A Health & Wellness Intervention for Individuals With Traumatic Brain Injury (TBI)

Completed

Conditions studied: Traumatic Brain Injury

In brief

The primary goal of the proposed study is to evaluate the efficacy of a replicable community-based group intervention, designed to address both general wellness and specific TBI health-related issues. Emphasis is placed on goal setting to develop healthy habits, utilizing problem solving strategies, learning means of maintaining progress and setting new goals. Facilitators will utilize approaches aimed at maximizing participant self-efficacy, reducing barriers to health promotion, and developing personal resources. A randomized wait-list control group design will be used to evaluate the efficacy of the intervention. It is hypothesized that individuals with TBI who participate in the intervention group will report increased health promoting behaviors, health related self-efficacy, health-related quality of life, level of participation, and greater perceived wellness and satisfaction with life as compared to the control group.

Key facts

Study ID

NCT01334398

Run by

VA Eastern Colorado Health Care System

People needed

74

Starts

2008-10-01

Expected to finish

2014-11-01

Last updated by the study team

2014-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• individuals will be included in the study if they meet the following criteria:
• history of TBI as defined as damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
• received inpatient or outpatient rehabilitation, or an evaluation related to their TBI;
• are classified as moderate to severe TBI based on a TBI medical/professional evaluation;
• are at least one year post-injury;
• are 18 years of age or older at the time of the study;
• function at Rancho Los Amigo Level of Cognitive Functioning Level of 6 or above, based on current interview with participant and family member/identified resource person
• have adequate receptive and expressive communication skills functional for group participation (score >5 on the Comprehension and Expression items of the Functional Independence Measure (FIM) based on current interview);
• have sufficient recall of day-to-day events for learning in the group setting, based on screening interview with family member or identified resource person;
• have the ability to participate in ongoing group sessions with no documented or reported medical or neurological conditions (e.g. upcoming hospitalizations, uncontrolled seizures), behavioral concerns (e.g. frustration tolerance, behavioral/anger control,) or other issues that preclude group participation;
• be English speaking in order to complete study measures (if the intervention is proven efficacious, future studies would be needed with non-English speaking participants);
• provide informed consent to participate.

You may not qualify if…

• Failure to meet inclusion criteria
• Failure to provide informed consent as evidenced by inability to respond to the above stated questions

Where it is running

• VA ECHCS — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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