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A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma: Musculoskeletal Diseases and Conditions – Chronic Pain
2022 APR 25 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT05320445 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •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 | |
| Current Secondary Outcome Measures | •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 ] -- 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 are calculated by summing the item scores and a higher score indicates higher coping self-efficacy. | |
| •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 ] -- 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 revised45 to assess the three cluster symptoms of PTSD: intrusions, avoidance, and hyperarousal. | |
| •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 ] -- 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. | |
| •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 ] -- 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 (a=.90) and 2-month test-retest stability (r =.71). | |
| Other Outcome Measures | •Socio-demographics [ Time Frame: A. 24-48 hours before intervention (baseline) ] -- 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. |
| •Injury Characteristics [ Time Frame: A. 24-48 hours before intervention (baseline) ] -- 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. | |
| •Change in Injury Severity [ Time Frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge ] -- 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’. A major trauma is defined as an ISS being greater than 15. | |
| •Change in experiences in close relationships [ Time Frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge ] -- 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 are important links between post-traumatic stress and adult attachment51 that may influence outcomes in our trial. | |
| •Change in Personality [ Time Frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge ] -- 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 © convergence between self and observer ratings.52 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 | |
| •Reintegration [ Time Frame: 3 months post-discharge ] -- 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 Higher scores represent higher levels of participation. | |
| Change History | Complete list of historical revisions of study NCT05320445 |
Descriptive Information
| Brief Title | A |
| Official Title | A |
| 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. |
| Study Type | Interventional |
| Study Phase | Not Applicable |
| Study Design | Allocation: Randomized |
| Intervention Model: Parallel Assignment | |
| Primary Purpose: Other | |
| Masking: Single | |
| Masking Description: Statistician analyzing the data will be blinded to group allocation | |
| Condition | Musculoskeletal Injury |
| Traumatic Injury | |
| Intervention | •Behavioral: Supportive Expressive Group Therapy |
| 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 Arms | •Experimental: Supportive-expressive group therapy |
| 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 | |
| Interventions: | |
| ⚬Behavioral: Supportive Expressive Group Therapy | |
| Publications* | *Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline |
| PubMed Link - Nota SP, |
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| Robinson LR. Trauma Rehabilitation. |
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| PubMed Link - 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 |
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| Bandura A. Self-efficacy. The exercise of control. |
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| PubMed Link - Connolly FR, |
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| PubMed Link - 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 |
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| PubMed Link - 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. | |
| 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 |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 60 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | 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). |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 18 years and older |
| Yes | |
| Contacts | Primary contact: |
| Listed Location Countries | Not Provided |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT05320445 |
| Other Study ID Numbers | 4859 |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | No |
| Plan to Share Data (IPD) Description | Not Provided |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: |
| Information Provided By | |
| Verification Date |
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