Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia

NCT04984239 | Completed Results

• 2 other identifiers: STUDY20090213R03HD104246-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Aphasia

Keywords

Counseling; Therapeutics

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (7)

• Mean Scores on the Acceptance and Action Questionnaire II

  Baseline and Post-Treatment (within one week of completing the treatment phase)

• Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury

  Baseline and Post-Treatment (within one week of completing the treatment phase)

• Mean Scores on the Kessler K6 Non-specific Distress Scale

  Baseline and Post-Treatment (within one week of completing the treatment phase)

• Mean Scores on the Stroke and Aphasia Quality of Life Scale

  Baseline and Post-Treatment (within one week of completing the treatment phase)

• Mean Scores on the Aphasia Outcome Measure

  Baseline and Post-Treatment (within one week of completing the treatment phase)

Study Arms (1)

Acceptance and Commitment Therapy adapted for aphasia

OTHER

There is only a single study arm, in which the adapted intervention will be developed using a successive cohort design.

Behavioral: Acceptance and Commitment Therapy for aphasia

Interventions

Acceptance and Commitment Therapy for aphasia BEHAVIORAL

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

Acceptance and Commitment Therapy adapted for aphasia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Delaware: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: William Evans
• Organization: University of Pittsburgh

will.evans@pitt.edu

412-383-6943

Study Officials

• William Evans, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 30, 2021
• Study Start: November 2, 2021
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be shared at the time of study publication without planned end to access.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)