search
Back to results

A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma

Primary Purpose

Musculoskeletal Injury, Traumatic Injury

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Supportive Expressive Group Therapy
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Musculoskeletal Injury focused on measuring Group Therapy, Neuromusculoskeletal Traumatic Injury, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. English speaking adults aged 18 years and older.
  2. Admitted to SJR for inpatient rehabilitation.
  3. Trauma-related peripheral nerve injury, muscle injury, amputation, and/or fracture(s).
  4. Are medically stable.
  5. Have no clinical suspicion of cognitive impairment or unstable severe mental health diagnosis (e.g. moderate/severe brain injury, schizophrenia, dementia, etc.).

Exclusion Criteria:

  1. Are actively suicidal.
  2. Are unable participate effectively in a group setting (e.g. actively using substances, exhibiting threatening behaviors).

Sites / Locations

  • Sunnybrook Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supportive-expressive group therapy

Treatment as usual

Arm Description

The SEGT is a six-module program where each session is approximately one hour, and is held twice a week over a three-week period. It is framed within social cognitive theory, whereby resilience to adversity (NMSK trauma in this instance) relies on personal enablement. Enablement serves to equip the individual with the personal resources to cultivate their self-efficacy and mastery and to select and construct environments that promote successful adaption.

The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation).

Outcomes

Primary Outcome Measures

Participant recruitment
Number of participants who are recruited into the study and are contacted for assessments at set time intervals.
Questionnaire completion rates
Number of completed assessments
Treatment adherence
Number of participants who complete all 6 SEGT sessions
Number of participants contacted for follow up interview
Number of participants contacted for follow up interview
Participant retention
Number of participants who complete the 3 month post-discharge assessments
Participant Retention
Number of participants who complete 1 month post-discharge interview
Barriers and Facilitators to Group Participation
As discussed in qualitative interviews

Secondary Outcome Measures

Change in Health-related quality of life
Short Form-36 Survey (SF-36): The SF-36 is the most widely used generic health-related QoL tool. The tool measures 8 domains including physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, social functioning, general mental health, role limitations due to emotional problems, and vitality. The minimum score is 0, and the maximum is 100. Higher scores on the measure are indicative of less disability.
Change in coping self-efficacy
Coping Self-Efficacy Scale (CSES): The CSES is a measures perceived self-efficacy for coping with challenges and threats. It is a 26-item measure rated using an 11-point scale with the anchors 0 (cannot do at), 5 (moderately certain can do), and 10 (certain can do). Total scores (ranging from 0-260) are calculated by summing the item scores and a higher score indicates higher coping self-efficacy.
Change in impact of traumatic life event
Impact Event Scale Revised (IES-R): The IES44 is a 15-item scale that assesses the impact of a traumatic life event, and has two subscales assessing the frequency of intrusive and avoidant cognitions associated with a specific stressor. It uses a 4-point scale, not at all to often to assess how often a respondent experienced specific symptoms during the past week. The IES was revised 45 to assess the three cluster symptoms of PTSD: intrusions, avoidance, and hyperarousal. Scores range from 0-88, with higher scores indicating more severe impact.
Change in post-traumatic stress disorder
Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C): The PCL-C47 is a standardized 17-item self-report rating scale for PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point scale, with higher scores indicating more severe levels of PTSD, and it is a well-validated measure across different populations. Scores range from a minimum of 0, to a maximum of 80.
Change in post-traumatic growth
Post-Traumatic Growth Inventory (PTGI): The PTGI is a 21-item scale assessing positive outcomes reported by those who have experienced traumatic events.48 Items are scored on a 6-point scale and scores range from 0 to 105, with higher scores indicating greater levels of growth. It has good levels of internal consistency reliability (α=.90) and 2-month test-retest stability (r =.71).

