Strategy Training on Improving Executive Functions in Persons Following Acquired Brain Injury
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Taipei Medical University
- Enrollment
- 180
- Locations
- 3
- Primary Endpoint
- Stroop Test
Study Overview
Brief Summary
About two-third individuals with acquired brain injury (ABI) experience cognitive impairments. Deficits in executive functions is one of the most prevalent cognitive impairments following ABI which result in decline of recovery and independence. Lack of intervention shows evidence of immediate and long-term effect on executive function which is critical after returning to the community. The overall aim of this study is to examine the efficacy of strategy training intervention on executive functions and participation on community-dwelling people with ABI. Findings of the study will provide unequivocal evidence on the duration of effectiveness of strategy training and support the development and application of the program in rehabilitation practice.
Detailed Description
The study will use a double-blinded, parallel-group randomized controlled trial to assess the efficacy of the strategy training intervention program in comparison to the control group. The investigators will recruit community-dwelling individuals with ABI in outpatient rehabilitation units and randomly assign them to the intervention group and the control group at a 1:1 ratio. Participants in the intervention group will receive strategy training 2 times per week for 10-15 sessions and participants in the control group will receive dose-matched non-active intervention carried out by a trained therapist. These efforts will allow the investigators to address the gap in rehabilitation research by demonstrating the effectiveness of strategy training on rebuilding and maintaining executive functions and lessening disability. This evidence will be important for rehabilitation practitioners to provide effective treatment to patients with cognitive impairments and will contribute to the improvement of quality of care of rehabilitation services.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 20 years and older
- •Has a diagnosis of Acquired Brain Injury
- •Understand Mandarin
- •Has cognitive impairment
- •Provide informed consent
Exclusion Criteria
- •Have severe aphasia
- •Have a pre-stroke diagnosis of dementia, current major depressive disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.
Arms & Interventions
Assigned Interventions
The OPASS program will be delivered to the intervention group. The intervention protocols of the OPASS program were developed based on the strategy training guidelines developed by Skidmore et al. and based on the findings identified from the feasibility study. Trained research therapists will take the responsibility for delivering the intervention to participants. The program consists of four critical ingredients: self-selected goals, self-evaluation of performance, strategy development, and implementation, and therapeutic guided discovery.
Intervention: Strategy Training (Behavioral)
Reflective listening
Participants in the control group will receive dose-matched non-active intervention carried out by a trained research staff. The staff will use scripted questions to provoke participants to describe their experiences and feelings about their disease and their usual-care rehabilitation activities.
Outcomes
Primary Outcomes
Stroop Test
Time Frame: Change from baseline to post-intervention within 1 week
Stroop test is a behavioral cognitive assessment tool. Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time and error to complete the task will be calculated and recorded, in which a longer completion time and more error will indicate poorer outcome. Construct validity of the Stroop Test in the TBI population has been published.
Montreal Cognitive Assessment (MoCA)
Time Frame: Change from baseline to post-intervention within 1 week
Montreal Cognitive Assessment (MoCA) is a clinician-reported measure consisting of cognition domains such as: visuospatial skills, executive functions, attention, concentration, calculation, language, abstraction, memory, and orientation. The summary score ranges from 0-30 points with higher scores indicating better cognitive function.
Trail-Making Test (TMT A and B)
Time Frame: Change from baseline to post-intervention within 1 week
Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time and the amount of needed reminders to complete TMT A and B will be calculated, in which a longer completion time and more error will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
Secondary Outcomes
- General Self Efficacy Scale (GSCS)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Qualitative data(After intervention, an average of 2 month)
- Montreal Cognitive Assessment (MoCA)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Level of understanding of the intervention session(During the procedure)
- Canadian Occupational Performance Measure (COPM)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Stroop Test(Change from 6 month to 12 month follow-up, within 2 weeks)
- National Institutes of Health Stroke scale (NIHSS)(Change from 6 month to 12 month follow-up, within 2 weeks)
- functional Magnetic Resonance Imaging scan with a Emotion Stroop task(Change from post-intervention to 1 year follow-up, within 2 weeks)
- Client Satisfaction Questionnaire (CSQ)(At the time of post-intervention within 1 week)
- Trail-Making Test (TMT A and B)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Rancho Los Amigos Scale-Revised (RLAS-R)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Euro-QoL-5-Dimension (EQ-5D)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Pittsburgh Rehabilitation Participation Scale(During the procedure)
- Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms(Change from 6 month to 12 month follow-up, within 2 weeks)
- Resting-state functional Magnetic Resonance Imaging scan (rs-fMRI)(Change from post-intervention to 1 year follow-up, within 2 weeks)
- Healing encounters and attitudes list treatment expectancy short form (HEAL-TE)(baseline, pre-intervention)
- Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Modified Rankin Scale (mRS)(Change from 6 month to 12 month follow-up, within 2 weeks)
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)(Change from 6 month to 12 month follow-up, within 2 weeks)
- functional Magnetic Resonance Imaging scan with a Color Stroop task(Change from post-intervention to 1 year follow-up, within 2 weeks)
- functional Magnetic Resonance Imaging scan of anatomical structure(Change from post-intervention to 1 year follow-up, within 2 weeks)
- Healing encounters and attitudes list patient-provider connection short form (HEAL-PPC)(At the time of post-intervention within 1 week)
- Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms(Change from baseline to post-intervention within 1 week)
- Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms(Change from 3 month to 6 month follow-up, within 2 weeks)
- Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)(Change from baseline to post-intervention within 1 week)
- Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Healing encounters and attitudes list positive outlook questionnaire short form (HEAL-PO)(Change from 3 month to 6 month follow-up, within 2 weeks)
- General Self Efficacy Scale (GSCS)(Change from baseline to post-intervention within 1 week)
- General Self Efficacy Scale (GSCS)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- General Self Efficacy Scale (GSCS)(Change from 3 month to 6 month follow-up, within 2 weeks)
- Canadian Occupational Performance Measure (COPM)(Change from baseline to post-intervention within 1 week)
- Canadian Occupational Performance Measure (COPM)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Canadian Occupational Performance Measure (COPM)(Change from 3 month to 6 month follow-up, within 2 weeks)
- Stroop Test(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Stroop Test(Change from 3 month to 6 month follow-up, within 2 weeks)
- Trail-Making Test (TMT A and B)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Trail-Making Test (TMT A and B)(Change from 3 month to 6 month follow-up, within 2 weeks)
- National Institutes of Health Stroke scale (NIHSS)(Change from baseline to post-intervention within 1 week)
- National Institutes of Health Stroke scale (NIHSS)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- National Institutes of Health Stroke scale (NIHSS)(Change from 3 month to 6 month follow-up, within 2 weeks)
- Rancho Los Amigos Scale-Revised (RLAS-R)(Change from baseline to post-intervention within 1 week)
- Rancho Los Amigos Scale-Revised (RLAS-R)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Rancho Los Amigos Scale-Revised (RLAS-R)(Change from 3 month to 6 month follow-up, within 2 weeks)
- Modified Rankin Scale (mRS)(Change from baseline to post-intervention within 1 week)
- Modified Rankin Scale (mRS)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Modified Rankin Scale (mRS)(Change from 3 month to 6 month follow-up, within 2 weeks)
- Euro-QoL-5-Dimension (EQ-5D)(Change from baseline to post-intervention within 1 week)
- Euro-QoL-5-Dimension (EQ-5D)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Euro-QoL-5-Dimension (EQ-5D)(Change from 3 month to 6 month follow-up, within 2 weeks)
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)(Change from baseline to post-intervention within 1 week)
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)(Change from 3 month to 6 month follow-up, within 2 weeks)
- Resting-state functional Magnetic Resonance Imaging scan (rs-fMRI)(Change from baseline to post-intervention within 1 week)
- functional Magnetic Resonance Imaging scan with a Color Stroop task(Change from baseline to immediately post-intervention within 1 week)
- functional Magnetic Resonance Imaging scan of anatomical structure(Change from baseline to post-intervention within 1 week)
- functional Magnetic Resonance Imaging scan with a Emotion Stroop task(Change from baseline to post-intervention within 1 week)
- Montreal Cognitive Assessment (MoCA)(Change from post-intervention to 3 month follow-up, within 2 weeks)
- Montreal Cognitive Assessment (MoCA)(Change from 3 month to 6 month follow-up, within 2 weeks)
Investigators
Feng-Hang Chang
Professor
Taipei Medical University