Traumatic Brain InjuryNCT01728350
Improving Well-Being After TBI Through Structured Volunteer Activity
A study testing HOPE - Helping Others through Purpose and Engagement in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- HOPE - Helping Others through Purpose and Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 27 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Traumatic Brain Injury
- Being tested
- HOPE - Helping Others through Purpose and Engagement
- Keywords
- traumatic brain injury, volunteering, well being, cortisol
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPE - Helping Others through Purpose and EngagementBehavioural
Also called HOPE - Helping Other through Purpose and Engagement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
An 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline, post-intervention, 3mos f/u, 6mos f/u
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startApr 2013
- Primary completion27 Dec 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lenore Hawley, LCSW, Principal investigator, Craig HospitalLisa Payne, PhD, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728350
- Sponsor's protocol ID
- H133A120032-1
- Status last verified
- Jan 2018
- First submitted
- 9 Nov 2012
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Well-Being After TBI Through Structured Volunteer Activity
- ClinicalTrials.gov ID
- NCT01728350
- Acronym / sponsor ID
- H133A120032-1
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, volunteering, well being, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 19 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: HOPE - Helping Others through Purpose and EngagementParticipants 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. |
| Control | No intervention | –Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOPE - Helping Others through Purpose and EngagementAlso: HOPE - Helping Other through Purpose and Engagement | Behavioural | Treatment |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenore Hawley, LCSW principal investigator
Craig Hospital
Lisa Payne, PhD principal investigator
Craig Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE - Helping Others through Purpose and Engagement in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.