Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia (RCT of an ICAP)

Randomised Controlled Trial of an Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aphasia Following Cerebral Infarction
• Intervention / Treatment: Behavioral: ICAP; Behavioral: Standard Care (in control arm)

Detailed Description

BACKGROUND AND RATIONALE Why is this research needed now? Aphasia is a distressing and increasingly prevalent condition Aphasia is an acquired disorder of language that often persists as a lifelong condition following a brain injury. A stroke is by far the commonest cause, with aphasia experienced by a third of stroke survivors.

In a study of over 66,000 people dependent on others for care, aphasia was rated worse than 75 conditions associated with poor quality of life, including cancer, dementia, quadriplegia, and motor-neurone-disease.

The Stroke Association estimates 350,000 people have post-stroke aphasia in the UK, and this number is set to increase significantly. Although new cases of stroke in high-income countries are decreasing by around 1% per year across all age bands, the aging populations of these countries mean the number of people living with stroke will double by 2035. The prevalence of PWA will thus rise despite the lower incidence of strokes.

Effective speech and language rehabilitation has an increasingly important role to play at a time when the numbers of PWA are rising and receiving ever-fewer resources.

Current speech and language therapy approaches are effective but PWA remain massively under-dosed.

Evidence from meta-analyses of interventional studies on PWA confirms the importance of sufficient therapy dose for achieving clinically meaningful change: a seminal meta-analysis suggested 100 hours; the latest Cochrane review suggests 60-208 hours; and the most recent evidence from the RELEASE project indicates that 3-5 days of therapy per week leads to the greatest gains in overall language and functional communication.

Given this evidence, the challenge is how to deliver sufficiently high doses of contact with expert coaches (therapists) to make a difference to PWA. Although evidence from some aphasia studies supports theoretical claims that spacing out therapy may be beneficial, economic factors have driven a rise in intensive programmes (ICAPs) as a way of providing large doses over short time scales. This is essentially because therapy teams working at single sites are more efficient than peripatetic solo therapists.

The aim of ICAPs is to produce a step-change in language function sufficient to enable PWA to engage more effectively with others and to continue to maintain and even boost any ICAP-related gains in communication.

ICAP DEFINITION AND EVIDENCE The minimum number of contact hours for a service to be considered an ICAP is 3 hours a day for two weeks, i.e. >30 hours in total, which is far more than most community-based PWA ever receive. To date, nine ICAPs that have treated 10 or more PWA have published their findings. In sum, most have demonstrated medium to large effects on key language impairment and functional outcome measures.

Carers count too! The ICAP will specifically target carers of PWA Over half of all PWA depend on support from carers for everyday activities and emotional health. Most carers are spouses, family members, or other close contacts of PWA. Caring for PWA is strongly associated with emotional distress and feeling overburdened.

AIMS, OBJECTIVES AND ENDPOINTS

The investigators will address 3 key gaps in the current evidence base that need resolving before wider implementation of ICAPs can proceed:

1. The investigators will conduct the first ever RCT of an ICAP to test if the clinical effect sizes are as large as observational studies have reported. If ICAPs are to be rolled-out in the NHS, the investigators need to demonstrate what the true effect sizes are by comparing the ICAP with a matched sample of PWA undergoing standard care (reflecting current practices).
2. The investigators will carry out secondary analyses to see if two key PWA variables significantly affect the main result: 1) the age of PWA and 2) time-since-stroke. This will help personalise ICAP provision if either or both variables prove important modulators of therapy effects.
3. By using a high-resolution MRI brain scan prior to therapy, the investigators will provide a mechanistic account of the effects of the ICAP on PWA's speech production and speech comprehension gains. This will enable future stratification of PWAs based on brain imaging.

Clinical Objectives

1. To test whether an ICAP produces a clinically meaningful improvement in PWA's language impairment, communicative ability, mood and quality of life compared with standard care.
2. To measure the quantity and types of intervention that PWA receive in the community (both groups).
3. To investigate whether age and time-since-stroke are significant factors in determining PWAs' response to an ICAP.

Mechanistic Objectives

1. To test whether individual responses to ICAP treatment are predictable, i.e. whether the investigators can best predict individual outcomes based on a person's baseline behaviour and MRI brain scan.
2. To test whether ICAP-driven improvements in language production and comprehension among individual PWA depend on the intactness of different brain regions.

