Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change in depression
研究概览
简要总结
In Canada the prevalence of spinal cord injury (SCI) is approximately 85,556, with incidence rates of traumatic and non-traumatic SCI at 1,785 and 2,286 cases per year, respectively. Common secondary health conditions experienced by individuals with SCI include psychological distress and pain. Appropriate management of these secondary conditions, through a multidisciplinary approach, is imperative as they have been shown to contribute to slower recovery, increased negative outcomes, and greater rates of rehospitalizations and health care utilization. However, resource limitations can restrict the ability of service providers to deliver these integrative biopsychosocial approaches in the community. Guided internet delivered cognitive behavioural therapy (ICBT) program offers an alternative approach for psychosocial service delivery in the community. The program provides online structured self-help modules based on the principles of cognitive behavioural therapy (CBT) in combination with guidance from a coach through weekly emails and telephone calls. ICBT was shown to have similar effects to face-to-face CBT. Results from the investigator's pilot pre-post study (ClinicalTrials.gov: NCT03457714), found significant effects of guided ICBT on primary outcome of depression (d=1.20, p=.02) post-intervention and gains were maintained at 3-month follow-up among persons with SCI. Significant improvements in secondary outcomes including pain interference, resilience, positive affect, self-efficacy, ability to participate, and grief were also found.These studies demonstrate that guided ICBT is a safe and effective alternative to face-to-face interventions and it may be beneficial for underserviced populations.
In the proposed trial, the investigators will examine the efficacy of the Guided ICBT Chronic Conditions Course for persons with SCI versus an online SCI Rehabilitation Education program. All participants will complete questionnaires prior to the start of the program, before each lesson of the program, once they have completed the program, and 3 months after completing the program. The primary outcome measures include anxiety and depression. As part of the battery of questionnaires administered after the completion of the program, clients will be asked to rate the program content, the overall service, and their satisfaction with the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •residing in Canada
- •endorsing symptoms of anxiety or depression
- •diagnosed with a spinal cord injury
- •condition does not impact ability to complete treatment (ex.cognitive impairment)
- •able to access a computer and internet service
- •willing to provide a physician as emergency contact
排除标准
- •high suicide risk
- •suicide attempt or hospitalization in the last year
- •primary problems with psychosis, alcohol or drug problems, mania
- •currently receiving active psychological treatment for anxiety or depression
- •not present in country during treatment
- •concerns about online therapy
研究组 & 干预措施
SCI internet delivered cognitive behavioural therapy
An 8-week internet- delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a health educator with experience delivering ICBT will provide support by email once a week. The health educator will spend approximately 15 minutes per week/per client.
干预措施: Guided ICBT (Behavioral)
SCI rehabilitation mental health education
Participants will receive information provided to SCI patients in usual care at specialized SCI rehabilitation units (the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Community handouts available at: https://scireproject.com/community/handouts/). The lessons will include information on spinal cord injury rehabilitation: 1)spinal cord injury basics, 2)mental health after SCI, 3)pain after SCI, 4)understanding rehabilitation 5)summary of lessons through an online platform over 8 weeks. A health educator will check in with participants once a week to answer any content related questions. The health educator will spend approximately 15 minutes per week/per client.
干预措施: SCI rehabilitation mental health education (Other)
结局指标
主要结局
Change in depression
时间窗: baseline, 8 weeks, 3 months, 6 months
Measured by Patient Health Questionnaire - 9 Item (PHQ-9), Higher scores indicate greater levels of depression. 0-4 No Depression, 5-9 Mild, 10-14 Moderate, 15-19 Moderately Severe, \>19 Severe
Change in anxiety
时间窗: baseline, 8 weeks, 3 months, 6 months
Measured by Generalize Anxiety Disorder - 7 Item (GAD7), higher scores indicate greater level of anxiety. 0-4 Minimal, 5-9 Mild, 10-14 Moderate, 15-21 Severe
次要结局
- Change in pain: Brief Pain Inventory-Short Form(baseline, 8 weeks, 3 months, 6 months)
- Change in disability(baseline, 8 weeks, 3 months, 6 months)
- Change in quality of life symptoms: SCI-QoL-SF(baseline, 8 weeks, 3 months, 6 months)
- Change in psychological distress(baseline, 8 weeks, 3 months, 6 months)
- Treatment credibility(baseline and 8 weeks)
- Treatment satisfaction: Internet-CBT Treatment Satisfaction Measure(baseline and 8 weeks)
