Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992055
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
Health Sciences Centre Foundation, Manitoba
Information provided by (Responsible Party):
Dr. Lesley Ritchie, University of Manitoba

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.


Condition or disease Intervention/treatment Phase
Acquired Brain Injury Behavioral: Goal Management Training Behavioral: Education & relaxation training Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Outcomes Following Neuropsychological Intervention in Acquired Brain Injury Outpatients With Executive Dysfunction
Study Start Date : December 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Goal Management Training
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
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.

Active Comparator: Education & relaxation training
Education and relaxation training control group
Behavioral: Education & relaxation training
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.




Primary Outcome Measures :
  1. Change from Baseline in neuropsychological functioning at 1 week post-intervention [ Time Frame: 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



Secondary Outcome Measures :
  1. Change from Baseline in neuropsychological functioning at 4 weeks post-intervention [ Time Frame: 4 weeks 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 Non-Verbal MSVT



Other Outcome Measures:
  1. Change from Baseline in neuropsychological functioning at 1 year post-intervention [ Time Frame: 1 year 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 Non-Verbal MSVT




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992055


Locations
Layout table for location information
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3N4
Sponsors and Collaborators
University of Manitoba
Health Sciences Centre Foundation, Manitoba
Investigators
Layout table for investigator information
Principal Investigator: Lesley Ritchie, Ph.D. University of Manitoba
Layout table for additonal information
Responsible Party: Dr. Lesley Ritchie, Assistant Professor/Neuropsychologist, University of Manitoba
ClinicalTrials.gov Identifier: NCT01992055    
Other Study ID Numbers: H2013:389
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Keywords provided by Dr. Lesley Ritchie, University of Manitoba:
Executive dysfunction
Neuropsychological rehabilitation
Goal Management Training
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System