TRIAL DESIGN The ICAP will be evaluated as a 2-arm group RCT across two sites: North London (Queen Square) and South London (St. George's). The comparator will be 'standard care', the quantity and quality of which will be recorded using the Client Service Receipt Inventory.

Allocation to these groups will be on a 1:1 ratio. To ensure the groups do not become unbalanced the investigators will use stratified randomisation based on two factors: aphasia severity and time-since-stroke. The allocation will be balanced at each site and will be carried out by the Bangor Clinical Trials Unit.

INTERVENTIONS Experimental intervention (ICAP) As defined by the new framework commissioned by the NIHR and the MRC, ICAPs are complex interventions with multiple interacting components. The investigators 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.

PWA will be grouped into roughly-matched cohorts of 4 (based on aphasia severity). As 'day attenders' they will participate 09:00-17:00 for 4 days a week for 4 weeks, engaging for up to 6 hours a day. Some PWA will travel from home each day. Those who cannot manage this will stay 3 nights a week in a local hotel offering accessible rooms.

The aim is to provide ~100 hours of therapy. The content will involve patient and family education, individual goal-setting, impairment and activity-based therapy (language and communication), conversation-partner training, and facilitative strategies for communication. The interventions will be delivered using a variety of approaches, including individual and paired sessions, group sessions, independent practice (including therapy apps), and sessions with PWA and their family members.

The ICAP will also include a clinical psychology-led forum called Carers' Café to support nominated carers of PWA in adjusting and adapting to the changes they are experiencing. The group will meet weekly and follow the principles of Acceptance and Commitment Therapy. Themes will include 'letting go of the struggle', 'increasing mental flexibility', 'unhooking from the pain and loss', and acknowledging the strain that sometimes accompanies this role. During the ICAP, weekly 1-hour sessions will be held face-to-face where possible, or hybrid if not. The ICAP is an intensive experience for carers and they will need help in providing continued support for the PWA's recovery trajectory after discharge. Accordingly, 4 more weekly remote sessions of Carers' Café will be held following the ICAP to support ongoing adjustment and to establish a legacy of peer support.

Control (standard care) 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) the investigators will ensure the research team complete the relevant sections of the Client Service Receipt Inventory at each time point.

