跳至主要内容
临床试验/NCT03963843
NCT03963843已完成不适用

Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury: Randomized Controlled Trial

University of Regina4 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2019年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
4
主要终点
Change in anxiety

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

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

结局指标

主要结局

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

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

次要结局

  • Change in psychological distress(baseline, 8 weeks, 3 months, 6 months)
  • 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)
  • Treatment credibility(baseline and 8 weeks)
  • Treatment satisfaction: Internet-CBT Treatment Satisfaction Measure(baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验