Full Information

First Posted
April 1, 2022
Last Updated
July 6, 2023
Sponsor
Sunnybrook Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT05320445
Brief Title
A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma
Official Title
A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Traumatic physical injuries result in significant disability and a high proportion of survivors suffer from chronic pain and mental health disorders. A key predictor of good outcomes following trauma is "coping self-efficacy" - a person's belief that they can cope with life's challenges. Interventions that enhance coping self-efficacy post-injury are most likely to optimize recovery. However, these interventions are not standard approaches in rehabilitation settings.Our inter-disciplinary team will undertake a trial to assess the efficacy of supportive-expressive group therapy in rehabilitation inpatients who have had traumatic injuries. We wish to test whether persons who undergo the group therapy have significant improvements in coping self-efficacy compared to those receiving standard care. Sixty patients with traumatic injuries admitted to St. John's Rehab will be randomized to either supportive-expressive group therapy (n=30) or to standard rehabilitation (n=30). Additionally, up to 12 staff participants will be recruited.The goal of this project is to establish a gold standard for inpatient rehabilitation in the trauma NMSK injured population by widening the access to emotional wellbeing supports, which could translate into better physical, mental and social health in the community.
Detailed Description
Traumatic neuromusculoskeletal (NMSK) injuries result in significant disability and a high proportion of survivors suffer from chronic pain and mental health disorders. Inpatient acute care and rehabilitation are important treatments for patients after NMSK injury, however much of the work to ensure successful community participation occurs after discharge. A key mechanism for predicting outcomes following trauma is coping self-efficacy, therefore interventions that enhance coping self-efficacy post-NMSK injury are most likely to optimize recovery. However, these interventions are not standard approaches in rehabilitation settings. Our inter-disciplinary team will undertake a feasibility randomized control trial (RCT) to assess the efficacy of supportive-expressive group therapy (SEGT) in NMSK injury rehabilitation inpatients. It is hypothesized that persons who undergo the SEGT will yield significant improvements in coping self-efficacy compared to those receiving standard care. A prospective feasibility RCT design will be used to evaluate SEGT for NMSK injury rehabilitation inpatients compared to the standard rehabilitation for trauma patients at St John's Rehab (SJR). Sixty patients with an NMSK injury admitted to SJR will be randomized to either SEGT (n=30) or to standard rehabilitation (n=30). Additionally, up to 12 staff participants will be recruited to complete qualitative interviews/focus groups. A repeated measures ANOVA will be used to detect differences on the outcome measures, which will include a group, time, and groups by time interaction term. Linear regression will be used to adjust for potential covariates of interest. A thematic content analysis will be used to analyze the qualitative data. The long-term outcomes of this project is to establish a gold standard for inpatient rehabilitation in the trauma NMSK injured population by widening the access to emotional wellbeing supports, which could translate into better physical, mental and social health in the community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Injury, Traumatic Injury
Keywords
Group Therapy, Neuromusculoskeletal Traumatic Injury, Feasibility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Statistician analyzing the data will be blinded to group allocation
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive-expressive group therapy
Arm Type
Experimental
Arm Description
The SEGT is a six-module program where each session is approximately one hour, and is held twice a week over a three-week period. It is framed within social cognitive theory, whereby resilience to adversity (NMSK trauma in this instance) relies on personal enablement. Enablement serves to equip the individual with the personal resources to cultivate their self-efficacy and mastery and to select and construct environments that promote successful adaption.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation).
Intervention Type
Behavioral
Intervention Name(s)
Supportive Expressive Group Therapy
Intervention Description
The SEGT is a six-module program where each session is approximately one hour, and is held twice a week over a three-week period. It is framed within social cognitive theory, whereby resilience to adversity (NMSK trauma in this instance) relies on personal enablement. Enablement serves to equip the individual with the personal resources to cultivate their self-efficacy and mastery and to select and construct environments that promote successful adaption.
