Trial Outcomes & Findings for Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia (NCT NCT04984239)
NCT ID: NCT04984239
Last Updated: 2025-04-25
Results Overview
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.
COMPLETED
NA
20 participants
Post-treatment (within one week of completing the treatment phase)
2025-04-25
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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20
|
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Overall Study
Cohort 1
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5
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Overall Study
Cohort 2
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15
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=20 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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20 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=17 Participants
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.
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|---|---|
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Mean Scores on the Client Satisfaction Questionnaire - 8
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29.7 score on a scale
Standard Deviation 5.3
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=19 Participants
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.
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|---|---|
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Mean Scores on the Acceptance and Action Questionnaire II
Pre-Treatment
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20.6315789 score on a scale
Standard Deviation 9.52313281
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Mean Scores on the Acceptance and Action Questionnaire II
Post-Treatment
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15.4210526 score on a scale
Standard Deviation 8.94002106
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=19 Participants
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.
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|---|---|
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Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury
Pre-Treatment
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49 score on a scale
Standard Deviation 8.0346472
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Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury
Post-Treatment
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45.9473684 score on a scale
Standard Deviation 9.52466788
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=19 Participants
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.
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|---|---|
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Mean Scores on the Kessler K6 Non-specific Distress Scale
Pre-Treatment
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7.26315789 score on a scale
Standard Deviation 4.025503492
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Mean Scores on the Kessler K6 Non-specific Distress Scale
Post-Treatment
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3.84210526 score on a scale
Standard Deviation 3.775110858
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=19 Participants
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.
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|---|---|
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Pre-Treatment Total Mean Score
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3.747789 score on a scale
Standard Deviation 0.56973
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Post-Treatment Total Mean Score
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4.039421 score on a scale
Standard Deviation 0.617423
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Pre-Treatment Physical sub-domain Mean Score
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4.135211 score on a scale
Standard Deviation 0.696638
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Post-Treatment Physical sub-domain Mean Score
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4.148211 score on a scale
Standard Deviation 0.88102
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Pre-Treatment Communication sub-domain Mean Score
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3.270842 score on a scale
Standard Deviation 0.800904
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Post-Treatment Communication sub-domain Mean Score
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3.744368 score on a scale
Standard Deviation 0.777438
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Pre-Treatment Psychosocial sub-domain Mean Score
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3.562737 score on a scale
Standard Deviation 0.852164
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Mean Scores on the Stroke and Aphasia Quality of Life Scale
Post-Treatment Psychosocial sub-domain Mean Score
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4.059368 score on a scale
Standard Deviation 0.683571
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=19 Participants
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.
|
|---|---|
|
Mean Scores on the Aphasia Outcome Measure
Pre-Treatment
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55.355625 T-score
Standard Deviation 8.20934506
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Mean Scores on the Aphasia Outcome Measure
Post-Treatment
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55.766875 T-score
Standard Deviation 9.94600806
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=19 Participants
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.
|
|---|---|
|
Mean Scores on the Communication Participation Item Bank
Pre-Treatment
|
45.3052632 T-score
Standard Deviation 6.78392493
|
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Mean Scores on the Communication Participation Item Bank
Post-Treatment
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47.4105263 T-score
Standard Deviation 6.06464204
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SECONDARY outcome
Timeframe: Baseline and Post-Treatment (within one week of completing the treatment phase)Population: This outcome measure was used in the second participant cohort only - data from all 14 participants in the second cohort were analyzed.
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.
Outcome measures
| Measure |
Acceptance and Commitment Therapy Adapted for Aphasia
n=14 Participants
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.
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|---|---|
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Mean Scores on Modified University of Washington Resilience Scale
Pre-Treatment
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48.87143 T-score
Standard Deviation 11.35439
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Mean Scores on Modified University of Washington Resilience Scale
Post-Treatment
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54.10714 T-score
Standard Deviation 10.149
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Adverse Events
Acceptance and Commitment Therapy Adapted for Aphasia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place