Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?
Primary Purpose
Brain Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Group Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries focused on measuring Cognitive Rehabilitation
Eligibility Criteria
Inclusion Criteria: All participants involved in the Cognitive Rehabilitation Outpatient Group within the study time frame are eligible to be in the study.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
provide evidence which supports cognitive therapy in a group setting
less labor intensive
cost effectiveness
peer feedback is effective
Secondary Outcome Measures
Full Information
NCT ID
NCT00166348
First Posted
September 12, 2005
Last Updated
January 19, 2010
Sponsor
Mayo Clinic
Collaborators
Nicloe Holzworth, OTR/L, Bergequist, Thomas, Ph.D., Brown, Allen, M.D., Sue Lepore, OTR/L, Walter Stobaugh. LICSW
1. Study Identification
Unique Protocol Identification Number
NCT00166348
Brief Title
Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?
Official Title
Efficacy of Group Based Cognitive Rehabilitation Following Acquired Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Nicloe Holzworth, OTR/L, Bergequist, Thomas, Ph.D., Brown, Allen, M.D., Sue Lepore, OTR/L, Walter Stobaugh. LICSW
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether there is benefit from providing cognitive rehabilitation in the group setting. Several standardized tools will be used to measure progress when a participant enters the group, leaves the group and at a one year follow-up.
Detailed Description
This research study will look at the outcome benefits of providing cognitive rehabilitation, utilizing the group process. Criteria for selecting the appropriate participants, group format and structure, as well as use of standardized assessments. The assessments used: Three Step Calendar Approach, (Sohlberg and Mateer) Satisfaction With Life scale (SWLS), Community Integration Questionnaire (CIQ), Independent Living Scale, and the Vocational Independence Scale. The group setting provides an atmosphere to work on building communication skills through peer feedback and to develop psychological coping strategies. Techniques such as the problem solving format and a calendar system. Analysis and outcomes of 17 past group participants were analyzed supporting cognitive rehabilitation in the group setting.
Of the 20 participants, 3 chose not to be included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
Cognitive Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Group Therapy
Primary Outcome Measure Information:
Title
provide evidence which supports cognitive therapy in a group setting
Title
less labor intensive
Title
cost effectiveness
Title
peer feedback is effective
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All participants involved in the Cognitive Rehabilitation Outpatient Group within the study time frame are eligible to be in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merri L Vitse
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Cognitive Rehabilitation Demonstrate Benefits in the Group Setting With People Whom Have Experienced Brain Injury?
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