Primary Outcome Measure Information:
Title
Participant recruitment
Description
Number of participants who are recruited into the study and are contacted for assessments at set time intervals.
Time Frame
Through study completion, an average of 1 year.
Title
Questionnaire completion rates
Description
Number of completed assessments
Time Frame
Through study completion, an average of 1 year.
Title
Treatment adherence
Description
Number of participants who complete all 6 SEGT sessions
Time Frame
Through study completion, an average of 1 year.
Title
Number of participants contacted for follow up interview
Description
Number of participants contacted for follow up interview
Time Frame
At 1 month-post discharge for SEGT group]
Title
Participant retention
Description
Number of participants who complete the 3 month post-discharge assessments
Time Frame
At three months post-discharge for SEGT and control group
Title
Participant Retention
Description
Number of participants who complete 1 month post-discharge interview
Time Frame
At one month post-discharge for SEGT group]
Title
Barriers and Facilitators to Group Participation
Description
As discussed in qualitative interviews
Time Frame
At one month post-discharge for SEGT group
Secondary Outcome Measure Information:
Title
Change in Health-related quality of life
Description
Short Form-36 Survey (SF-36): The SF-36 is the most widely used generic health-related QoL tool. The tool measures 8 domains including physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, social functioning, general mental health, role limitations due to emotional problems, and vitality. The minimum score is 0, and the maximum is 100. Higher scores on the measure are indicative of less disability.
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Title
Change in coping self-efficacy
Description
Coping Self-Efficacy Scale (CSES): The CSES is a measures perceived self-efficacy for coping with challenges and threats. It is a 26-item measure rated using an 11-point scale with the anchors 0 (cannot do at), 5 (moderately certain can do), and 10 (certain can do). Total scores (ranging from 0-260) are calculated by summing the item scores and a higher score indicates higher coping self-efficacy.
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Title
Change in impact of traumatic life event
Description
Impact Event Scale Revised (IES-R): The IES44 is a 15-item scale that assesses the impact of a traumatic life event, and has two subscales assessing the frequency of intrusive and avoidant cognitions associated with a specific stressor. It uses a 4-point scale, not at all to often to assess how often a respondent experienced specific symptoms during the past week. The IES was revised 45 to assess the three cluster symptoms of PTSD: intrusions, avoidance, and hyperarousal. Scores range from 0-88, with higher scores indicating more severe impact.
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Title
Change in post-traumatic stress disorder
Description
Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C): The PCL-C47 is a standardized 17-item self-report rating scale for PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point scale, with higher scores indicating more severe levels of PTSD, and it is a well-validated measure across different populations. Scores range from a minimum of 0, to a maximum of 80.
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Title
Change in post-traumatic growth
Description
Post-Traumatic Growth Inventory (PTGI): The PTGI is a 21-item scale assessing positive outcomes reported by those who have experienced traumatic events.48 Items are scored on a 6-point scale and scores range from 0 to 105, with higher scores indicating greater levels of growth. It has good levels of internal consistency reliability (α=.90) and 2-month test-retest stability (r =.71).
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Other Pre-specified Outcome Measures:
Title
Socio-demographics
Description
Data will be collected on the following: age, gender, marital status, highest level of education achieved, living situation (live alone, live with spouse, live with others), smoking status, alcohol/illicit drug use (yes, no; if yes, type and frequency of use), annual income after taxes, third-party insurance (yes, no), and employment status (employed, unemployed, retired, etc.), number/type of comorbid conditions, number/type of medications used by participant.
Time Frame
A. 24-48 hours before intervention (baseline)
Title
Injury Characteristics
Description
The cause of injury will be obtained using the following categories: in a motor vehicle accident, hit by motor vehicle, fall, assault, stab, gunshot wound, recreational injury, and other. As well, whether the injury was unintentional, self-inflicted, assault, or cause unknown will be recorded.
Time Frame
A. 24-48 hours before intervention (baseline)
Title
Change in Injury Severity
Description
