Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 7:25 PM
Study NCT ID:
NCT01728350
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2012-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Well-Being After TBI Through Structured Volunteer Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-14', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline on Hair Cortisol test at post-intervention and at follow-up points.', 'timeFrame': 'Baseline, post-intervention, 3mos f/u, 6 mos f/u', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.', 'timeFrame': 'Baseline, post-intervention, 3 mos f/u, 6 mos f/u', 'description': 'A five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.', 'timeFrame': 'Baseline, post-intervetion, 3mos f/u, 6mos f/u', 'description': '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.'}, {'measure': 'Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.', 'timeFrame': 'Baseline, post-intervention, 3mos f/u, 6mos f/u', 'description': 'An 18-item, self-rated measure of psychological distress. Items are rated on 0-4 Likert scale.'}, {'measure': 'Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.', 'timeFrame': 'Baseline, post-intervention, 3mos f/u, 6mos f/u', 'description': '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.'}, {'measure': 'Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.', 'timeFrame': 'Baseline, post-intervention, 3mos f/u, 6mos f/u', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['traumatic brain injury', 'volunteering', 'well being', 'cortisol'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has sustained a documented TBI that required inpatient rehabilitation;\n* is at least one year post TBI;\n* is age 18 or older;\n* is able to commit to completing the entire three month volunteer placement;\n* is English or Spanish speaking;\n* receives written medical release from a physician to participate in this intervention;\n* is rated a level 1-2 on the Supervision Rating Scale (functionally independent during the day);\n* provides informed consent to participate\n\nExclusion Criteria:\n\n* Is employed or engaged in regularly scheduled volunteer work outside of the intervention;\n* obtains a score of 25 or above on the SWLS, which is 0.5 SD above the TBIMS NDB mean;\n* unable to travel to assessments and placement; even with study transportation assistance;\n* has been convicted of a felony, which would prohibit volunteer placement;\n* unable to communicate effectively to complete standardized assessments;\n* has cognitive impairment that precludes completion of baseline testing;'}, 'identificationModule': {'nctId': 'NCT01728350', 'briefTitle': 'Improving Well-Being After TBI Through Structured Volunteer Activity', 'organization': {'class': 'OTHER', 'fullName': 'Craig Hospital'}, 'officialTitle': 'Improving Well-Being After TBI Through Structured Volunteer Activity', 'orgStudyIdInfo': {'id': 'H133A120032-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '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.', 'interventionNames': ['Behavioral: HOPE - Helping Others through Purpose and Engagement']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study.'}], 'interventions': [{'name': 'HOPE - Helping Others through Purpose and Engagement', 'type': 'BEHAVIORAL', 'otherNames': ['HOPE - Helping Other through Purpose and Engagement'], 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Craig Hospital', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}], 'overallOfficials': [{'name': 'Lenore Hawley, LCSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Craig Hospital'}, {'name': 'Lisa Payne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Craig Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Craig Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}