Outcomes Following Neuropsychological Intervention in Acquired Brain Injury Outpatients With Executive Dysfunction

NCT01992055 | Completed

• 1 other identifier: H2013:389
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This Clinical Trial is a pilot study being conducted to study the impact of a specific cognitive rehabilitation program, Goal Management Training (GMT), in adult patients with executive dysfunction and associated problems in everyday functioning. The intervention program will also include relaxation training and psychoeducation regarding brain injury on everyday functioning, emotional status, and executive functioning. Goal Management Training focuses on teaching individuals strategies to compensate for executive functioning deficits and is based on a theory of goal neglect resulting in disorganized behavior following frontal lobe injury. It emphasizes strategies for self-monitoring and self-evaluation in everyday life. Given its goal-oriented emphasis, focus on individual everyday difficulties, and reports of improvements in self-reported executive failures and mood, GMT appears to be an ideal intervention treatment for individuals with executive and functional deficits. Given the emphasis of goal-oriented rehabilitation on reducing the impact of cognitive impairment on daily functioning, rather than attempting to restore cognitive abilities, a reduction in subjective reports of psychological distress is anticipated. This hypothesis is consistent with existing literature revealing reduced reports of annoyance and executive difficulties on self-report inventories. Improvements on tests of sustained attention and visuospatial problem-solving, as well as small effects on additional measures of planning, are also anticipated.

Conditions

Acquired Brain Injury

Keywords

Executive dysfunction; Neuropsychological rehabilitation; Goal Management Training

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in neuropsychological functioning at 1 week post-intervention

  Change in test scores on the following measures: Connor's Continuous Performance Test - II Delis-Kaplan Executive Functioning Scale Tower Test Trail Making Test Ruff Figural Fluency Test Controlled Oral Word Association Test Semantic Fluency Golden's Stroop Color and Word Test BADS Six Elements Test Brief-A Self and Family Report Inventories SCL-90-R Self-Report Inventory Word Memory Test Medical Symptom Validity Test (MSVT) Non-Verbal MSVT

  1 week post-intervention

Secondary Outcomes (1)

• Change from Baseline in neuropsychological functioning at 4 weeks post-intervention

  4 weeks post-intervention

Other Outcomes (1)

• Change from Baseline in neuropsychological functioning at 1 year post-intervention

  1 year post intervention

Study Arms (2)

Goal Management Training

EXPERIMENTAL

The modified GMT intervention will consist of seven group sessions and, similar to van Hooren et al (2007), an individual session with a neuropsychologist on Session 5. Sessions will be held twice weekly. The manualized group sessions will include: (1) structured psychoeducation introducing participants to the brain and executive functioning, the relationship between stress and cognitive functioning, and relaxation training; (2) stepwise learning of GMT, including education regarding attentional lapses and goal neglect, as well as in-session practice targeting individual everyday functional deficits with the goal of maximizing generalization. Homework assignments targeting individual functional deficits will be assigned following each session.

Behavioral: Goal Management Training

Education & relaxation training

ACTIVE COMPARATOR

Education and relaxation training control group

Behavioral: Education & relaxation training

Interventions

Goal Management Training BEHAVIORAL

Participants will be randomly assigned to the GMT Treatment. The GMT cognitive rehabilitation intervention program will be administered in group format, consisting of 8 sessions, including structured psychoeducation, relaxation training, and stepwise learning of GMT.

Goal Management Training

Education & relaxation training BEHAVIORAL

The Education \& Relaxation Training Control Group program will also be administered in group format, consisting of two sessions, including structured psychoeducation and relaxation training. Participants assigned to the Control condition will be offered the opportunity to complete the full GMT program following the completion of the study.

Education & relaxation training

Eligibility Criteria

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

You may qualify if:

• Participants may be included in the study if they are identified as having EF impairments, secondary to an acquired brain injury, and are between the ages of 18 and 65 years. Informed consent will be gathered from each participant. Eligible participants will be informed about the purpose of the study, the associated risks and benefits, and their option to withdraw from the study at any time without penalty. Potential risks include subtle discomfort when initially participating in relaxation exercises, which typically resolves with familiarity, and mild distress during neuropsychological assessment. These issues sometimes arise during standard clinical practice and the neuropsychologists involved are experienced in assisting people in reducing their distress.

You may not qualify if:

• Individuals with significant memory impairment, receptive language deficits, active psychosis, severe depression (i.e., Beck Depression Inventory - II \[BDI-II\] ≥ 30), or a diagnosis of dementia will be excluded from participating in the study.. A minimum of 36 participants will be recruited for this study.

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre Foundation, Manitoba: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 3N4, Canada

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Educational Status; Relaxation Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lesley Ritchie, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

CA (1)