Spinal Cord InjuryNCT01957358
Resolving Grief After Spinal Cord Injury
A study testing The Grief Recovery Method in people with Spinal Cord Injury, run by Dr. Karen Ethans at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- The Grief Recovery Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons with a spinal cord injury who are willing to participate in the program.
Who cannot join
- Unable or unwilling to participate.
Trial locations and contacts
1 site in 1 country.
Gail Burnside contact
Canada1 site, 1 recruiting
- Recruiting
WRHA Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, R3A 1M4
Karen Ethans, MD
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury
- Being tested
- The Grief Recovery Method
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Grief Recovery MethodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counselling using the Grief Recovery Method | Experimental | 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. Receives: Behavioral: The Grief Recovery Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Event Scale
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).
Measured: At Sessions 1 and 18. (Baseline and month 4)
Secondary outcomes (2)
Modified Grief Inventory
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.
Measured: At Sessions 1and 18 (baseline and month 4).
The Coping with Health Injuries and Problems
A 32-question self-reported scale that measures coping with illness.
Measured: At sessions 1 and 18 (Baseline and month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Karen Ethans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Karen Ethans, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957358
- Sponsor's protocol ID
- GR2013
- Status last verified
- Apr 2019
- First submitted
- 26 Sep 2013
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolving Grief and Moving On After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01957358
- Acronym / sponsor ID
- GR2013
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Dr. Karen EthansUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 8 Oct 2013 (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 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counselling using the Grief Recovery Method | Experimental | Behavioral: The Grief Recovery MethodVolunteers will participate in a series of weekly and twice-weekly sessions with a counselor who has obtained special training in the Grief Recovery Method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with a spinal cord injury who are willing to participate in the program.
Key exclusion criteria (1 listed)
- Unable or unwilling to participate.
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 |
|---|---|---|
| The Grief Recovery MethodThe 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. | Behavioural | Lifestyle counselling using the Grief Recovery Method |
Primary outcome
Impact of Event Scale
Time frame: At Sessions 1 and 18. (Baseline and month 4)
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).
2 secondary outcomes
Modified Grief Inventory
Time frame: At Sessions 1and 18 (baseline and month 4).
The Coping with Health Injuries and Problems
Time frame: At sessions 1 and 18 (Baseline and month 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
Gail Burnside contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Grief Recovery Method in people with Spinal Cord Injury, run by Dr. Karen Ethans at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Apr 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gail Burnside ((204) 786-4753), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Event Scale (time frame: At Sessions 1 and 18. (Baseline and month 4)). 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 18 Apr 2019.