Using a Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Limb Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Participant recruitment
研究概览
简要总结
People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety, social isolation, and generally have poor quality of life. To proactively address the mental health needs of this population, this study plans to test an innovative psychological group therapy program designed for limb loss inpatients to enhance coping skills, address mental health challenges, and better prepare them to integrate back into the community via a randomized blinded feasibility trial. Since this is a novel intervention, adapted specifically for limb loss, this study will test the feasibility of delivering this inpatient group program to these at-risk individuals to see: if they will participate in the program, what they like/do not like about it, and if there are some early findings suggesting it is effective. Researchers will use these results to improve the psychosocial group program and to further test its effectiveness in a larger clinical study.
详细描述
Lower limb extremity amputation (LEA) is a debilitating event that negatively affects many aspects of an individual's life, such as their mobility, physical and mental health, and ultimately quality of life (QoL). Due to the high rates of diabetes in Canada, the most common type of limb loss is dysvascular due to complications of diabetes/vascular disease.
Compared to other limb loss populations (trauma or tumor), people with dysvascular LEA have been shown to have poorer QoL. Premorbid comorbidities (e.g. coronary heart disease, etc.), and post-morbid complications such as depression, anxiety and chronic pain further impact wellbeing. Sequelae of these issues include impaired body image, and high rates of suicidal ideation. Rates of depression have been found to be as high as 60%; comorbid depression is associated with lower prosthetic use, higher perceived vulnerability, and lower self-rated overall health. Providers, however, often focus efforts on the patients' physical recovery post-LEA and may not adequately address psychosocial functioning.
There is some preliminary evidence on the efficacy of group therapy approaches for limb loss patients undergoing inpatient rehabilitation in India, and outpatient rehabilitation in Canada, but findings are limited and may not be fully generalizable to dysvascular LEA.
Hence, the planned innovative intervention will provide clarification on the feasibility of undertaking a larger scale trial to assess the efficacy of an inpatient group therapy approach to address the mental health concerns (i.e., depression and anxiety) and psychosocial needs (i.e. coping skills) of limb loss patients. Based on available knowledge, this would be the first of its kind in Canada.
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
The Research Coordinator and 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 adult inpatients (18 years and older)
- •Dysvascular-related lower extremity amputation
- •Medically stable
- •No clinical suspicion of cognitive impairment
- •No history of active psychosis or unstable severe mental health diagnosis (no diagnosis of schizophrenia, dementia, etc.)
- •Admitted inpatients to St. John's Rehab Hospital (Sunnybrook Health Sciences Centre).
排除标准
- •Actively suicidal
- •Unable participate effectively in a group setting
- •Non-dysvascular lower extremity amputation
- •Non-English-speaking
- •Children (under the age of 18)
- •Medically unstable
- •Clinical suspicion of cognitive impairment
- •History of active psychosis or unstable severe mental health diagnosis (diagnosis of schizophrenia, dementia, etc.)
- •Staff Inclusion Criteria: (Note: Staff will not be part of intervention, but will be asked to share their perspectives on the intervention)
- •Clinical staff who work on the inpatient A1 unit at St. John's Rehab (Sunnybrook Health Sciences Centre)
- •Staff Exclusion Criteria:
- •Casual or contract staff who have worked on the inpatient A1 unit.
- •Non-St. John's Rehab Hospital staff
结局指标
主要结局
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.
Questionnaire completion rates
时间窗: At 3 months post-discharge for SEGT and control group.
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 retention
时间窗: At one month post-discharge for SEGT group
Number of participants who complete 1 month post-discharge interview
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
次要结局
- Change in Depression and Anxiety(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)
- Change in Self-efficacy(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)
- Change in Body image(A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge)
- Psychiatric consultations(Through study completion, an average of 1 year.)
- 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 Community participation(A. 3 months post-discharge)