Musculoskeletal InjuryNCT05320445
A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma
A study testing Supportive Expressive Group Therapy in people with Musculoskeletal Injury and Traumatic Injury, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury, Traumatic Injury
- What is being tested?
- Supportive Expressive Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2023to 14 Aug 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- Are actively suicidal.
- Are unable participate effectively in a group setting (e.g. actively using substances, exhibiting threatening behaviors).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Musculoskeletal Injury, Traumatic Injury
- Being tested
- Supportive Expressive Group Therapy
- Keywords
- Group Therapy, Neuromusculoskeletal Traumatic Injury, Feasibility
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Expressive Group TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supportive-expressive group therapy | Experimental | 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. Receives: Behavioral: Supportive Expressive Group Therapy |
| Treatment as usual | No intervention | The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
Number of participants who are recruited into the study and are contacted for assessments at set time intervals.
Measured: Through study completion, an average of 1 year.
Questionnaire completion rates
Number of completed assessments
Measured: Through study completion, an average of 1 year.
Treatment adherence
Number of participants who complete all 6 SEGT sessions
Measured: Through study completion, an average of 1 year.
Number of participants contacted for follow up interview
Number of participants contacted for follow up interview
Measured: At 1 month-post discharge for SEGT group]
Participant retention
Number of participants who complete the 3 month post-discharge assessments
Measured: At three months post-discharge for SEGT and control group
Participant Retention
Number of participants who complete 1 month post-discharge interview
Measured: At one month post-discharge for SEGT group]
Barriers and Facilitators to Group Participation
As discussed in qualitative interviews
Measured: At one month post-discharge for SEGT group
Secondary outcomes (5)
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.
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
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.
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
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.
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
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.
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
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).
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start23 Jan 2023
- Primary completion18 Mar 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosalie Steinberg, MSc, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320445
- Sponsor's protocol ID
- 4859
- Status last verified
- Dec 2023
- First submitted
- 1 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25015790Robinson LR. Trauma Rehabilitation. Lippincott Williams and Wilkins; 2006.
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.
PubMed 24500592Bandura A. Self-efficacy. The exercise of control. W.H. Freeman and Company; 1997.
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.
PubMed 24001198Bosmans 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.
PubMed 25875423Benight 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.
PubMed 18665695Bei 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma
- ClinicalTrials.gov ID
- NCT05320445
- Acronym / sponsor ID
- 4859
- Conditions
- Musculoskeletal Injury, Traumatic Injury
- Keywords
- Group Therapy, Neuromusculoskeletal Traumatic Injury, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 11 Apr 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive-expressive group therapy | Experimental | Behavioral: Supportive Expressive Group TherapyThe 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. |
| Treatment as usual | No intervention | –The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.).
Key exclusion criteria (2 listed)
- Are actively suicidal.
- Are unable participate effectively in a group setting (e.g. actively using substances, exhibiting threatening behaviors).
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 |
|---|---|---|
| Supportive Expressive Group TherapyThe 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. | Behavioural | Supportive-expressive group therapy |
Primary outcome
Participant recruitment
Time frame: Through study completion, an average of 1 year.
Number of participants who are recruited into the study and are contacted for assessments at set time intervals.
Questionnaire completion rates
Time frame: Through study completion, an average of 1 year.
Number of completed assessments
Treatment adherence
Time frame: Through study completion, an average of 1 year.
Number of participants who complete all 6 SEGT sessions
Number of participants contacted for follow up interview
Time frame: At 1 month-post discharge for SEGT group]
Number of participants contacted for follow up interview
Participant retention
Time frame: At three months post-discharge for SEGT and control group
Number of participants who complete the 3 month post-discharge assessments
Participant Retention
Time frame: At one month post-discharge for SEGT group]
Number of participants who complete 1 month post-discharge interview
Barriers and Facilitators to Group Participation
Time frame: At one month post-discharge for SEGT group
As discussed in qualitative interviews
5 secondary outcomes
Change in Health-related quality of life
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in 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
Change in impact of traumatic life event
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in post-traumatic stress disorder
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in post-traumatic growth
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25015790Nota 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.
- BackgroundRobinson LR. Trauma Rehabilitation. Lippincott Williams and Wilkins; 2006.
- Background: PubMed 24500592Vranceanu 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.
- BackgroundBandura A. Self-efficacy. The exercise of control. W.H. Freeman and Company; 1997.
- Background: PubMed 24001198Connolly 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.
- Background: PubMed 25875423Bosmans 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.
- Background: PubMed 18665695Benight 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.
- BackgroundBei 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
- Individual participant dataSharing planned: No
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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.
Rosalie Steinberg, MSc, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Expressive Group Therapy in people with Musculoskeletal Injury and Traumatic Injury, run by Sunnybrook Health Sciences Centre 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: Through study completion, an average of 1 year.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320445, which also lists 8 linked publications.
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 19 Sep 2024.