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Leff, PhD; Phone Number: +442076791129; Email: a.leff@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N3AZ
    • UCL Queen Square Institute of Neurology
    • Contact: Alex Leff, PhD; Phone Number: +442076791129; Email: a.leff@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Comprehensive Aphasia Programme; 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; 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.
Active Comparator: Control (standard care); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive Aphasia Test	Language impairment: this test is scalar and tests multiple language domains: speech production, auditory comprehension, reading and writing. Higher score = better performance. Raw scores are transformed into T-Scores to compare across domains. Min score is 25 and max score is 75.	Baseline, 1-month, 4-month and 9-month post treatment-allocation
Communicative Effectiveness Index	Functional Communication: The Communicative Effectiveness Index is a 16-item questionnaire designed to assess the functional communication abilities of people with aphasia, typically rated by carers on a 10-cm visual analogue scale (0-100 mm) for each item. Maximum and Minimum Scores Minimum Score (Lowest Performance): 0, indicating "not able at all". Maximum Score (Best Performance): 100	Baseline, 4-month and 9-month post treatment-allocation
Communicative Participation Item Bank	Confidence measure: For the 10-item Communicative Participation Item Bank (CPIB) General Short Form, the raw summary scores range from 0 to 30. Key scoring details for the 10-item short form: Minimum Score (0): Indicates maximum interference in communication participation (most severe restriction). Maximum Score (30): Indicates no interference in communication participation (no restriction). Scoring System: "Not at all" = 3, "A little" = 2, "Quite a bit" = 1, "Very much" = 0.	Baseline, 1-month, 4-month and 9-month post treatment-allocation
Stroke Aphasic Depression Questionnaire	Measure of mood: The Stroke Aphasic Depression Questionnaire (SADQ) Minimum Score: 0 Maximum Score: 63 Description: 21 items completed by a caregiver, with higher scores indicating higher levels of depression.	Baseline, 4-month and 9-month post treatment-allocation
General Health Questionnaire-12	psychological well-being: The General Health Questionnaire-12 uses a Likert scale (0-1-2-3). Minimum Score: 0 Maximum Score: 36 Higher scores indicate greater psychological distress. A typical range for low distress is 0-12, moderate 13-19, and high 20-36.	Baseline, 4-month and 9-month post treatment-allocation
Goal Assessment Scale	Short, medium, long-term and economic goals: The Goal Attainment Scale uses a 5-point ordinal scale, ranging from -2 to +2 to measure the extent to which individual goals are achieved. GAS Score Levels: 2: Much more than expected (Best possible outcome); 1: Somewhat more than expected 0: Expected level of outcome (Target goal)1: Somewhat less than expected (Less than expected)2: Much less than expected (Baseline or worse)	Baseline, 1-month, 4-month and 9-month post treatment-allocation
Client Service Receipt Inventory	Utilization of health, social, and community services: It is not scale, rather it is an inventory capturing the frequency and duration of medical service utilization over a specific, retrospective period (last 4 weeks).	Baseline, 1-month, 4-month and 9-month post treatment-allocation
Adult Carers Quality Of Life Questionnaire	Carer quality of life: The Adult Carer Quality of Life Questionnaire has a total possible score range of 0 to 120, with higher scores indicating a better quality of life. The questionnaire consists of 40 items across eight subscales, with each subscale having a maximum score of 15. Total Score Ranges Maximum Score: 120 (highest quality of life) Minimum Score: 0 (lowest quality of life) Interpretation of Total Scores 0-40: Low reported quality of life (may suggest problems or difficulties) 41-80: Mid-range reported quality of life 81+: High reported quality of life	Baseline, 4-month and 9-month post treatment-allocation
Zarit Burden Interview	Carer burden: The Zarit Burden Interview is a widely used instrument to measure the caregiver burden, with the full, original version containing 22 items. The scores range from 0 (minimum = low burden) to 88 (maximum = high burden). Zarit Burden Interview (22-Items) Scoring Minimum Score: 0 (No/little burden) Maximum Score: 88 (Severe burden) Item Scoring: Each of the 22 items is assessed on a 5-point Likert scale (0 to 4), ranging from 'never' to 'nearly always'. General Score Interpretation (22-Item) 0-21: Little or no burden 21-40: Mild to moderate burden 41-60: Moderate to severe burden 61-88: Severe burden	Baseline, 4-month and 9-month post treatment-allocation
Patient Health Questionnaire-9	Psychological well-being: The Patient Health Questionnaire-9 has a total score range of 0 to 27. Minimum Score: 0 (indicates no symptoms reported) Maximum Score: 27 (indicates severe depression) Scoring Breakdown Each of the 9 items is scored on a scale of 0 to 3: Not at all = 0 points Several days = 1 point More than half the days = 2 points Nearly every day = 3 points Severity Interpretation 0-4: Minimal or no depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression	Baseline, 4-month and 9-month post treatment-allocation
ICAP Questionnaire for Person With Aphasia	We're going to ask you some questions about your experience of being a participant on this trial.; How was your experience on this trial?; Are there things you think that you have gained from being on this trial?; Where there any challenges to being a participant on this trial?a. If yes then can you tell me about them.; Is there anything that you would have wanted us to do differently?; What would have made this a better experience?; Has being on this trial changed you in any way?If yes then what areas of your life has it changedIf no, what would have helped make a positive change; Do you thing being in this trial had an impact on your close others (family or carers)?; Would you recommend this experience to someone else with Aphasia?	9 months (final time point)
ICAP Questionnaire For the carers	How was your experience on this trial of being a carer How was the PWA's experience of being in this trial? Are there things you think that you have gained from being on this trial, if any? What are the things that you think the PWA gained from being on this trial, if any. Where there any challenges to being a participant on this trial? a. If yes then can you tell me about them. Where there any challenges to the PWA being on this trial? a.If yes then can you tell me about them. Is there anything that you would have wanted us to do differently? What would have made this a better experience? Has being on this trial changed you in any way?; If yes then what areas of your life has it changed; If no, what would have helped make a positive change Has being on this trial changed the person with Aphasia in any way? a.If yes then what areas of your life has it changed b.If no, what would have helped make a positive change Do you think being in this trial had an impact on your close others	9 months (final time point)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews	With both PWA and carers	9-months

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University College London Hospitals; City, University of London; St George's University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ICAP; PWA; Intensive Comprehensive Aphasia Programme; People With Aphasia
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 177373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: An anonymised data set will be made available for other researchers to request access to for perpetuity.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No