N/A
N=20
Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia
Stroke · Aphasia
Bottom Line
View on ClinicalTrials.gov: NCT04984239 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Mean Scores on the Client Satisfaction Questionnaire - 8 — 29.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acceptance and Commitment Therapy for aphasia (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Scores on the Client Satisfaction Questionnaire - 8 |
29.7 | — |
| SECONDARY Mean Scores on the Acceptance and Action Questionnaire II |
20.6315789; 15.4210526 | — |
| SECONDARY Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury |
49; 45.9473684 | — |
| SECONDARY Mean Scores on the Kessler K6 Non-specific Distress Scale |
7.26315789; 3.84210526 | — |
| SECONDARY Mean Scores on the Stroke and Aphasia Quality of Life Scale |
3.747789; 4.039421; 4.135211; 4.148211; 3.270842; 3.744368 | — |
| SECONDARY Mean Scores on the Aphasia Outcome Measure |
55.355625; 55.766875 | — |
| SECONDARY Mean Scores on the Communication Participation Item Bank |
45.3052632; 47.4105263 | — |
| SECONDARY Mean Scores on Modified University of Washington Resilience Scale |
48.87143; 54.10714 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04984239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.