Injury Severity Score (ISS): ISS49 assesses trauma severity, and correlates with mortality, morbidity and hospitalization time after trauma and is used to define the term 'major trauma'. ISS scores range from 0 to 75, and a major trauma is defined as an ISS being greater than 15.
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Title
Change in experiences in close relationships
Description
Experiences in Close Relationships inventory-Short Form (ECR-S): The 12-item ECR-S evaluates the construct of adult attachment.50 Participants rate each of the 36 statements about connection using a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). There is a minimum score of 7 and a maximum score of 42. Higher percentiles indicate more difficulty with attachment.
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Title
Change in Personality
Description
Ten Item Personality Measure (TIPI): The TIPI assesses the Five-Factor Model of personality (agreeableness, neuroticism, conscientiousness, introversion, extraversion).52 It has adequate levels in terms of (a) convergence with widely used Big-Five measures in self, observer, and peer reports, (b) test-retest reliability, and (c) convergence between self and observer ratings.52 Each personality scale is measured on a scale of 1 (strongly disagree) to 7 ( strongly agree). Personality is an important determinant of outcome following injury as certain personality types may respond better to specific types of treatment,53 and has implications for the occurrence of PTSD.54
Time Frame
A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Title
Reintegration
Description
Reintegration to Normal Living (RNL) Index: The RNL Index56 covers such areas as involvement in recreational and social activities, perceived ability to move within the community, and the degree of comfort people have with their relationships. It is a valid and reliable tool for assessing participation in various populations.56 Minimum score is 0 and maximum score is 100. Higher scores represent higher levels of participation.
Time Frame
3 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking adults aged 18 years and older. Admitted to SJR for inpatient rehabilitation. Trauma-related peripheral nerve injury, muscle injury, amputation, and/or fracture(s). Are medically stable. Have no clinical suspicion of cognitive impairment or unstable severe mental health diagnosis (e.g. moderate/severe brain injury, schizophrenia, dementia, etc.). Exclusion Criteria: Are actively suicidal. Are unable participate effectively in a group setting (e.g. actively using substances, exhibiting threatening behaviors).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalie Steinberg
Phone
416-480-4089
Email
rosalie.steinberg@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalie Steinberg, MSc, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 2G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oksana Kachmarchuk, MSc
Phone
416-226-6780
Ext
57619
Email
oksana.kachmarchuk@sri.utoronto.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25015790
Citation
Nota SP, Bot AG, Ring D, Kloen P. Disability and depression after orthopaedic trauma. Injury. 2015 Feb;46(2):207-12. doi: 10.1016/j.injury.2014.06.012. Epub 2014 Jun 21.
Results Reference
background
Citation
Robinson LR. Trauma Rehabilitation. Lippincott Williams and Wilkins; 2006.
Results Reference
background
PubMed Identifier
24500592
Citation
Vranceanu AM, Bachoura A, Weening A, Vrahas M, Smith RM, Ring D. Psychological factors predict disability and pain intensity after skeletal trauma. J Bone Joint Surg Am. 2014 Feb 5;96(3):e20. doi: 10.2106/JBJS.L.00479.
Results Reference
background
Citation
Bandura A. Self-efficacy. The exercise of control. W.H. Freeman and Company; 1997.
Results Reference
background
PubMed Identifier
24001198
Citation
Connolly FR, Aitken LM, Tower M. An integrative review of self-efficacy and patient recovery post acute injury. J Adv Nurs. 2014 Apr;70(4):714-28. doi: 10.1111/jan.12237. Epub 2013 Sep 4.
Results Reference
background
PubMed Identifier
25875423
Citation
Bosmans MW, van der Velden PG. Longitudinal interplay between posttraumatic stress symptoms and coping self-efficacy: A four-wave prospective study. Soc Sci Med. 2015 Jun;134:23-9. doi: 10.1016/j.socscimed.2015.04.007. Epub 2015 Apr 9. Erratum In: Soc Sci Med. 2015 Jul;136-137:189.
Results Reference
background
PubMed Identifier
18665695
Citation
Benight CC, Cieslak R, Molton IR, Johnson LE. Self-evaluative appraisals of coping capability and posttraumatic distress following motor vehicle accidents. J Consult Clin Psychol. 2008 Aug;76(4):677-85. doi: 10.1037/0022-006X.76.4.677.
Results Reference
background
Citation
Bei E, Kupeli N, Candy B. 47 The impact of supportive-expressive group therapy (SEGT) as an intervention on health-related outcomes and social support for people with advanced disease: a systematic review. BMJ Supportive & Palliative Care. 2018;8(3):377-378. doi:10.1136/bmjspcare-2018-mariecurie.47
Results Reference
background

Learn more about this trial

A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma

We'll reach out to this number within 24 hrs