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

NCT05320445 | Completed

• 1 other identifier: 4859
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Injury; Traumatic Injury

Keywords

Group Therapy; Neuromusculoskeletal Traumatic Injury; Feasibility

Outcome Measures

Primary Outcomes (7)

• Participant recruitment

  Number of participants who are recruited into the study and are contacted for assessments at set time intervals.

  Through study completion, an average of 1 year.

• Questionnaire completion rates

  Number of completed assessments

  Through study completion, an average of 1 year.

• Treatment adherence

  Number of participants who complete all 6 SEGT sessions

  Through study completion, an average of 1 year.

• Number of participants contacted for follow up interview

  Number of participants contacted for follow up interview

  At 1 month-post discharge for SEGT group]

• Participant retention

  Number of participants who complete the 3 month post-discharge assessments

  At three months post-discharge for SEGT and control group

• Participant Retention

  Number of participants who complete 1 month post-discharge interview

  At one month post-discharge for SEGT group]

• Barriers and Facilitators to Group Participation

  As discussed in qualitative interviews

  At one month post-discharge for SEGT group

Secondary Outcomes (5)

• Change in Health-related quality of life

  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

  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

  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

  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

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

Other Outcomes (6)

• Socio-demographics

  A. 24-48 hours before intervention (baseline)

• Injury Characteristics

  A. 24-48 hours before intervention (baseline)

• Change in Injury Severity

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

Study Arms (2)

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.

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).

Interventions

Supportive Expressive Group Therapy BEHAVIORAL

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.

Supportive-expressive group therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M2M 2G1, Canada

Location

Related Publications (8)

• 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.

  PMID: 25015790 BACKGROUND

• Robinson LR. Trauma Rehabilitation. Lippincott Williams and Wilkins; 2006.

  BACKGROUND

• 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.

  PMID: 24500592 BACKGROUND

• Bandura A. Self-efficacy. The exercise of control. W.H. Freeman and Company; 1997.

  BACKGROUND

• 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.

  PMID: 24001198 BACKGROUND

• 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.

  PMID: 25875423 BACKGROUND

• 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.

  PMID: 18665695 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Rosalie Steinberg, MSc, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician analyzing the data will be blinded to group allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: January 23, 2023
• Primary Completion: March 18, 2024
• Study Completion: August 14, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)