NCT01728350

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

4.7 years

First QC Date

November 9, 2012

Last Update Submit

January 26, 2018

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injuryvolunteeringwell beingcortisol

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.

    A five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.

    Baseline, post-intervention, 3 mos f/u, 6 mos f/u

Secondary Outcomes (4)

  • Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.

    Baseline, post-intervetion, 3mos f/u, 6mos f/u

  • Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.

    Baseline, post-intervention, 3mos f/u, 6mos f/u

  • Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.

    Baseline, post-intervention, 3mos f/u, 6mos f/u

  • Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.

    Baseline, post-intervention, 3mos f/u, 6mos f/u

Other Outcomes (1)

  • Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.

    Baseline, post-intervention, 3mos f/u, 6 mos f/u

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Behavioral: HOPE - Helping Others through Purpose and Engagement

Control

NO INTERVENTION

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

Interventions

HOPE - Helping Others through Purpose and EngagementBEHAVIORAL
Also known as: HOPE - Helping Other through Purpose and Engagement
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Lenore Hawley, LCSW

    Craig Hospital

    PRINCIPAL INVESTIGATOR

  • Lisa Payne, PhD

    Craig Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 19, 2012

Study Start

April 1, 2013

Primary Completion

December 27, 2017

Study Completion

December 27, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

US(1)