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

Taipei Medical University

Status: Active, not recruiting

Conditions: Stroke; Cognitive Impairment; Acquired Brain Injury

Treatments: Behavioral: Strategy Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04033952

N201905030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 2 patient groups

Assigned Interventions

Experimental group

Description:

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.

Treatment:

Behavioral: Strategy Training

Reflective listening

No Intervention group

Description:

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.