NCT01957358

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

6.2 years

First QC Date

September 26, 2013

Last Update Submit

April 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    At Sessions 1 and 18. (Baseline and month 4)

Secondary Outcomes (2)

  • Modified Grief Inventory

    At Sessions 1and 18 (baseline and month 4).

  • The Coping with Health Injuries and Problems

    At sessions 1 and 18 (Baseline and month 4)

Study Arms (1)

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.

Behavioral: The Grief Recovery Method

Interventions

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.

Lifestyle counselling using the Grief Recovery Method

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \* Persons with a spinal cord injury who are willing to participate in the program.

You may not qualify if:

  • \* Unable or unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WRHA Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Gail Burnside

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Spinal Cord Injury Rehabilitation Program

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 8, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations