Clinical trial NCT04984239: Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia
Official title: Adapting Acceptance and Mindfulness-based Behavior Therapy for Stroke Survivors With Aphasia to Improve Communication Success, Post-stroke Adaptation, and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Keywords: Counseling
Therapeutics
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Delaware
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Scores on the Client Satisfaction Questionnaire - 8
timeFrame: Post-treatment (within one week of completing the treatment phase)
Secondary outcomes:
measure: Mean Scores on the Acceptance and Action Questionnaire II
timeFrame: Baseline and Post-Treatment (within one week of completing the treatment phase)
measure: Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury
timeFrame: Baseline and Post-Treatment (within one week of completing the treatment phase)
measure: Mean Scores on the Kessler K6 Non-specific Distress Scale
timeFrame: Baseline and Post-Treatment (within one week of completing the treatment phase)
measure: Mean Scores on the Stroke and Aphasia Quality of Life Scale
timeFrame: Baseline and Post-Treatment (within one week of completing the treatment phase)
measure: Mean Scores on the Aphasia Outcome Measure
timeFrame: Baseline and Post-Treatment (within one week of completing the treatment phase)
measure: Mean Scores on the Communication Participation Item Bank
timeFrame: Baseline and Post-Treatment (within one week of completing the treatment phase)
measure: Mean Scores on Modified University of Washington Resilience Scale
timeFrame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: William Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References: