Strategy Training on Improving Executive Functions in Persons Following Acquired Brain Injury

NCT04033952 | Active Not Recruiting

• 1 other identifier: N201905030
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Cognitive Impairment; Stroke; Acquired Brain Injury

Keywords

Stroke; Cognition; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Stroop Test

  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.

  Change from baseline to post-intervention within 1 week

• Trail-Making Test (TMT A and B)

  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.

  Change from baseline to post-intervention within 1 week

• Montreal Cognitive Assessment (MoCA)

  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.

  Change from baseline to post-intervention within 1 week

Secondary Outcomes (59)

• 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

• Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms

  Change from 6 month to 12 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

Study Arms (2)

Assigned Interventions

EXPERIMENTAL

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.

Behavioral: Strategy Training

Reflective listening

NO INTERVENTION

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.

Interventions

Strategy Training BEHAVIORAL

This approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life.

Assigned Interventions

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 20 years and older
• Has a diagnosis of Acquired Brain Injury
• Understand Mandarin
• Has cognitive impairment
• Provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (3)

National Taiwan University Hospital Bei-Hu branch

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Medical University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Feng-Hang Chang

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: May 29, 2018
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)