Improving Well-Being After TBI Through Structured Volunteer Activity

NCT ID: NCT01728350

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-12-27

Brief Summary

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The purpose of this project is to determine if participating in volunteer activity improves the psychological well-being of individuals with traumatic brain injury (TBI).

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Participants in this arm will participate in a novel structured volunteering intervention called HOPE - Helping Others through Purpose and Engagement. This intervention involves orientation, training, volunteer placement assistance, and problem solving and support.

Group Type EXPERIMENTAL

HOPE - Helping Others through Purpose and Engagement

Intervention Type BEHAVIORAL

Control

Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HOPE - Helping Others through Purpose and Engagement

Intervention Type BEHAVIORAL

Other Intervention Names

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HOPE - Helping Other through Purpose and Engagement

Eligibility Criteria

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Inclusion Criteria

* Has sustained a documented TBI that required inpatient rehabilitation;
* is at least one year post TBI;
* is age 18 or older;
* is able to commit to completing the entire three month volunteer placement;
* is English or Spanish speaking;
* receives written medical release from a physician to participate in this intervention;
* is rated a level 1-2 on the Supervision Rating Scale (functionally independent during the day);
* provides informed consent to participate

Exclusion Criteria

* Is employed or engaged in regularly scheduled volunteer work outside of the intervention;
* obtains a score of 25 or above on the SWLS, which is 0.5 SD above the TBIMS NDB mean;
* unable to travel to assessments and placement; even with study transportation assistance;
* has been convicted of a felony, which would prohibit volunteer placement;
* unable to communicate effectively to complete standardized assessments;
* has cognitive impairment that precludes completion of baseline testing;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Craig Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lenore Hawley, LCSW

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital

Lisa Payne, PhD

Role: PRINCIPAL_INVESTIGATOR

Craig Hospital

Locations

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Craig Hospital

Englewood, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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H133A120032-1

Identifier Type: -

Identifier Source: org_study_id

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