Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia

Adapting Acceptance and Mindfulness-based Behavior Therapy for Stroke Survivors With Aphasia to Improve Communication Success, Post-stroke Adaptation, and Quality of Life

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04984239

Enrollment

Registered

2021-07-30

Start date

2021-11-02

Completion date

2024-01-22

Last updated

2025-04-25

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

Conditions

Aphasia, Stroke

Keywords

Counseling, Therapeutics

Brief summary

The proposed study is a Stage I successive cohort trial intended to adapt Acceptance and Commitment Therapy (ACT) to meet the specific needs of stroke survivors with aphasia (ACT for Aphasia). It will do so by incorporating communication supports and compensatory speech-language treatment. The goal of developing this integrated treatment is to improve successful communication participation, psychosocial adjustment, and quality of life for stroke survivors with aphasia. In the first phase of the project, the investigators will create a treatment manual with input from a stakeholder advisory board consisting of caregivers and stroke survivors with aphasia. The investigators will then recruit an initial cohort of five stroke survivors with aphasia to undergo the initial version of the treatment based and provide feedback. This will aid revision of the manual, which the investigators will then evaluate using a second cohort of 16 stroke survivors with aphasia. The investigators predict that ACT for Aphasia will be acceptable and feasible based on measures of participant satisfaction and treatment adherence. The investigators will also measure pre- to post-treatment changes in psychological distress, functional disability, quality of life, and communication participation and functioning to establish preliminary effect size estimates for this intervention, in preparation for a subsequent Stage II efficacy trial.

Detailed description

The overarching goals of this research are to improve psychosocial adjustment, quality of life, and successful communication participation by developing Act for Aphasia, a patient-centered, manualized behavioral intervention in Stage I research. Stroke survivors with aphasia will complete a 10-session intervention. In study Aim 1, the investigators will engage a Stakeholder Advisory Board (SAB) of people with aphasia (PWA) and caregivers to provide input to develop a treatment manual. The investigators will then use an iterative design process and two successive participant cohorts to refine the manual. Cohort 1 (N=5) will participate in the initial version of the treatment, then help inform its revision by being invited to join the SAB. Cohort 2 (N=16) will participate in the revised version. In Aim 2a the investigators will establish feasibility and acceptability of this intervention. In Aim 2b the investigators will estimate preliminary effect sizes for a subsequent Stage II efficacy trial. 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. 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 SAB, and will be revised after reviewing performance and interview feedback from each successive cohort. Intervention administration procedures: all aspects of the treatment protocol will be administered by Dr. Evans or a licensed speech-language pathologist on study staff who has received training in providing ACT. The intervention will consist of 10 weekly treatment sessions. Post-treatment interviews providing feedback for protocol revision will be administered by Dr. Evans within 2 weeks of study 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. Note that the values tracker measure was formally removed from the outcome measures in the study protocol. The protocol was modified to administer the values tracker informally during the treatment phase to help clinicians monitor progress and to guide in-session treatment discussions about value-based goal setting.

Interventions

BEHAVIORALAcceptance and Commitment Therapy for aphasia

The intervention will consist of Acceptance and Commitment Therapy modified to meet the needs of stroke survivors with aphasia, combined with communication strategy training.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants will be age 18 or older. * Participants will have an existing diagnosis of aphasia subsequent to left hemisphere stroke.

Exclusion criteria

* Participants with a history of other acquired or progressive neurological disease. * Participants whose mean modality t-score falls below 40 on the spoken language comprehension subdomain of the Comprehensive Aphasia Test. * Participants with semantic memory impairments as determined by the cutoff of the semantic memory component of the Comprehensive Aphasia Test. * Participants with unmanaged drug /alcohol dependence. * Participants with severe diagnose.d mood or behavioral disorders that require specialized mental health interventions

Design outcomes

Primary

Measure	Time frame	Description
Mean Scores on the Client Satisfaction Questionnaire - 8	Post-treatment (within one week of completing the treatment phase)	The Client Satisfaction Questionnaire - 8 (CSQ-8) is a brief questionnaire demonstrated to provide efficient, sensitive, and reasonably comprehensive measures of patient satisfaction. It has 8 questions rated on a 4-point scale (summed scores range from 8 to 32). High scores indicate high satisfaction and low scores indicate low satisfaction. The CSQ-8 is the primary measure which will determine acceptability of the proposed pilot intervention.

