- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957358
Resolving Grief After Spinal Cord Injury
April 16, 2019 updated by: Dr. Karen Ethans
Resolving Grief and Moving On After Spinal Cord Injury
The purpose of this study is to examine the usefulness of the Grief Recovery Method in assisting persons with spinal cord injuries to achieve as complete a recovery as possible, thereby allowing for fuller participation in life.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M4
- Recruiting
- WRHA Health Sciences Centre Rehabilitation Hospital
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Principal Investigator:
- Karen Ethans, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
* Persons with a spinal cord injury who are willing to participate in the program.
Exclusion Criteria:
* Unable or unwilling to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle counselling using the Grief Recovery Method
Volunteers will participate in a series of weekly and twice-weekly sessions with a counselor who has obtained special training in the Grief Recovery Method.
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The Grief Recovery Method is a structured process designed to help people with spinal cord injuries examine their knowledge of their injury, their emotional reaction to their injury, and their ability to acknowledge their grief over the injury in order to learn techniques to resolve the grief in order to achieve a more complete recovery.
Participants will attend a total of 18 sessions, some one-on-one, and some in a group setting.
The Grief Recovery Handbook, handouts, DVD (digital video disc) presentations and questionnaires will be used.
Targeted activities to decrease isolation and assist volunteers to identify goals for recovery will be utilized.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Event Scale
Time Frame: At Sessions 1 and 18. (Baseline and month 4)
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A self-administered questionnaire with 22 questions designed to measure the subjective response to a specific traumatic event (for this study, the event is the spinal cord injury).
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At Sessions 1 and 18. (Baseline and month 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Grief Inventory
Time Frame: At Sessions 1and 18 (baseline and month 4).
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A self-reported 2-part questionnaire that asks the volunteer to circle responses to questions about past behavior and present feelings about their spinal cord injury.
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At Sessions 1and 18 (baseline and month 4).
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The Coping with Health Injuries and Problems
Time Frame: At sessions 1 and 18 (Baseline and month 4)
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A 32-question self-reported scale that measures coping with illness.
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At sessions 1 and 18 (Baseline and month 4)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
September 26, 2013
First Submitted That Met QC Criteria
September 30, 2013
First Posted (Estimate)
October 8, 2013
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
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Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
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University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
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Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
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NervGen PharmaRecruitingSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
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MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
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Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
-
The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
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StemCells, Inc.TerminatedStudy of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord InjuryCervical Spinal Cord Injury | Spine Injury | Cervical Spine InjuryUnited States, Canada
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S.Biomedics Co., Ltd.Yonsei University; Linical Co., Ltd.RecruitingSpinal Cord Injury, Acute | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C4 Level With Complete LesionKorea, Republic of
-
Kessler FoundationNew Jersey Commission on Spinal Cord ResearchRecruitingSpinal Cord Injuries | Incomplete Spinal Cord InjuryUnited States
Clinical Trials on The Grief Recovery Method
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Carlos III Health InstituteHealth Department of the Basque GovernmentCompleted
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Nanfang Hospital of Southern Medical UniversityCompleted
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Istanbul University - Cerrahpasa (IUC)CompletedMultisensory StimulationTurkey
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Universidad Nacional de ColombiaCompleted
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National Cheng-Kung University HospitalCompleted
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Yonsei UniversityCompletedNurses Who Have Experienced TraumaKorea, Republic of
-
Hasan Kalyoncu UniversityNot yet recruitingAsthma | Patient EducationTurkey
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Alberta Children's HospitalCompletedClubfoot | Ponseti Method | Talipes Equinovarus | CastingCanada
-
Istituto Ortopedico RizzoliRecruitingMetastasis Lung | Bone NeoplasmItaly
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Meshalkin Research Institute of Pathology of CirculationRecruitingCoronary Artery Disease | Surgery | Graft Failure | Coronary Artery Stenosis | Cardiac IschemiaRussian Federation