Adapting Acceptance and Mindfulness-based Behavior Therapy for Stroke Survivors With Aphasia to Improve Communication Success, Post-stroke Adaptation, and Quality of Life
Phase: NA
Conditions: Stroke, Aphasia
Sponsor: University of Pittsburgh

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Study Protocol  
 
 
 
 
 
 
Official Title: Adapting acceptance and mindfulness-based 
behavior therapy for aphasia 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT04984239 
 
 
 
Protocol Date: 11/4/2020 
 
 
 
 

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Scientific Background 
Post-stroke aphasia has profound and lasting negative effects on health-related quality of life at 
levels greater than cancer, Alzheimer’s disease, or Amyotrophic Lateral Sclerosis. Aphasia is a language 
disorder caused by acquired brain injury that affects 30-40% of stroke survivors and more than 2.5 
million people in the United States. For stroke survivors with aphasia, their psychosocial responses to the 
sudden and unexpected loss of language promote or inhibit their ability to adapt, adjust, and recover after 
stroke.  
To a large extent, practicing rehabilitation professionals are currently unprepared to address the 
relationship between psychosocial adjustment and aphasia rehabilitation. Traditional evidence-based 
language interventions fail to address psychosocial factors, and speech-language pathologists report 
feeling unprepared to address counseling needs during aphasia rehabilitation. In addition, mental health 
professionals report feeling unprepared to work with people with aphasia. Ultimately, workforce training 
based on effective behavioral interventions is required to address the specific unmet needs of this 
vulnerable and underserved population. The first step in this endeavor is to develop and pilot integrated 
interventions that simultaneously address the counseling and communication needs of stroke survivors 
with aphasia.  
The current Stage I project seeks to develop a new intervention will that integrate language 
compensation training and Acceptance and Commitment Therapy (ACT). ACT is a behavioral 
intervention designed to improve psychological flexibility, allowing people to take action consistent with 
their values, even in the presence of persistent emotional distress. Psychological flexibility predicts 
quality of life and mental health in a variety of populations. In small-scale efficacy studies, ACT has 
improved psychological flexibility in stroke survivors, and has resulted in large effect sizes when 
combined with compensatory training in people who stutter. Yet, no prior work has adapted ACT to meet 
the specific needs of people with aphasia, excluding a large and vulnerable subset of stroke survivors 
from accessing an effective intervention.  
ACT is an ideal match for stroke survivors with aphasia and integrating language compensation 
training and ACT is more than the sum of its parts. ACT will only be fully accessible to people with 
aphasia if modified to include communication supports. In addition, language compensation training 
works by training alternative communication techniques (e.g., writing, gesturing, self-cueing) to 
maximize functional communication. However, stroke survivors with aphasia must demonstrate 
psychological flexibility for such training to be effective. They must reconceptualize what it means to 
communicate and overcome potential fears of how they will be perceived. They must become 
comfortable using communication techniques in distressing situations they would rather avoid (e.g., 
communicating with unfamiliar and rude store employees). ACT improves psychological flexibly via 
approaches such as teaching clients to develop a more flexible response repertoire when pursuing valued 
life directions and mindfully gaining distance from self-critical thoughts. Improving communication skills 
and psychological flexibility together will simultaneously address the unmet communication and 
psychosocial needs of stroke survivors with aphasia. 
 
Study Objectives 
Objective: To develop and pilot an “ACT for Aphasia” treatment manual designed to improve 
communication participation, psychosocial adjustment, and quality of life for stroke survivors with 
aphasia. 
Aim 1: Collaborate with a Stakeholder Advisory Board (SAB) to develop and refine an ACT for 
Aphasia treatment manual via an iterative design process. 
We will work with a SAB of stroke survivors with aphasia and caregivers to develop an initial 
version of the manual, then refine it using a successive cohort design. The first cohort will consist 
of 5 participants with aphasia, who will be interviewed after treatment completion. A second 
cohort (N=16) will complete the revised intervention and provide feedback via interviews to 

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inform a second manual revision. This will result in a comprehensive, iteratively refined, 
stakeholder-driven treatment manual. 
 
Aim 2: Establish intervention feasibility and acceptability 
Feasibility will be assessed through intervention adherence, recruitment, participation, and 
completion rates. Acceptability will be assessed using the Client Satisfaction Questionnaire – 8 
post-treatment; ACT for aphasia will be considered acceptable if the group mean is ≥28 for the 
second cohort. As a secondary aim, preliminary effect sizes will also be estimated on pre-post 
measures of successful communication participation, psychological distress, and quality of life, 
along with point estimates and standard deviations to inform power analyses for a Stage II 
efficacy trial. 
 
