18 and older, any sex, with Stroke or Aphasia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Scores on the Client Satisfaction Questionnaire - 8Primary· 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.
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
29.7
± 5.3
Mean Scores on the Acceptance and Action Questionnaire IISecondary· 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.
Pre-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
20.6315789
± 9.52313281
Post-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
15.4210526
± 8.94002106
Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain InjurySecondary· 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 h
Pre-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
49
± 8.0346472
Post-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
45.9473684
± 9.52466788
Mean Scores on the Kessler K6 Non-specific Distress ScaleSecondary· 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.
Pre-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
7.26315789
± 4.025503492
Post-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
3.84210526
± 3.775110858
Mean Scores on the Stroke and Aphasia Quality of Life ScaleSecondary· 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 it
Pre-Treatment Total Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
3.747789
± 0.56973
Post-Treatment Total Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
4.039421
± 0.617423
Pre-Treatment Physical sub-domain Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
4.135211
± 0.696638
Post-Treatment Physical sub-domain Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
4.148211
± 0.88102
Pre-Treatment Communication sub-domain Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
3.270842
± 0.800904
Post-Treatment Communication sub-domain Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
3.744368
± 0.777438
Pre-Treatment Psychosocial sub-domain Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
3.562737
± 0.852164
Post-Treatment Psychosocial sub-domain Mean Score
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
4.059368
± 0.683571
Mean Scores on the Aphasia Outcome MeasureSecondary· 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.
Pre-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
55.355625
± 8.20934506
Post-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
55.766875
± 9.94600806
Mean Scores on the Communication Participation Item BankSecondary· 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.
Pre-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
45.3052632
± 6.78392493
Post-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
47.4105263
± 6.06464204
Mean Scores on Modified University of Washington Resilience ScaleSecondary· 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.
Pre-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
48.87143
± 11.35439
Post-Treatment
Group
Value
95% CI
Acceptance and Commitment Therapy Adapted for Aphasia
54.10714
± 10.149
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
Last refreshed: 25 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04984239.