A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Questionnaire completion rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician analyzing the data will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.).
排除标准
- •Are actively suicidal.
- •Are unable participate effectively in a group setting (e.g. actively using substances, exhibiting threatening behaviors).
研究组 & 干预措施
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.
干预措施: Supportive Expressive Group Therapy (Behavioral)
Treatment as usual
The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation).
结局指标
主要结局
Questionnaire completion rates
时间窗: Through study completion, an average of 1 year.
Number of completed assessments
Treatment adherence
时间窗: Through study completion, an average of 1 year.
Number of participants who complete all 6 SEGT sessions
Participant recruitment
时间窗: 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.
Number of participants contacted for follow up interview
时间窗: At 1 month-post discharge for SEGT group]
Number of participants contacted for follow up interview
Participant retention
时间窗: At three months post-discharge for SEGT and control group
Number of participants who complete the 3 month post-discharge assessments
Barriers and Facilitators to Group Participation
时间窗: At one month post-discharge for SEGT group
As discussed in qualitative interviews
Participant Retention
时间窗: At one month post-discharge for SEGT group]
Number of participants who complete 1 month post-discharge interview
次要结局
- 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 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 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 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 post-traumatic growth(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)