Study Design & Methods 
Participant assignment: given the early phase of this research and the lack of control conditions or groups, 
there will be no random assignment. Participants will be enrolled in the study as they are referred and 
found to be eligible, with the first five participants being enrolled in the first study cohort during year 1 
while the remainder of participants will be enrolled in the second cohort across years 1 and 2. 
 
**Screening procedures:** 
We will partially assess eligibility prior to informed consent, and finalize screening for eligibility after 
informed consent via interview and standardized assessments. 
 
**Pre-treatment assessments:** 
Participants will be assessed with a primary outcome measure (the Client Satisfaction Questionnaire-8) 
and several secondary outcome measures (screening questions, the Communication Participation Item 
Bank, the Aphasia Communication Outcome Measure-ACOM, the Stroke and Aphasia Quality of Life, 
the Acceptance and Action Questionnaire – ABI, the Kessler K6 non-specific distress scale, the 
Acceptance and Action Questionnaire II, the Modified University of Washington Resilience Scale (added 
for the second study cohort only), and the Comprehensive aphasia test). 
 
Intervention description: the ACT for Aphasia treatment manual will be a 10-session intervention created 
by modifying an existing ACT manual provided by Dr. Meyer. To meet the specific needs of stroke 
survivors with aphasia, ACT will be modified in two main ways. 
 
First, the intervention will include modified language and communication supports to address the unique 
communication challenges faced by people with aphasia that could impede engagement with ACT 
content. Multi-modality communication supports will be provided by the treating clinician (e.g., writing 
out key words to support verbal content, summarizing and providing repetitions, providing session 
summaries to review between sessions). Manual creation will follow existing practice recommendations 
for modifying counseling interventions for PWA (e.g., simplifying language and increasing use of visual 
metaphors) which will be reviewed by the SAB. 
 
Second, ACT will be further augmented via individualized language compensation training and a focus 
on identifying and addressing communication-based barriers to life participation. Language training will 
focus on active compensatory strategies such as self-cuing, use of alternative modalities (gesture, 
writing), and use of commonly available technology (e.g., smartphone dictionaries, text-to-speech). The 
details of this language compensation training will also be determined based on input from the 
Stakeholder Advisory Board (SAB), and will be revised after reviewing performance and interview 
feedback from each successive cohort. 
 

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**Post-treatment phase:** 
In this phase, participants will be given the same series of assessments received in the pre-treatment 
phase. In addition, they will have an interview to provide feedback about the intervention and suggestions 
for improvement. 
 
Post-treatment interviews providing feedback for protocol revision will be administered by trained study 
staff within three weeks of treatment completion. 
 
Interviews will use a semi-structured, ethnographic interview approach and be video-recorded. These 
interviews will ask specific questions about the participant’s experience and perspective regarding each 
functional domain of the intervention (i.e., the “Open Up,” “Be Present,” and “Do What Matters” 
components of ACT and the individualized language compensation training), and will be asked for 
suggestions and improvements about the specific content and techniques employed. 
 
Eligibility Criteria  
Inclusion Criteria: 
Participants will be age 18 or older with an existing diagnosis of aphasia subsequent to left hemisphere 
stroke as confirmed by a) registry referral sources or b) personal copies of medical records (provided by 
the participant following informed consent). 
Exclusion Criteria: 
Exclusionary criteria at enrollment include a history of other acquired or progressive neurological disease, 
significant language comprehension impairments, significant semantic memory impairments, unmanaged 
drug /alcohol dependence, and severe diagnosed mood or behavioral disorders that require specialized 
mental health interventions. 
 
Participants with severe language comprehension impairments will be excluded, as the intervention relies 
on a base level of comprehension to understand instructions and counseling content. Therefore, 
participants will be excluded if their spoken language comprehension mean modality T-score on 
Comprehensive Aphasia Test falls below 40. Furthermore, we will exclude participants with semantic 
memory deficits (8/10) on the Comprehensive Aphasia Test. We will also exclude participants with active 
drug/alcohol dependence and progressive neurological disease such as dementia or primary progressive 
aphasia, as these comorbid factors could affect treatment response and require alternative specialized 
interventions. 
Sample Size Justification 
Given the pilot nature of this study, sample size was chosen to determine acceptability and feasibility of 
our novel intervention without a formal power analysis. 
 
Total sample size (N=21; N=5 for Cohort 1 and N=16 for Cohort 2) is considered to be realistic based on 
level of project staffing and previous experience recruiting PWA in the Pittsburgh area. 
 
The sample size for Cohort 1 was chosen to provide preliminary feedback for the first version of the 
treatment manual. 
 
The sample size for Cohort 2 is considered adequate for providing a precise estimate of treatment 
acceptability. This is because even with an overly conservative attrition rate of 25%, final completion 
rates would still be N=12, which meets minimum recommendations for providing reasonably precise 
confidence intervals for continuous variables (Julious, 2005) 

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Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287-291. 
doi:10.1002/pst.185.