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

NCT ID: NCT04033952

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-29
• Study Completion Date: 2024-09-30

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.

Conditions

Cognitive Impairment; Stroke; Acquired Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Strategy Training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Strategy Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng-Hang Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng-Hang Chang

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

National Taiwan University Hospital Bei-Hu branch

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N201905030

Identifier Type: -

Identifier Source: org_study_id