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Completed

NCT Number: NCT01728350

Improving Well-Being After TBI Through Structured Volunteer Activity

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

HOPE - Helping Others through Purpose and Engagement

Behavioral

Other names: HOPE - Helping Other through Purpose and Engagement

Primary outcomes

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

    Time frame: Baseline, post-intervention, 3 mos f/u, 6 mos f/u

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

Secondary outcomes

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

    Time frame: Baseline, post-intervetion, 3mos f/u, 6mos f/u

    An 8-item self-rated scale of perceived success in areas such as social relationships, self-esteem, and purpose in life. Items are rated on 1-7 point Likert scale.

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

    Time frame: Baseline, post-intervention, 3mos f/u, 6mos f/u

    An 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale.

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

    Time frame: Baseline, post-intervention, 3mos f/u, 6mos f/u

    A 12-item, self-rated scale that evaluates positive and negative emotions. It produces a score of positive and negative feelings that can be combined to create a balance score.

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

    Time frame: Baseline, post-intervention, 3mos f/u, 6mos f/u

    Consists of nine, self-rated items regarding individual goals, sense of direction, and meaning. This subscale was selected because volunteering has been shown to have a positive relationship with a sense of purpose in life.

Other outcomes

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

    Time frame: Baseline, post-intervention, 3mos f/u, 6 mos f/u

    This is considered an Exploratory Measure. Cortisol has been explored as a potential biomarker of well-being; lower levels of salivary cortisol have been associated with higher levels of psychological well-being. Recently, reliable and valid methods for measuring long-term cortisol secretion through hair samples have been developed and are being used as biomarkers of chronic stress in multiple medical conditions.

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 19, 2012
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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