline, 4-month and 9-month post treatment-allocation

• Communicative Participation Item Bank

  Baseline, 1-month, 4-month and 9-month post treatment-allocation

• Stroke Aphasic Depression Questionnaire

  Baseline, 4-month and 9-month post treatment-allocation

• General Health Questionnaire-12

  Baseline, 4-month and 9-month post treatment-allocation

Study Arms (2)

Intensive Comprehensive Aphasia Programme

EXPERIMENTAL

As defined by the new framework commissioned by the NIHR and the MRC \[44\], ICAPs are complex interventions with multiple interacting components. We have published our ICAP operating manual using the TIDieR format (Template for Intervention Description and Replication) to ensure it complies with intentionally accepted requirements (see uploads) \[45, 46\] Accordingly, no individual PWA or their carer will receive all possible therapeutic components; instead, the therapists will personalise content according to individual needs to help them achieve their goals. A further key feature of the ICAP is that the treating therapists (4 Speech and Language Therapists and one Clinical Psychologist) work as a team, meaning all of them will work with each PWA over the 4-week ICAP.

Behavioral: ICAP

Control (standard care)

ACTIVE COMPARATOR

Although the amount of therapy received by PWA in the community varies, the most in-depth study of this variation across 21 UK-based SLT departments concludes as follows: "Where resources are in short supply, therapists have the difficult ethical decision of providing therapeutic levels of intervention to some patients, or providing sub therapeutic levels to all. Currently it looks as if the latter is most common in practice."\[48\] This study found the majority of PWA over a year post-stroke were not receiving any therapy, while a minority were receiving \~6.3 hours, ranging widely from 0.5-41.5 hours. To capture the quantity and quality of the therapy received by PWA in this arm (and the ICAP group once they complete the ICAP) we will ensure the research team complete the relevant sections of the Client Service Receipt Inventory at each time point

Behavioral: Standard Care (in control arm)

Interventions

ICAP BEHAVIORAL

As defined by the new framework commissioned by the NIHR and the MRC \[44\], ICAPs are complex interventions with multiple interacting components. We have published our ICAP operating manual using the TIDieR format (Template for Intervention Description and Replication) to ensure it complies with intentionally accepted requirements (see uploads) \[45, 46\] Accordingly, no individual PWA or their carer will receive all possible therapeutic components; instead the therapists will personalise content according to individual needs to help them achieve their goals. A further key feature of the ICAP is that the treating therapists (4 Speech and Language Therapists and one Clinical Psychologist) work as a team, meaning all of them will work with each PWA over the 4-week ICAP.

Intensive Comprehensive Aphasia Programme

Standard Care (in control arm) BEHAVIORAL

Although the amount of therapy received by PWA in the community varies, the most in-depth study of this variation across 21 UK-based SLT departments concludes as follows: "Where resources are in short supply, therapists have the difficult ethical decision of providing therapeutic levels of intervention to some patients, or providing sub therapeutic levels to all. Currently it looks as if the latter is most common in practice."\[48\] This study found the majority of PWA over a year post-stroke were not receiving any therapy, while a minority were receiving \~6.3 hours, ranging widely from 0.5-41.5 hours. To capture the quantity and quality of the therapy received by PWA in this arm (and the ICAP group once they complete the ICAP) we will ensure the research team complete the relevant sections of the Client Service Receipt Inventory at each time point.

Control (standard care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years old) PWA caused by stroke
• More than 3 months post-stroke
• Can use English to communicate (even if not as their first language)
• Carers will be nominated (if available) by individual PWA

You may not qualify if:

• Severe speech apraxia (no meaningful spoken word output)
• Severe fatigue or other reasons they cannot commit to the timing and duration of the ICAP
• Ongoing debilitating psychiatric disorders (e.g. psychosis, but not low mood)
• Co-existing neurological disorders affecting engagement (e.g. dementia).

Sponsors & Collaborators

• University College London Hospitals: collaborator
• City, University of London: collaborator
• University College, London: lead
• St George's University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

UCL Queen Square Institute of Neurology

London, WC1N3AZ, United Kingdom

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Alex Leff, PhD

CONTACT

+442076791129; a.leff@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)