Secondary

Measure	Time frame	Description
Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury	Baseline and Post-Treatment (within one week of completing the treatment phase)	The Acceptance and Action Questionnaire - Acquired Brain Injury (ACQ-ABI) is a 15 item self-report measure adapted from the ACQ-II specifically for people with acquired brain injury based on a 5-point Likert scale ranging from 15-75 where higher scores indicate greater levels of acceptance. While the ACQ-II addresses psychological flexibility generally, the ACQ-ABI measures psychological flexibility relating specifically to the consequences of acquired brain injury and is therefore an informative addition. Similar to the ACQ-II, it will also evaluate changes in psychological flexibility, the hypothesized mechanism of action underlying ACT for aphasia.
Mean Scores on the Kessler K6 Non-specific Distress Scale	Baseline and Post-Treatment (within one week of completing the treatment phase)	The Kessler K6 is a brief, validated instrument that assesses non-specific psychological distress experienced over the past 30 days. It has 6 items rated on a 0 to 4-point scale (summed scores range from 0 to 24). Higher total scores reflect greater psychological distress.
Mean Scores on the Stroke and Aphasia Quality of Life Scale	Baseline and Post-Treatment (within one week of completing the treatment phase)	The Stroke and Aphasia Quality of Life Scale is a 39-item patient reported measure of qualify of life adapted specifically for people with aphasia from the stroke survivor quality of life scale. Total Mean Score: 39 items scored on 1-5 scale Physical Sub-Domain Mean Score: 16 items scored on 1-5 scale Communication Sub-Domain Mean Score: 7 items scored on a 1-5 scale Psychosocial Sub-Domain Mean Score: 16 items scored on 1-5 scale For the total score and each subdomain score, values are determined by adding the sum of items relevant to that score (all 39 items for the total mean score, 16 items for the Physical Sub-Domain Mean Score, 7 items for the Communication Sub-Domain Mean Score, 16 items for the Psychosocial Sub-Domain Mean Score), then dividing by the number of relevant items for that score. In each case, the resulting maximum score of 5 and a minimum score of 1, with higher scores indicating higher quality of life.
Mean Scores on the Acceptance and Action Questionnaire II	Baseline and Post-Treatment (within one week of completing the treatment phase)	The Acceptance and Action Questionnaire II (ACQ-II) is a self-report measure of psychological flexibility, acceptance, and experiential avoidance. It has 7 items rated on a 7-point scale (summed scores range from 7 to 49). Higher total scores reflect less psychological flexibility, while lower total scores reflect more flexibility. The ACQ-II will evaluate changes in psychological flexibility, the hypothesized mechanism of action underlying ACT for aphasia.
Mean Scores on the Communication Participation Item Bank	Baseline and Post-Treatment (within one week of completing the treatment phase)	The Communication Participation Item Bank (CPIB) is a patient-reported measure of communication participation defined as taking part in life situations where knowledge, information, ideas or feelings are exchanged. It has been validated for use with community-dwelling adults with multiple different communication disorders, including aphasia. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication participation.
Mean Scores on Modified University of Washington Resilience Scale	Baseline and Post-Treatment (within one week of completing the treatment phase)	The UWRS is a patient-reported outcome measure intended to measure an individual's perceived resilience. The original UWRS has been modified for people with aphasia (mUWRS), and was added to the study protocol for the second cohort of study participants to measure resilience pre- and post-treatment. This measure is reported as a T-score with a mean of 50 and a standard deviation (SD) of 10. A higher T-score represents a higher level of resilience.
Mean Scores on the Aphasia Outcome Measure	Baseline and Post-Treatment (within one week of completing the treatment phase)	The Aphasia Communication Outcome Measure (ACOM) is a measure of patient-reported communication functioning, defined as the ability to effectively convey and receive personally relevant messages in natural environments. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication functioning.

Countries

United States

Participant flow

Pre-assignment details

This study utilized a Stakeholder Advisory Board (SAB) of people with aphasia and care partners to provide input on treatment development. Members of the SAB were not study participants, and therefore were not enrolled as participants.

Participants by arm

Arm	Count
Acceptance and Commitment Therapy Adapted for Aphasia There is only a single study arm, in which the adapted intervention will be developed using a successive cohort design. Acceptance and Commitment Therapy for aphasia: The intervention will consist of Acceptance and Commitment Therapy modified to meet the needs of stroke survivors with aphasia, combined with communication strategy training.	20
Total	20

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Acceptance and Commitment Therapy Adapted for Aphasia
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	10 Participants
Age, Categorical Between 18 and 65 years	10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	18 Participants
Region of Enrollment United States	20 participants
Sex: Female, Male Female	9 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 20
other Total, other adverse events	0 / 20
serious Total, serious adverse events	0 / 20

Outcome results

Primary

Mean Scores on the Client Satisfaction Questionnaire - 8

The Client Satisfaction Questionnaire - 8 (CSQ-8) is a brief questionnaire demonstrated to provide efficient, sensitive, and reasonably comprehensive measures of patient satisfaction. It has 8 questions rated on a 4-point scale (summed scores range from 8 to 32). High scores indicate high satisfaction and low scores indicate low satisfaction. The CSQ-8 is the primary measure which will determine acceptability of the proposed pilot intervention.

Time frame: Post-treatment (within one week of completing the treatment phase)

Population: Data from 17 of the 19 completed participants were included in this analysis. This is due to missing data from the remaining 2 participants.

Arm	Measure	Value (MEAN)	Dispersion
Acceptance and Commitment Therapy Adapted for Aphasia	Mean Scores on the Client Satisfaction Questionnaire - 8	29.7 score on a scale	Standard Deviation 5.3

Secondary

Mean Scores on Modified University of Washington Resilience Scale

The UWRS is a patient-reported outcome measure intended to measure an individual's perceived resilience. The original UWRS has been modified for people with aphasia (mUWRS), and was added to the study protocol for the second cohort of study participants to measure resilience pre- and post-treatment. This measure is reported as a T-score with a mean of 50 and a standard deviation (SD) of 10. A higher T-score represents a higher level of resilience.